chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent cough and fatigue so I went to Allergist and he prescribed Flovent. I still have shortage of breath with intense exercising. I was informed this may solve itself in time so I will be monitored.
Patient did not experience an adverse reaction to the Pfizer vaccination. Patient was given the wrong dosage. Patient received a multi vial dose containing 6 vaccinations that were intended to be given to six people. The vials were in a ziplok bag marked 10 single dose vials. The phlebotomist drew up the entire vial and gave it to the patient not realizing it was a multi dose vial. The other team member reviewing the 5 rights also did not realize it was a multi dose vial. Another team member went to draw up a pfizer vaccine for another patient and realized it was too much vaccine to be a single dose and reported it to the Clinical Lead. The Clinical Lead notified, Clinical Services Manager who driected the Clinical Lead to notify the patient's physician. Dr. directed the Clinical Lead to contact Poison Control who directed the Clinical Lead to review the Fact Sheet (in the vaccine box) or Scan the code to contact Pfizer. The Clincial Lead call and spoke with staff at Pfizer who took all the patient demographics and what occurred. The Clinical Lead was then referred to staff at Pfizer who looked up the possible effects which could be pain in the injection site, headache, muscle pain.  The patient was contacted and explained what had taken place and the patient states she felt good and had no side effects at that time and she was at work. Patient was told if she developed chest pain or shortness of breath to go directly to the Emergency Department. The Clincial Lead then contacted Dr. and notified him of the same. Patient  was contacted again the morning and stated she slept good, felt good. no soreness in the injection site. No headache. No fever. She had a little redness at the injection site and her stomach was queezy this morning. Patient states she sometimes has stomach issues and did not feel it is related to the shot. The Clinical Lead also stated due to the timeframe that had elapsed, she also did not feel the queeziness was not related to the vaccine.  The Clinical Lead then notified Clinical Services Manager to update her on the situation.  Also, notified Dr. of the patient's status.
Swelling, pain, itching, redness at the injection site. Low grade fever of 101. Naprosyn prescribed and cold compresses.
9/24/20 Rec'd flu vaccine 36 hrs after red/swollen/warm (started about 24 hrs after shot) abx for ? cellulitis
Vasovagal, no treatment. From the time I got the 4 vaccines, I have passed out over 100 times through out my life. Most of the time, it has happened at doctors offices. It has also happened at home and in the car. Many doctors can vouch for this.
Information has been received from a registered nurse referring to a patient of unknown age and gender. In approximately 2014 (reported as 1 and a half to 2 years ago), the patient was administered a dose of GARDASIL (lot#, expiration date, dose and route were unknown). In February 2016 (reported as sometime last week), the patient was vaccinated with a dose of GARDASIL 9 (route, lot#, expiration date and dose were unknown) at an unspecified physician's office (interchange of vaccine products and inappropriate schedule of drug administration). No adverse effects were reported. Additional information is not expected as the reporter didn't like to be contacted.
Patient stated that around 7pm the next day she started to experience congestion, chest tightness. After a couple of day feeling went away.
Lightheaded, tight chest. BPs 142/92 (pulse 74), 146/101 (pulse 75).
Drug ineffective; 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 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic esophagitis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Drug allergy"; Hydrocodone, reaction(s): "Drug allergy". The following information was reported: COVID-19 (medically significant) with onset 22Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 22Mar2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive; (27Mar2023) Negative; (01Apr2023) Positive; (05Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid from 22Mar2023 till 27Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146806 same patient different drug/events.;
Patient with complaints of "throat tightening" approximately 15 minutes after receiving HAVRIX. Mom provided pt. with BENADRYL and took pt. to emergency room. ER provided care for allergic reaction and discharged to home in stable condition.
Pain in (R) shoulder when sleeping and when it is moved certain ways. 11/13 went to doctor - shoulder inflammed. Pain began the day following the vaccine and continue to this date.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, outcome "recovered" and all described as "Covid-19". The event "covid-19" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient went to doctor and was given 5 days 6 pills a day of Paxlovid from 20Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Dose mistakenly given outside age recommendations.  Patient requested vaccine.   No adverse side effects reported.  Tolerated well.
p/vax pt became pale, nauseated, h/a, shaking, felt very hot to touch;no temp taken;
had a faint; felt a pain in his heart; vision blurred.; swollen; It's like a rash or allergy/ bumps are on the back of my head and ears, in the right arm and above the waist; little bumps in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (had a faint) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen), RASH (It's like a rash or allergy/ bumps are on the back of my head and ears, in the right arm and above the waist) and VACCINATION SITE RASH (little bumps in the injection arm). On 15-May-2021, the patient experienced SYNCOPE (had a faint) (seriousness criterion medically significant), CHEST PAIN (felt a pain in his heart) and VISION BLURRED (vision blurred.). On 14-May-2021, RASH (It's like a rash or allergy/ bumps are on the back of my head and ears, in the right arm and above the waist) had resolved. At the time of the report, SYNCOPE (had a faint), CHEST PAIN (felt a pain in his heart), VISION BLURRED (vision blurred.), PERIPHERAL SWELLING (swollen) and VACCINATION SITE RASH (little bumps in the injection arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Heart rate: "heart rate went up until 202-202 (while running)". On 15-May-2021, Heart rate: when he moves his heart accelerates.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 17-MAY-2021 patient went to ER, there they did a check and everything went normal. The patient said that while he he was at rest he was all normal but when he moved his heart accelerates (he felt a big difference). The patient mentioned that the previous allergy went away a week ago.  Treatment medication included cortisone cream.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Vaccination site rash and rash are consistent with the product known safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY 2021 contains vaccine details and  newadverse event updated as syncope, chest pain and vision blurred. Outcome of the event rash was updated as resolved. On 21-May-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Vaccination site rash and rash are consistent with the product known safety profile.
can still see tiny scabs; (left lymph node under his jaw) sore; 9 or 10 itchy bumps; including 2 or 3 itchy bumps on left lower back; Pain at the injection site; Felt a little bit of bruise; Slightly swollen; red; very sore for next two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MULTIVITAMINS & MINERALS PLUS LUTEIN and FISH OIL for an unknown indication.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days). On 26-Apr-2021, the patient experienced RASH PRURITIC (9 or 10 itchy bumps) and RASH PRURITIC (including 2 or 3 itchy bumps on left lower back). On 03-May-2021, the patient experienced LYMPH NODE PAIN ((left lymph node under his jaw) sore). On 05-May-2021, the patient experienced SCAB (can still see tiny scabs). On 27-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days) had resolved. On 05-May-2021, RASH PRURITIC (9 or 10 itchy bumps), RASH PRURITIC (including 2 or 3 itchy bumps on left lower back) and LYMPH NODE PAIN ((left lymph node under his jaw) sore) had resolved. At the time of the report, SCAB (can still see tiny scabs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
arm pain(on a (1-10) pain  scale I give it a 9)  , shivering, fever, chills, severe vomiting, was in bed for 4 days.  Missed three days of work.
note time of vaccination unknown Morning of 4/18 after up for a few hours noted "humming sensation" "internally shaking" mostly on left side - shoulder, chest, abdomen - less in leg.   She didn't think these were palpatations.   This symptom decreased some over time but still present today.  Afternoon 4/18 - left arm felt "tired" ? weak for about 3 days - resolved before I saw her in clinic on 4/22
This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received, when she was 68 year old, a single dose of PREVNAR 13, (Lot: L87117, Exp: Feb2017) IM on right deltoid on 15Sep2015 at midday to prevent pneumonia. Medical history included blood pressure and abnormal cholesterol. The patient never had a seizure disorder for which she was on seizure medications, a brain disorder, Guillain-Barre syndrome. She was not pregnant or considering becoming pregnant in the next month. Concomitant medication included hydrochlorothiazide/ lisinopril (12.5mg/ 20mg) tablet, started in 2010 and ongoing for blood pressure 1 DF 1x/day oral, NEXIUM 24HR 20 mg for long time and stopped in Spring 2016 and simvastatin started in 2009 and ongoing for cholesterol at 20mg (one tablet) 1x/day oral, FLUZONE HIGH-DOSE, (SANOFI, Lot: UL436AA, Exp: 08Apr2016, NDC: 49781-397-88) IM in left deltoid on 15Sep2015 for immunization. She also took a multivitamin and supplements. She experienced allergy to Codeine. The patient never had a reaction after receiving an immunization. The patient experienced pneumonia in Dec2015 and went to urgent care. Patient was not admitted to hospital. She received antibiotic treatment. The outcome of the event was recovered. Follow-up (04Oct2016): New information report from a contactable consumer included: concomitants data; no hospitalization; suspect and conmed details; medical history; past drug history; course of events.
Patient described the event:  the next morning and all day on the 17th not being able to move or eat.  Bedridden in body pain for the whole day, says she couldn't even feed herself.  She also threw up.  She had to have her son help her out by feeding her.  Then after a day some of  her strength returned, but entire right arm is still terribly sore 5 days later.
Felt cold; Body hurt; Shivering; Nauseated; A little fever of 100.3°F; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering) and NAUSEA (Nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 02-Feb-2021, the patient experienced FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering), NAUSEA (Nauseated) and PYREXIA (A little fever of 100.3°F). At the time of the report, PAIN IN EXTREMITY (Arm sore), FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering), NAUSEA (Nauseated) and PYREXIA (A little fever of 100.3°F) 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.   Treatment included unknown medication for nausea.
DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVELING; This spontaneous case report (PVX2019-2955) was received from a consumer on 02-Dec-2019. It described a female consumer who "did not complete immunization one week prior to traveling" (PT: Inappropriate schedule of product administration), while being on oral Vivotif (lot number: 3003277) for typhoid fever.  Case report: The consumer took first dose of Vivotif two days before reporting. She would be traveling to the endemic area before completing Vivotif and would be taking the last dose of Vivotif on the flight to the endemic area.  The action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of reported event was unknown.  Company Comment: A consumer did not complete four doses of Vivotif one week prior to traveling to endemic area (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer did not complete four doses of Vivotif one week prior to traveling to endemic area (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Localized swelling at injection site. Applied ice pack at site and patient was dispensed Benadryl v25mg and advised to take 2 capsules once arriving home.
It took my Photo Sensitivity to a much higher level . It does not seem to be getting any better .
Labored breathing started when doing minor to moderate physical activity after one month after my 2nd moderna vaccine shot. In addition, occasionally, at rest I had the need to take very deep breaths as if I needed more oxygen. Saw my GP on 5/3/21, did an EKG which was normal. Referred to cardiologist and pulmonologist for further testing. Whore a heart monitor for 30 days from 7/2/21 to 7/31/21.  All testing done is included below. No treatment provided.   As of 8/6/21, Over time breathing has been returning to normal over the past several weeks. Only occasionally do I feel the need to take deeper breaths which I hope will further decrease over time.
11/9/21 presents to EC ED "reports left sided chest pain and SOB". PMH "A fib on coumadin, CHF, CKD, CAD, CVA, GERD, HTN, hx of NHL, pulmonary HTN".
Fever, chills, joint pain 12-24 hours Nausea lack of appetite 2 days Lethargy 3 days
Narrative:  COVID infection following COVID vaccine series 01/11, Moderna , dose #1 02/08 Moderna , dose #2 09/09 pt cc: fatigue, myalgias, exposure: unknown 09/13 SARS-COV-2 Variant Sequencing: pending 09/13 COVID swab, result: detected 09/20 OVID swab, result: NOT detected
Eye roll, affect change, stopped smiling, laughing etc. Saw it again the following Thursday in increased amounts all day went to pediatrician. Friday November 19, 2010 went to Hospital. Admitted with seizures.
This spontaneous report as received from a medical assistant refers to a 2 months old male patient. The patient was vaccinated with the first dose of live, oral ROTATEQ(lot# unspecified). 0.2ml orally on 31-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. On 31-JAN-2013, after administration, the infant regurgitated the dose. No treatment was reported. The outcome of the event was unknown. Additional information has been requested.
Bumps all over body; Rash and itching all over body,legs, face and ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN SWELLING (Bumps all over body) and RASH PRURITIC (Rash and itching all over body,legs, face and ears) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced SKIN SWELLING (Bumps all over body) and RASH PRURITIC (Rash and itching all over body,legs, face and ears). The patient was treated with CORTISONE at a dose of unknown; ISOPROPANOL (RUBBING ALCOHOL) at a dose of unknwon and PARACETAMOL (TYLENOL) at a dose of unknown. On 27-Jan-2021, SKIN SWELLING (Bumps all over body) and RASH PRURITIC (Rash and itching all over body,legs, face and ears) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt presented on 5/9/22 with rash to torso, face, trunk, plantar surface. Started on 5/9/22 am, on trunk that spread. Not painful nor itchy. Rash blanches with pressure;  maculopapular lesions with lighter halo, different sizes. No vesicular lesions.
Headache lasting 2 days, fever reaching 100.3 lasting 1 day, chills, body aches.
I started to experience really gradual itching all over my body so I started to take Zyrtec. As the days went on it started to progress and now I have welts and raised areas all over the body that are hot to touch. On 05/05/2022 I went to the dermatologist and was diagnosed with Dermatographia and was told that it was related to the booster vaccine. I was prescribed prednisone and told to continue to take the Zyrtec. It is slowly getting better, but it has not gone away my ears are hot and red. I use  lotion to help relieve some of the itch and the heat of my skin. Sometimes I cant even get in a comfortable sleeping position due to the itching and that has really caused me to have sleepless nights. I have psychological problems do to the way I look with the welts and the redness. I wonder if it can do this to my skin is it affecting my organs.
About 12 hours after I received the second dose of the covid vaccine, I started to get severe chills and headache followed by fever that lasted all night and was up to 101.4 F.  The fever improved this morning around 9 am, however I continued to have headache, myalgia, and fatigue all day.  I also have intermittent nausea and difficulty standing or walking around because of feeling like I will pass out.  I feel slightly improved tonight but still not normal.  I called the employee health this morning to inform them.
This spontaneous report as received from a certified medical assistant refers to a 7 month old male patient. Medical history and concurrent conditions were not provided. On 31-MAR-2015 reported as "today", the patient was vaccinated with a expired second dose of ROTATEQ oral by mouth, 2 ml, lot number J012522, expiry date 31-JAN-2015. No adverse effects reported at this time. There was no concomitant medication provided. Additional information has been requested.
On 2/28/21 a used vial of Pfizer vaccine was reconstituted again with sodium chloride, they were reconstituted in error and patient received diluent only immunization. The immunization administered that day was not effective in providing protection against COVID.   Patient did not have any adverse reaction to the sodium chloride and refused to be revaccinated.