chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a smallpox immunization and four days later developed another blister near the original blister and a pruritic rash in the left upper arm, left lateral chest, neck and penis.
Fever, chills, body ache, fatigue, and mild headache all lasting about 48hrs.
Headache x 4 days, chills/sweating. Pt stayed inside; took OTC medications.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 17-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable nurse at pediatric office received via a Pfizer sales representative. A 17 year-old male patient received the first dose of TRUMENBA on 14Aug2017, at 0.5 ml single, in left arm, for immunisation. Medical history included viral meningitis at the age of 4 and was hospitalized. Concomitant medications were none. On 14Aug2017, two hours after vaccination, the patient experienced chills, weakness, headache and sensitivity to noise. All the events lasted for about four hours and resolved on 14Aug2017. The patient had no residual effects. The reporter felt that during those four hours it was pretty serious, almost enough so that she was going to take him to the Emergency Room, but she did not. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
administration on May 18h 2021  of an expired dose/vaccine expired on March 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA321A, expiry date 30th March 2021) for prophylaxis.   On 18th May 2021, the patient received Menveo. On 18th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist called to report the administration of an expired dose of Menveo to the patient, the vaccine was expired on March 2021. No further events were reported. The reporter agreed to follow up from the safety team.
Hypotension 90/60 experienced; Dizziness; almost passed out; rapid heart beat and unable to breath
I started having severe headaches when I would bend over to pick up something off the floor, when I coughed and pushing to have a bowel moment.  I took OTC cold medications and that didn't do any good. It wasn't bad enough to go to the Urgent Care. July 5th Medicare checkup I told my Dr. about the headaches and he gave me a sedimentation rate blood test and it came back mildly elevated and gave me a course of antibiotics and prednisone. I completed both and the headaches had went away and not returned.
A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal) 0.2 Millilitres, Total. FLUMIST Quadrivalent (Intranasal) started on an unknown date. The reporter stated patient was administered expired dose which started on 13-Jan-2016. The outcome of the event of expired dose is unknown. The reporter's description of the event(s) was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious.
Patient given Moderna BV vaccine and Fluorix at approximately 5:13pm on 11/8/22. Patient initially "felt whoozy" and became unconscious in chair without any injury to himself while I kept him in his chair. Patients mother came over and said patients brother and father both have these occur after getting vaccines and rubbed patients head who woke up. Mother asked patient to stand and almost immediately after standing patient   fell back and all muscles became rigid and his body arched backwards, and his eyes rolled itno the back of his head and eyelids closed and all of these symptoms lasted for 10 seconds. Patients skin  turned white, and sweaty all over  which lasted approximately about 15 minutes. Patient did not have incontienence at any point. Patient did not experience postictal episode. After episode, patient placed supine for 15 minutes after, then sitting 15 minutes, then standing for 15 minutes. Post episode, patient alert and oriented times 3 and could talk without issue during episode. Vitaly stable throughout event with Blood pressure 110/70-75, HR 75-80, SpO2 99%.  Recommended transfer to emergency departmnet for higher level of care evaluation of Seizure like episode via ambulance transfer. Patietns parents declined ambulance and stated would drive patient to Emergency department (ED). I gave parents the "Medical Emergency Response form" for the ED and also called and notified the ED of the event.
Pt had shingles vaccine on 8/7/17. Next morning arm red, warm, and slightly swollen. Itching. Today arm is the same bright red, warm and rash. Not getting any worse. Cold compress to area and BENADRYL BID x 2 days. To call back if does not continue to improve.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 10-JAN-2020,  the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number  S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient has history of fainting with all vaccines. Once receiving vaccine, passed out for 10 seconds and regained consciousness. Vitals were monitored, patient was fine and left after 30mins
Severe body aches.  Fever up to 102F.  Chills.  Taking analgesics and antipyretics for symptom relief.
Patient received Quadracel vaccine only approved for use in ages 4+, no adverse reaction happened, patient tolerated.
Approx 6 days post vaccine, pt noted a small red rash on right arm. Reports rash "blistered and turned black". 2-3 days later a large eruption noted to right side of abdomen with a reaction to left arm at site of injection.
Extremely wet cold sweat that same night.  (Head drenched with sweat and very drowsy.)  Next day diarrhea.  Fussy and whiney for the following week and waking many times during the night.  Excessive abnormal drool for a week following shot.  A few days after shot developed a large pimple/bump on chin as well as bumpy rash on back of either arm which both lasted about 3 weeks.     (Other daughter received polio shot same day and she also had abnormal symptoms and behavior following shot which lead me to believe these symptoms/behaviors were related to shot.)
Patient received booster Pfizer dose. Vaccine not kept at correct temperature and needs to be repeated.
Post 2nd vax in series, pt experienced much worse fatigue than first, major loss of memory and concentration, feeling of drunkenness, lethargic, slurred speech, and loss of appetite. No mention of hair loss or joint pain as with first vax.
Experienced Fever, and body aches and pains.  Light Headache on day of vaccine.  A few days later I kept experiencing increasing arthritis related pain and pain in hands and joints (Right Hip, knees, hands).  I have experienced an increase in minor headaches that seem to come out of no where and last a few minutes before resolving.  My arthritis has gotten much worse on the constant pain level and my hands are experiencing more arthritis and grip related issues that appear to have been happening since my second dose of Pfizer vaccine.  I also experience what I call an "internal fever" that feels like I am very hot inside, but no external fever is present.  Family members have mentioned that my hands are very warm when I am experiencing the "internal fever".  Not exactly sure if this is all related to the vaccine, but I was not experiencing arthritis pain, issues with hands and joints, and "internal fever' and headaches prior to the vaccine.  I left it unreported for a period of time to see if it would resolve, but has not resolved as of yet.
Approximately eight (8) hours after the J&J vaccine was administered, the patient (me) experienced chills, low-grade fever(98-99) and generalized body aches.   400mg of OTC ibuprofen was taken an hour after these symptoms started.    Slight improvement of chills/aches.   Fever abated approx 10 hours later. However, at 4pm the next day (so ~22 hours after administration of vaccine) the same symptoms recurred.  They were less severe, and abated overnight, with a total of 600mg ibuprofen given in divided doses (200mg at 6pm and 400mg at 11pm).
06-25-10 Pt. presented to clinic with (R) thigh red, warm to touch area approx. 2 1/4" x 3 1/4". Consulted with NP. Verbal orders of MOTRIN 1/2 tsp q 6hrs prn. Warm compresses to area q 20 min. ER precautions given to parent. 06-28-2010 - TC spoke with mother, child better, area cleared over weekend.
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 26-JUL-2016 the patient was vaccinated with improperly stored VARIVAX (dosing details were not reported) (lot # 1035124, expiry date 14-SEP-2017). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Has not received 2nd dose; Arm pain; Shoulder blade catch sore muscle\ arm pain; Fatigue; Pain at injection site; Myocarditis; Shortness of breath; weakness; Chest pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included DULOXETINE, GLIMEPIRIDE, LISINOPRIL and METFORMIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ASTHENIA (weakness), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), PAIN (Arm pain), MYALGIA (Shoulder blade catch sore muscle\ arm pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 02-Apr-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), ASTHENIA (weakness), PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose), MYALGIA (Shoulder blade catch sore muscle\ arm pain) and FATIGUE (Fatigue) outcome was unknown and DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and PAIN (Arm pain) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No treatment information was provided. Patient stated that he thinks he may have had COVID in Dec2019 or Jan2020.  This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273  product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile.  Product dose omission is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added new event and updated vaccine dose information.; Sender's Comments: This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273  product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile.  Product dose omission is not applicable.
pt recv vax 19AUG98 & on 21AUG98 pt devel nausea, gen body swelling, body aches, malaise;sx persisted & was seen in urgent care facility on 22AUg98;dx has having allerg reaction to hep b vax;
Patient had immediate swelling to left hand (vaccine received in left arm). Bilateral grip strength equal, pulses equal bilaterally, ROM equal bilaterally. Patient is obese so it was difficult to detect swelling but her spouse stated her left hand "looked a little swollen." She was assessed by paramedics and given Benadryl 25 mg.
This spontaneous report as received on 09-MAR-2017 from a female medical assistant (MA), referring to a female patient of unknown age.  The patient's pertinent medical history, concomitant medications and drug allergies were not reported. The medical assistant reported that on an unknown date, the patient was administered a dose of improperly stored VARIVAX (Lot number M024702, expiration date 18-MAY-2018).  The strength, site and route of VARIVAX administration were not reported. The VARIVAX was exposed to temperature: 6 degrees F (Fahrenheit) to 14 degrees F (Fahrenheit) for a time frame of 13 hours.  There was no previous temperature excursion reported. The call was not because of a data logger. No adverse effect reported. There was no product quality complaint involved. On 09-MAR-2017, it was further specified by the medical assistant (primary reporter), that the doses (as reported), which were reported to have been administered to the patient in this case, were exposed to 15 hours in the 6 degrees F (Fahrenheit) to 14 degrees F (Fahrenheit), rather than the 13 hours she originally reported. No additional information was reported. Additional information has been requested.
Rash at in injection site; Pain (at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at in injection site) and VACCINATION SITE PAIN (Pain (at injection site)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at in injection site) and VACCINATION SITE PAIN (Pain (at injection site)). At the time of the report, VACCINATION SITE RASH (Rash at in injection site) and VACCINATION SITE PAIN (Pain (at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Facial numbing; This is a spontaneous report from a contactable consume reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE (dose 1) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient just got her first COVID vaccine shot. She experienced facial numbing and wanted to know if it is normal to experience this side effect. Event outcome was unknown.  Information on the lot/batch number has been requested.
Rec'd LAIV on 10/15/15, that ngiht developed fever 103, sore throat, body aches, headaches. Lasted 1-2 days.
Pt came into our pharmacy complaining of her arm still hurting after receiving vaccine more than 15 days ago.  The pt's right arm was red and irritated in a large 2 inch circle around her whole arm.  Pt complained of arm  itching, warm to touch, swollen and  inflamed.
covid vaccine breakthrough  dose 1 Moderna  1/23/21  029L20A dose 2 Moderna  2/20/21  024M20A dose 3 Moderna  10/9/21  026D21A
oThis spontaneous report was received from a medical assistant who also is a nurse practitioner referring to a 6 month old female patient. The patient's concurrent conditions included a G-tube for history of aspiration. None drug reactions/allergies was reported. On 03-JAN-2017, the patient was vaccinated with ROTATEQ (Lot number reported as M038209, expiration date 23-APR-2018) dose was not reported, orally, for prophylaxis. There was no concomitant medication reported. On an unspecified date in 2017, after the patient received the dose of ROTATEQ, the patient experienced choking, she gasped (dyspnoea) and possibly aspirated. The outcome of choking, aspiration and dyspnoea was reported as recovered/resolved, the patient was fine at the time of reporting. Product quality complaint (PQC) was not involved. The reporter did not assess the causal relationship between the adverse events and the vaccination with ROTATEQ. Upon internal review, chocking and aspiration were considered medically significant adverse events. Additional information has been requested.
Starting in the afternoon of 11/28/2022, I just started feeling very fatigued and malaise. Then, when I woke up the next day, I felt achy and tired but also felt like I was coming down with something. I took an at home COVID-19 test which was negative. That evening, I felt worse. Wednesday morning, 11/30/2022, I woke up feeling terrible, had a fever of 101 and had chills and felt super achy. I was coughing and had phlegm. I had chest congestion and I took an at home COVID-19 test that day which was positive. Due to my previous history of heart surgery, I wanted to get PAXLOVID for safety. So, I went to urgent care to get prescribed PAXLOVID. I started it that day. I felt a lot better the next day and I no longer had a fever. I continued to gradually get better day by day, The malaise and achy feeling were the symptoms that lingered the most. Then, I finished PAXLOVID on 12/04/2022 and honestly I felt 100% better at that point. On 12/07/2022, I started to feel congested again. Then, I continued having the cold symptoms through the weekend: runny nose and feeling a lot of phlegm in the back of my throat that I needed to clear. I felt malaise and achy again. Yesterday, 12/13/2022, I finally felt I was improving again. Today, I feel a little better but still have phlegm. Today would be the first day I have not taken a decongestant.
Small asthma episode; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Small asthma episode) 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 ASTHMA (Small asthma episode). The patient was treated with ALBUTEROL [SALBUTAMOL] for Asthma, at an unspecified dose and frequency. At the time of the report, ASTHMA (Small asthma episode) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Multiple DVTs is left arm axillary and basilic veins, multi clot pulmonary embolism in left lung and heart. Symptoms started as DVT pain in left fore arm early to mid 07/2021, shortness of breath started on 8/9/2021 and continued and worsened with left lung pain and right shoulder pain continuing and worsening, hospitalized on 8/20/2021 after CT showed multiple blood clots in the left lung with severe pain, hospitalized until 8/24/2021  still having symptoms of DVT after leaving hospital.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) outcome was unknown. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in freezer and refrigerator where temperature dropped to : Frozen Vaccine 47Minutes -13.79 C, Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses, Lot no 027B21A 100 doses, Lot no 030B21A 100 doses and Lot No 02B21A 140 doses. HCP stated that 63 doses were administered and she also received the dose.