chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased bleeding during period; Itching; Vaginal dryness; Vaginal pain; Difficulty sleeping; Circular pattern; Sharp pain; Tendon pain; Bump on underarm; Arm pain; Tirdness; Headache; Nausea; Throwing up; Arm swelling; Not being able to lift up arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain) and TENDON PAIN (Tendon pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), LIMB DISCOMFORT (Not being able to lift up arm) and VOMITING (Throwing up). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Tirdness), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Mar-2021, the patient experienced MASS (Bump on underarm). On 16-Mar-2021, the patient experienced PAIN (Sharp pain), TENDON PAIN (Tendon pain) and RASH (Circular pattern). On 17-Mar-2021, the patient experienced INSOMNIA (Difficulty sleeping). On 22-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness) and VULVOVAGINAL PAIN (Vaginal pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling), MASS (Bump on underarm), PAIN IN EXTREMITY (Arm pain), PAIN (Sharp pain), TENDON PAIN (Tendon pain), INSOMNIA (Difficulty sleeping), HEAVY MENSTRUAL BLEEDING (Increased bleeding during period), PRURITUS (Itching), VULVOVAGINAL DRYNESS (Vaginal dryness), VULVOVAGINAL PAIN (Vaginal pain), LIMB DISCOMFORT (Not being able to lift up arm), RASH (Circular pattern), FATIGUE (Tirdness), VOMITING (Throwing up), HEADACHE (Headache) and NAUSEA (Nausea) 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 concomitant medications were reported
Systemic: Dizziness / Lightheadness-Mild, Systemic: patient felt lightheaded.  Pt thought he wa going to faint. Pt never fainted but we called 911. They said his vitals were fine. Pt and EMT both agreed he should go to ER for observation.-Mild
Vaccination failure; Tested positive for COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (Tested positive for COVID-19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Apple), Drug allergy (Codeine), Fruit allergy (Peach) and Allergy to nuts (Pistachio nut).   On 17-Mar-2021 at 8:07 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Apr-2021 at 6:09 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Dec-2021, the patient experienced VACCINATION FAILURE (Vaccination failure). 30-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive (Rapid test).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 37-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID-19. Vaccination failure was considered as an additional event. The event occurred approximately 8 months after the second dose of mRNA-1273 Vaccine. Patient tested positive for COVID 19 by Rapid test. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-503875 (Patient Link). Sender's Comments: This spontaneous case concerns a 37-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID-19. Vaccination failure was considered as an additional event. The event occurred approximately 8 months after the second dose of mRNA-1273 Vaccine. Patient tested positive for COVID 19 by Rapid test. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Parents report baby cried for 4 solid hours with a high pitch cry and then was fussy for another day but then within a day or 2 was back to normal
pt recv vax 15JUN95 & 25JUN96 IgG antibody titer was 0.8 (greater than 1.0 immunity);
racing heartbeat; body aches; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (racing heartbeat), PAIN (body aches) and CHILLS (CHILLS) 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 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 25-Feb-2021, the patient experienced HEART RATE INCREASED (racing heartbeat), PAIN (body aches) and CHILLS (CHILLS). At the time of the report, HEART RATE INCREASED (racing heartbeat), PAIN (body aches) and CHILLS (CHILLS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant information use was not reported.  Treatment information was not provided.
started w/severe h/a started @ 1PM APAP given in office-h/a lasted 20 hrs; 3PM t101.5 ax (lasted 48 hrs 99-101.5 ax); 7PM vomited x 4; today arm is red & sore;
Starting from 12 hours after receiving the second dose of Covid vaccine,  I?m experiencing palpitations, fatigue, muscle pain and dizziness. I took Tylenol and felt better
PRODUCT STORAGE ERROR; This spontaneous report was received from a licensed practical nurse regarding a 4 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 14-DEC-2020, the patient received improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S037501, expiration date of 20-NOV-2021, subcutaneous in left arm and  varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017686 with expiration date of 21-MAY-2022, subcutaneous in the left arm for prophylaxis.  The vaccines experienced temperature excursions with a total of 29.5h.  This is one of several reports from the same reporter(US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:
Patient developed cellulitis 1 day after Tdap administration on 8/6/07. On 8/9/07 patient treated with Keflex x 7 days.
Client was given one dose of adult Hep A vaccine instead of a pediatric dose. Mother advised and will be assessing for adverse signs/symptoms.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Patient's current condition or medical history was not reported. On 09-FEB-2015 the patient was vaccinated with a dose of RECOMBIVAX HB (lot#, dose not reported, intramuscularly) which underwent a non supported temperature excursion. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Daughter developed diffuse pruritic maculopapular rash on face, with isolated red patches on right arm and right leg as well.  The index patch was on right leg; it developed within 24 hours of the flu shot administration.  The next patch was on her right arm (within 36 hours).  48 hours after the shot, I discovered she had the facial rash when I woke her up that morning.  She is currently being treated with oral antihistamines and Rx-strength topical corticosteroids.  I recall that she had a similar reaction to another vaccine at approximately 1 year of age, though I cannot remember which vaccine precipitated the reaction.   I submitted a VAERS report then as well, temporary ID was 167498.
After the first vaccine (010421), severe joint pain in multiple joints ensued, as well as severe fatigue.  Within 24 hours of the second vaccination (administered 020121), a severe flare of inflammatory arthritis ensued, requiring a visit to the rheumatologist.  CRP was 13; and xrays showed new inflammatory arthritis in hands and feet. Over the course of the next 6 days, in addition to severe joint pain and fatigue, both severe vomiting and diarrhea occurred (which NEVER happened in the past)  resulting in an inability to adequately hydrate, 10 lbs weight loss in  a normal BMI, and culminating in an ER visit 02 10 2021 requiring IV fluids, due to vomiting and diarrhea.  DX: Enterocolitis per CT scan w contrast.   Also, a new DX of RA was made and methotrexate was prescribed.   All of this started after the first Moderna dose in Jan 2021 and was significantly exacerbated after the 2nd dose FEb 2021.  I was the chair of a serious adverse events subcommittee for 5 years for an Institutional Review Board.  I have been a clinical scientist since the 1990s.  This is DEFINITELY RELATED.  NOT EVEN POSSIBLY RELATED BUT DEFINITELY.  JUST PURE HELL SINCE THE VACCINE.
Child awoke 36-48 hrs after vaccine with red rash to face, ears, neck, chest, arms and legs. Took benadryl and within a few hours rash had improved
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 10-AUG-2015, a patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # I012036, expiry date: 07-APR-2016) (dose, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I'm 36 weeks pregnant and have had both doses of the Moderna Covid vaccine. I want to know if it's safe to get a third dose right now?; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I'm 36 weeks pregnant and have had both doses of the Moderna Covid vaccine. I want to know if it's safe to get a third dose right now?) 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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I'm 36 weeks pregnant and have had both doses of the Moderna Covid vaccine. I want to know if it's safe to get a third dose right now?). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I'm 36 weeks pregnant and have had both doses of the Moderna Covid vaccine. I want to know if it's safe to get a third dose right now?) outcome was unknown.     No concomitant medication information was provided.  No treatment medication information was provided.
After the 1st 24 hours from his shot, he was having  trouble breathing,  by the third day his skin color was looking grayish, but he thought this was all from him being recently diagnosed  with COPD. He did not show up for work on Friday and when his coworker went to his home to check on him and found him unresponsive, she called 911. They tried to revive him, but was unable to. I sadly have to report he passed away.
Rash/warm to touch 7 days post vaccine. 5 x 2 1/2 inch oval Right Deltoid.
This spontaneous report as received from a female consumer of unknown age reporting on herself. On an unknown date, the patient started therapy with DULERA (dose and indication not reported). Other suspect therapies included ZOSTAVAX received in November 2014, "the early part of last week". The patient reported that approximately on 08-NOV-2014, "past weekend", she experienced chest pain and went to the hospital (duration unknown). At the time of the report, the action taken with DULERA and the patient's outcome were unknown. Additional information is not expected. There is no contact information.
Per PCRS: Chief Complaint: Patient having rash, welting on upper portion of body, arms, buttocks. No shortness of breath, feeling in throat. Itching started last night on arms, but became worse at 04:00 am. Assessment/Plan: Allergic reaction likely on Flu vaccine; DEPOMEDROL 40mg IM now, add BENADRYL 25-50mg QID PRN. No more flu vaccine! To ER if sxs. worsens. Symptoms: Symptoms: 2. Urticarial Pruritus. Treatment Drug Used: 1 - Methylprednisolone Dose: 40 Units: MG Freq: ONCE Route: IM. 2 - Diphenhydramine Dose: 25 Units: MG Freq: PRN Route: PO.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 08Oct2021 as dose 2, single (Batch/Lot number: unknown) and on 10Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "allergic asthma since childhood" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2021, stop date: Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Was testing negative for 4 days then sick and testing positive again; Positive, notes: Was testing negative for 4 days then sick and testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 02Dec2022 to 07Dec2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Papular erythema rash. Left axilla, left elbow hands flushed.
Indurated red rash that started  around the patient?s left eye just over 24hr after the second vaccine dose. It progressed to an ulceration by the weekend (3-4 days post vaccine), then additional rashes developed on the cheek below it. Additional rashes developed on both arms which progress to bullae.
a patient was administered a dose of Pentacel on 6-Aug-2019 which was stored at minus 2.6 Celsius for one hour and four minutes, temperature excursion; Initial information and additional information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old patient age unknown was administered a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 6-aug-2019 which was stored at minus 2.6 Celsius for one hour and four minutes given in error lot number: lC5515AA and expiry date 15-Sep-2019 via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Received phone call from patient reporting c/o chest tightness, pain & blistering at injection site, shoulder pain and cotton mouth. She denied fever. Skin rash, rash & chest pressure. Acetaminophen/hydrocodone 1 tab TID, omeprazole 1 tab every day, prednisone 3 tab every day.
pt recv vax 13MAY94 & soreness recurred; No further details were provided;
I had a kind of an allergic reaction to it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a kind of an allergic reaction to it. Outcome of the event was unknown.  No follow-up attempts are needed. Information about Lot/Batch number cannot be requested.
Pt autoinoculated - locations 2cm below site of vaccine (on Left deltoid), as well as below chin. Currently each site (as well as vaccine site) has lesion with 40-50% scabbing. Pt noticed lesions 5 days ago.
1-21-21 @ 11  pm - chills started,with 98.7 F fever. Body aches and headache.  They continued all night and still going today 1-22-21 @ 5:08pm.   Temperature continues to go up it has not gone down from 102.5 F. In the past 2 hours after taking Tylenol at 3:30pm.   feels very thirsty, have  drank 4- 24oz of water, a bottle of 28oz Gatorade. Shortness of breath started 8:45 am 1-22-21 Fast heart rate and feels heart skip started around 3:30pm 1-22-21  took 500mg Tylenol at 3 am  Took 1000mg Tylenol at 7:30 am  Took  420 mg Naproxen @ 9:30 am  Took 1000 mg Tylenol @ 3:30pm
Swollen feet after nap. Hives on torso. Itchy. Irritable. He kept waking up. His lips were swollen on Thursday when he woke up. We went to clinic they just got his temperature and blood pressure, then sent us to urgent care then doctor prescribed prednisone for 5 days, topical cream and gave him half dose of BENADRYL.
Large, warm, red, raised, erythematous, indurated area around injection site.  Improved after 48 hours.
Patient A&Ox3. After patient received Pfizer 0.3mL COVID-19 vaccination on left deltoid, patient reported 7 minutes post vaccination, itchy burning on left eye spreading to right eye, minor headache. Patient denies SOB, chest pain, trouble breathing.  Upon assessment, noted of left deltoid was warmth, swelling, and redness. Swelling also noted on left eye with slight redness at conjunctiva   Patient was medicated with 50 mg benadryl right deltoid.
Gross hematuria on 20Jun2021. This occurred immediately after running ~ 5 miles. Unlikely to be related to vaccination as this AE was nearly 5 weeks after vaccination (10May2021). Reporting because an AE is an AE, not necessarily related to vaccination.
left arm stiffness, back stiffness, neck stiffness; decreased mobility in all four of his extremities; This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 4Z43X, expiry date unknown) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) (batch number DJ7721, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal stiffness (1st dose received on 16th September 2020, refer case US2021062762).   On 28th November 2020, the patient received the 2nd dose of Shingrix and PREVNAR 13. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced stiff neck and mobility decreased. Rechallenge with Shingrix was positive. On 1st March 2021, the outcome of the stiff neck and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the stiff neck and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in left deltoid and Prevenar in right deltoid and experienced injection site discomfort, mobility decreased. Neck, back and arm stiffness. The reporter stated that, mobility decreased improved on  27th February 2021 and 3rd March 2021. The reporter stated that, the events were resolved. The reporter consented to follow up. It was unknown if the reporter considered the injection site discomfort, stiff neck and mobility decreased to be related to Prevenar.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062762:same reporter
Patient previously tested positive on 8/13/22.   Patient was brought to local Hospital ED on 10/6 with unknown onset of shortness of breath and productive cough with yellow sputum. He also reported feeling "very very tired".  During this visit, CT scan showed concern for blood and blood clots in the pericardium, and the patient was found to have a systolic blood pressure in the 100s. Bedside ultrasound showed fluid around the heart.  He was given a unit of blood and started on Levophed, and was transferred to alternate Hospital ED. Within minutes of arrival, the patient became obtunded and unresponsive with shallow respirations. The provider was unable to palpate a pulse so CPR was started immediately. Patient was given multiple rounds of epinephrine, bicarb, calcium and volume resuscitation with IV fluid and packed red blood cells. The provider was concerned for aortic dissection or other catastrophic vascular cause for the patient's presentation. Further ultrasound revealed an apparent pleural effusion on the left.  Needle thoracostomy and tube thoracostomy was performed with a large volume of blood from the left hemithorax. Early in the resuscitation, ready pulses were felt with rhythm checks, however pulses were lost and were not regained. per the provider, given the prolonged downtime, likely catastrophic vascular event and the patient's advanced age, further resuscitation efforts appeared futile. Patient passed on 10/6 at 2:28pm.