chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urticaria around the site; Redness around the site; swelling around the site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Redness around the site) and INJECTION SITE SWELLING (swelling around the site) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Redness around the site) and INJECTION SITE SWELLING (swelling around the site). At the time of the report, INJECTION SITE ERYTHEMA (Redness around the site) and INJECTION SITE SWELLING (swelling around the site) 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.   No treatment information was provided.  No concomitant medication was provided.    This case was linked to MOD-2021-005587 (Patient Link).
Severe redness and pain at site of injection, fever requiring prednisone developed mental status changes, dizziness, hospitalized x 24 hours-neuro workup.
ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSTION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-JUL-2021, the patient experienced administration of vaccine from affected vials due to temperature excurstion. On 09-JUL-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excurstion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210916228, 20210916300, 20210916312, 20210916553, 20210916697, 20210915646, 20210915748, 20210915852, 20210916312, 20210916300, 20210916455, 20210916553, 20210916910, 20210917226, 20210916959, 20210917160, 20210915719, 20210916808, 20210915661, 20210915623, 20210916715, 20210917163, 20210916907, 20210916768, 20210917515 and 20210916658.
35 days after receiving vaccine, I started having an irregular heartbeat. It felt like a fluttering in my chest. Pulse difficult to count because of the arrhythmia. Very light SOB. I have history of occasional PVC. This is what it felt like only much more frequent and would not stop. I went to ER to be sure it was not some other type of arrhythmia. I took one Amlodipine 10mg on day 8 of the event (nonstop PVC's about 8 a minute for 8 days). Six hours later, PVC stopped and never returned.
None. Package insert had expiration date at 12/31/2069, unknown to us, this was not correct. Moderna found with proper storage, vaccine maintained the activity necessary to protect against the SARS-COV-2 virus at the time of administration. Viability check done by Moderna found vaccine to be viable and effective.
flu like sx, body ache, chills, fever, joint pain, stiffness-severe h/a, muscle weakness, profound weakness in extremities;trouble remembering & concentrating; Per follow-up dated 9/27/00, the pt continues to suffer from muscle pain, joint pain, extreme fatigue, elevated sed rates, dry eyes and mouth, nausea, and poor immune system. In January 1999, the pt was hospitalized twice; once for nausea and vomiting uncontrolled and once for suffering a small stroke.
no reaction until 30 hr after vaccination. Then had severe shivering lasting perhaps 2 hr followed by exhaustion and stiffness lasting through next day.  Third day after vaccination, shivers returned, fever no higher than 101 degrees, followed by heavy perspiration. Not sure when it will stop.
Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 42-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
Patient received the Pfizer vaccine lot # FK9896 Beyond Usage Date 03/31/2022 on 02/23/2022 at 1050am and the Flucelvax vaccine lot# 308497 exp 06/30/2022 at 1054am.  The client denied a history of allergies.  He reported a history of ?AIDS? and said he had ?shell shock.? At 1103am the client said, ?I feel dizzy.? RN gave the client a juice and retrieved the yoga matt for the client to lie down on while RN assisted the client to put his head down between his legs until the matt was available.  At 1104 am, RN helped the client lay down flat on the yoga mat while RN prepared to take the client's vital signs.  The RR was 18 and unlabored and his pulse was regular per palpation.  The client refused to allow RN or other RN to complete his vital signs.  At 1108 am, he said he felt ?all better.?  He denied any lasting feelings of dizziness and sat up on a chair independently.  He refused vitals while in a sitting position also.  At 1109am he said he felt fine and told RN and another RN that he was leaving and  then proceeded to stand up and walk away independently with a steady gait. RN educated the client about normal vaccine side effects and told him to seek care if his dizziness returned.
Pt was given an exp immunization 09/19/2021 Pt has had no reactions to immunization.
This spontaneous report as received from a Registered Nurse refers to a patient of unkonwn demographics. The patient's current conditions or medical history were not reported. On 27-MAR-2014, the patient was inadvertently administered a dose of ROTATEQ suspension 2, 2 ml oral lot number reported as H016881 that had expired on 22-MAR-2014. No adverse effects reported. Additional information has been requested.
SM did not receive any flu vaccines until she was in the military. She recalls that following her first flu vaccines, she developed vomiting, diarrhea and frequent bloody noses. She also developed symptoms of the flu including a cough. Talking and coughing led to vomiting and she was given a voice waiver. Most symptoms persisted x 3 mos during which time she was evaluated and treated, with no reported underlying cause. She eventually was told she had walking pneumonia. The bloody noses stopped after "charcoal" treatment by ENT. She avoided flu shots for a few years after that, but when she was required to take the seasonal flu shots annually, the first five years, she developed diarrhea and vomiting, as well as fatigue, fever, and aching. To the best of her recollection, her symptoms usually started within the first 24 hours after vaccine receipt and usually did not last more than 1-2 weeks. Since then, her reactions after receipt of seasonal flu vaccines do not include diarrhea and vomiting, but usually include viral-type symptoms, lasting for 1-2 weeks and requiring quarters following vaccine receipt. She denies developing hives/rashes, angioedema, difficulty breathing or swallowing. She does not recall specifics of receipts of FLUMIST (x2); specifically, she does not recall reacting differently to FLUMIST than to flu vaccines administered IM. Since 2007, after she skin tested negative for eggs, she has received only injectable flu vaccines. She has tried pretreatment with Naproxen 500 mg every 6 hours, starting 24 hours before vaccine receipt and continuing for 48 hours post-vaccine without a significant reduction in symptoms following vaccine receipt.
Patient complained pain/soreness in arm and fever. Patient was contacted next day, and informed us that she is feeling better but still on pain/fever.
This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 24-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown location. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
Bilateral dorsal hand pain starting 2 to 3 weeks after second dose. Pain rated from 5/10-7/10, aching for about 5 to 6 hours in the morning. Does not seem to be affected by how much he is using his hands the day before. No history of osteoarthritis or rheumatoid arthritis in the family. Patient believes he has noticed differences in the way his vascular appearance is in his hands.  On physical exam, hands appeared normal. Symptoms persisted for almost 7 months.  We did steroid burst, symptoms have improved but not gone away. Patient strongly believes this pain was due to his COVID-19 vaccination.
Headache, Myalgia, lymph node swelling under arms at left side Narrative:  missed one day of work, started about 10 to 12 hours after vaccine given
face devel rash & itching & was swollen;went to Md on 3NOV97 gave DPH didn't help also gave prescription for pred, titration packet if didn't help get filed started 5NOV97;better 7NOV97
15 minutes post injection, I was tachycardic, lightheaded, nearly fell over (nurse caught me as I started to sway), and my throat felt thick like something was stuck in it. Staff sat me into a recliner and called an ICU attending. Benedryl IM was given.  Throat symptoms did not get worse but did take about 10-12 hours to resolve.
Monovalent Pfizer was chart as a bivalent dose, which cause patient to get an additional bivalent dose two months later
0820 given vax went to school 830 w/itching, rash & breathing trouble (? hyperventilating); 911 called; pt given DPH IV & transported to hosp;
reaction to the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (reaction to the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ADVERSE DRUG REACTION (reaction to the Moderna vaccine). At the time of the report, ADVERSE DRUG REACTION (reaction to the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (reaction to the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ADVERSE DRUG REACTION (reaction to the Moderna vaccine). At the time of the report, ADVERSE DRUG REACTION (reaction to the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Temperature, headache, stomach-ache, nausea, stabbing pain in the heart,  24.07 - 1 day after vaccination(23.07) I felt very bad with all adverse, then took 1 tablet paracetamol,  temperature was gone. Next 2 days headache was left but feeling was better. 27.07 I felt normal
On June I got really sick and I do not know what I got sick with. I was sick for 2 weeks, I had no symptoms except for fever and severe fatigued. I could hardly hold my head up. I went to urgent care when they did not bother to run an EKG or any test because they said I was just sick. My blood pressure went down dramatically and I ended up going into atrial fibrillation. My blood pressure was around 89/40. I was having the hypotension along with palpitations. I was not doing anything besides my daily activities. I went to see my family practitioner. I had an EKG done on a Friday and it showed the atrial fibrillation. I went to see a cardiologist, and they have done all kinds of tests. The atrial fibrillation lasted 48 hours before it converted into normal sinus rhythm before I went to see the cardiologists. Now I am taking a lot of medications.
Narrative: COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 08/23 pt cc: no symptoms exposure: unknown 08/23 COVID swab, result: detected 09/03 COVID swab, result: not detected 09/13/ COVID swab, result: not detected
Within one hour after injection felt lightheaded. Next day headache sore throat. Several hours later red flat areas on legs, legs itchy.
16OCT woke up eyes puffy & sore, vision can't focus; 17OCT eye dark & puffy, tingling sensation around hard mouth, arm sore, inject site 2" round sore, red; seen by MD-rx for itching Doxipin & DPH;
Resident exhibited no adverse events during 30 minute monitoring following vaccine administration. Resident found without pulse at 1900.
CONGESTION; SORE THROAT; TIREDNESS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included fatigued, and soreness in throat, and concurrent conditions included alcohol use, and weather changes causes allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: guaifenesin. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, congestion, and sore throat. This report was non-serious.
Almost immediate onset of neck pain and numbness tingling in hand on the same side of injection.  About 30 minutes later face became numb on same side as injection including metallic taste in mouth and sore teeth. Feels like numbing from dentist office. It?s now 4 1/2 hours post injection and numb feeling in face and tingling hand exist.
syncope - had both blood draw and HPV#1 (Gardasil) Recovered
Arm would never stop hurting; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comments: This case was reported by patient via interactive digital media. It was reported that patient's arm hurt too. The patient thought that his/her arm would never stop hurting. The follow up would not be possible as contact details were not provided.
Patient received vaccine at approximately 2:00p on Tuesday, May 1, 2018. She reports on Wednesday, May 2, 2018, that she experienced a severe headache, muscle aches, fever, shivering, and fatigue that afternoon. Symptoms resolved by today, Thursday, May 3, 2018.
Approximately 24-30 hours after vaccination I experienced blurred vision. It began with what looked like someone had just taken a picture with a flash and progressed to blurred vision to the point of not being able to clearly read text messages on my phone. I have never had an ocular migraine, migraine or experienced migraine aura before but after researching them I suppose that is what it most closely resembled. It lasted about 30 minutes. The following day I experienced a headache that lasted until I took something OTC.
Left arm and side had numbness sensation for 3 days then went away, no other side affects; Left arm and side had numbness sensation for 3 days then went away, no other side affects; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0151, Expiration date were not reported) via an unspecified route of administration, administered on arm left on 28Apr2021 at 10:00 (age at vaccination was 40 years) as dose 1, single for COVID-19 immunization workplace clinic. No other vaccine in four weeks. On 28Apr2021 at 11:00 the patient developed Left arm and side had numbness sensation for 3 days then went away, no other side effects. No covid prior vaccination. No covid was tested post vaccination. No allergies were reported. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered on an unspecified date 2021.   Follow-up attempts completed. No further information expected.
Patient fully vaccinated with Pfizer vaccine 1/28/21 and 2/17/21.    Patient developed COVID infection 9/17/21 and received antibody infusion 9/20/21 -- this all through urgent care center.   On 9/28/21  patient had follow up appointment with MD and noted to have rapid heart rate and was sent to the ED.  Patient admitted with AF with RVR and underwent a TEE/CV and ultimately required a pacemaker insertion.    The atrial fibrillation with rapid ventricular response possibly related to recent COVID breakthrough infection.
I was feeling unusual symptoms of runny nose, cough, scratchy throat. Requested to be tested for COVID-19 and test positive by nurse in assisted living facility.
10/18/11 8pm - Headache, pain in neck/upper back, tingling on hands & feet. 10/19/11 9am - same symptoms. 10/20/11 12pm - tingling in hands & feet only, pt made appointment with MD (nerve tests done). 10/22/11 3pm - Still tingling, less noticeable, MD office verified. Nerve function OK.
Adverse reaction started about 3 hours after injection.    Had   headache (6 to 7 on pain scale) which lasted  24 hours, accompanied with tiredness, mild arm pain, chills, muscle aches.    Adverse reactions began resolving late afternoon of September 29. Had similar adverse reaction with FIRST shingrix injection which was not reported to VAERS.   First shingrix adverse reactions lasted 1 day longer then adverse reaction from SECOND shingrix.
The wife of a male, who had been in his 20's reported that her husband received an injection of Tetanus Toxoid 8 to 10 years ago and experienced "general malaise"  which lasted approximately 10 months.
SUMMARY OF PATIENT PROGRESS:   STATUS: Progressing as expected towards goals - continuing present plan   Primary Problem: COVID-19 DISEASE    Key findings related to primary problem: Pt AxO x3. VSS. On 2L NC. No complaints of pain. Pt repositioned. Right hip dressing CDI. Male purewick in place. IV abx.   Other key findings: Bed alarm on. Call light within reach. BP 130/54  | Pulse 61  | Temp 98.2 °F (36.8 °C)  | Resp 20  | Ht 1.854 m (6' 1")  | Wt 93.7 kg (206 lb 9.1 oz)  | SpO2 97%  | BMI 27.25 kg/m²        Problem: Confusion Acute Goal: Optimal Cognitive Function Outcome: Progressing   Problem: Adult Inpatient Plan of Care Goal: Plan of Care Review Outcome: Progressing Goal: Patient-Specific Goal (Individualized) Outcome: Progressing Goal: Absence of Hospital-Acquired Illness or Injury Outcome: Progressing Goal: Optimal Comfort and Wellbeing Outcome: Progressing   Problem: Fall Injury Risk Goal: Absence of Fall and Fall-Related Injury Outcome: Progressing   Problem: Skin Injury Risk Increased Goal: Skin Health and Integrity Outcome: Progressing   Problem: Infection Goal: Absence of Infection Signs and Symptoms Outcome: Progressing           Note Details  Author (R.N.) File Time 9/18/2023  1:59 PM Author Type REGISTERED NURSE Status Signed Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct #  Admit Date 9/14/2023  ED to Hosp-Admission (Discharged) on 9/14/2023  ED to Hosp-Admission (Discharged) on 9/14/2023   Detailed Report  Note shared with patient Care Timeline  09/14   Admitted from ED (Observation) 1918 09/16   Admitted 0746 09/18   Discharged 1645
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 at 12:00 as dose 1, single (Lot number: EM9810), in right arm, on 25Feb2021 at 13:00 as dose 2, single (Lot number: EN6203), in right arm, on 23Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 11Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Apr2014, stop date: 08Oct2022; TAMSULOSIN, start date: 01Oct2018, stop date: 08Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Incorrect dose given. Patient was due to receive Pfizer 5-11 Bivalent and received Pfizer 12+ Bivalent
Saturday, December 5, 2009-reports dizziness, weakness, tachycardia and headache in the morning. She reports the symptoms went away the same day.