chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a severe overall body rash, it was all over my entire body; itching; sickly feeling from time to time; the levels of the eosinophils are suggesting an allergic reaction; the levels of the eosinophils are suggesting an allergic reaction; redness of rash; This is a spontaneous report from a contactable consumer or other non-health professional. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9264 and Expiration date: unknown), via an unspecified route of administration, on 17Feb2021 (at the age of 71-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included High cholesterol, High blood pressure, Artificial heart valve, Parkinson's disease from an unknown start date. The patient concomitant medications included Atorvastatin (40 mg) used for High cholesterol, Lisinopril (20 mg) taken for High blood pressure, Warfarin (5 mg) taken for Artificial heart valve and Carbidopa-levodopa (25-100) taken for Parkinson's disease and all from an unknown start date. The patient took number of medications for his maintenance that he had taken for number of years. On 26Feb2021, the patient stated that he developed a severe overall body rash, it was all over entire body and lasted. The redness of rash is just gone away, it's still itching in; sensations from it. The patient experienced Drug reaction, some itching, sickly feeling from time to time. The levels of the eosinophils are suggesting an allergic reaction. Consumer stated, "Well, I am calling to report a pretty severe reaction to the first Covid vaccine shot that I had, I had my first vaccine shot on 17Feb2021, approximately 3 weeks ago and about 8 days after the shot I developed a severe overall body rash, it was all over my entire body and lasted, the redness of rash is just gone away, it's still itching in, sensations from it, so it lasted about 10 days, so I am just reporting the reaction, I went to my dermatologist to look at it, and did a biopsy, and reported back this morning that the results of the biopsy indicated a drug reaction and I went to my internist who did some overall blood work and reported back this morning the levels of the eosinophils are suggesting an allergic reaction so I am just letting you know about it. Consumer stated, "I am experiencing some itching and some, what I call sickly feeling from time to time the redness is finally gone away, but it took it about 10 days to go away the redness but I still have some itching." Lab test: Consumer stated, "Yes, I have them right here they are quite expensive, it is comprehensive metabolic panel, I mean there are 15 different results, I don't want to go all over them."(Further name and result was not confirmed hence not captured in tab and yes was checked in tab). There was no treatment received. Outcome of the event redness of rash was recovered on an unspecified date in Mar2021, event Blood eosinophils abnormal, allergic reaction, rash was unknown and the events feeling sick, Itching are not recovered. No follow-up attempts are possible. No further information is expected.
Case previously recorded as MA2009-4324. Initial case report received from a health care professional via agency, on 16 NOV 2009. An 18 year-old male patient was vaccinated with 0.5 mL of FLUVIRIN (batch no. 102040P1) i.m on 16 NOV 2009. After vaccination, it was noticed that the patient already received FLUVIRIN in a nasal form in a couple of weeks ago. No adverse event were reported. Agency reference no.: NA09-008278.
Injection site area is very itchy; Nausea; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE PRURITUS (Injection site area is very itchy) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Dairy intolerance, Egg allergy, Allergy to grains (Wheat), Food allergy (beef,xanthan gums, guar gums (thickeners)), Anesthesia general, Allergy to antibiotic (Levaquin), Drug allergy (all aspirin family), Drug allergy (Valtrex), Drug allergy (Lamisil), Drug allergy (Mortin), Drug allergy (Advil), Drug allergy (Vanceril), Drug allergy (Xloft) and Drug allergy (Prednizone). Concomitant products included BETA CAROTENE, BIOTIN, UBIDECARENONE (COQ10 [UBIDECARENONE]), GLUCOSAMINE & CHONDORITIN, MULTIVITAMIN [VITAMINS NOS], LUTEIN [XANTOFYL], VITAMIN B12 [VITAMIN B12 NOS], ASCORBIC ACID (VIT-C), VITAMIN D3 and VITAMIN E NOS for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm) and NAUSEA (Nausea). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site area is very itchy). At the time of the report, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE PRURITUS (Injection site area is very itchy) and NAUSEA (Nausea) had resolved.            Other concomitant medication included blilberry.  No treatment was received by patient.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow-up information received on  24-May-2021 contains reporters address and email ID On 04-Aug-2021: Patient demographics added, allergies updated. Suspect dose information, event outcome  and Concomitants updated.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
12/09/2021 vaccination; 12/10/2021 I woke up, I felt achy, little HA. Took Tylenol. Arm was sore that afternoon. Raspy throat that Sunday, slight temp. By Wednesday, I did not feel well; Bad HA, slight tempy, raspy voice, coughing, nasal drip. I called PCM; put on zpack, 2 nasal sprays. Decided to have COVID test that Wednesday; positive. *6 days after booster tested positive *residual raspy throat.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improeprly stored GARDASIL (dose, lot # and route of administration were not reported). Patients were also vaccinated with improperly stored Tetanus-Diphtheria vaccine (TD). No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  Swollen red itchy rash approximately 3" below injection site  After 1st dose it was discovered approximately 7-10 after vaccine After 2nd dose it was within the same day
Started having uncontrollable chills and shaking.  Put on 3 blankets.  It lasted for 1 1/2 hours before finally subsiding.  My body felt like it was burning up to the touch but I was too sick to get a thermometer.  I then started to get dry heaves and felt like I was going to pass out.  Had difficulty walking from room to bathroom.  Was weak, dizzy and felt generally horrible for all of next day.  Have slept almost non stop until now.  Had no desire to eat anything.  I have had the regular flu shot for 11 years and never had any kind of reaction.  This high dose vaccine that they gave me really made me feel awful and symptoms were bad.  I will not take the high dose vaccine again.
Redness, swelling (softball-sized), hot to the touch, itching, pain, skin is very hard, gravely skin texture
rash that has become increasingly worse, spreading all over her body/rash feels like poison ivy and looks very prickly and itchy; rash feels like poison ivy and looks very prickly and itchy; rash is like poison ivy all over her body and it is very uncomfortable; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101689900 (Pfizer).  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: EW0196) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, LOT: EN6203, Route, Anatomical Location: left arm), administration date: 02Mar2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, LOT: EP6955, around 3:00pm, Route, Anatomical Location: left arm), administration date: 27Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash that has become increasingly worse, spreading all over her body/rash feels like poison ivy and looks very prickly and itchy"; RASH PRURITIC (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash feels like poison ivy and looks very prickly and itchy"; DISCOMFORT (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash is like poison ivy all over her body and it is very uncomfortable"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of rash, rash pruritic, discomfort.  Additional information: The caller stated that the rash had gotten worse with a mighty force and states that it feels like poison ivy and looks very prickly and itchy. It started on the inside of the right arm, which was the opposite of the left arm, which she got the shot it. The rash started on the left arm and was spreading everywhere, all over her body, with a vengeance. It was like poison ivy all over her body and it was very uncomfortable. She has tried Cortisone cream and tried taking Benadryl. Because Benadryl was an antihistamine, she thought it should calm things down. It did for a little bit but, not enough to stop it. She was having to take it every 3 or 4 hours.
03/28/03 at 9AM:  Patient reported headaches, body aches, difficulty catching breath.  Symptoms worsened throughout the day with patient having severe headache not relieved by ibuprofen by 2pm.  At 1800 hours, patient reported to ER at work with complaint of headache , body aches, moments of confusion, dyspnea, extreme SOB, nausea without vomiting, blurred vision.  CT of head normal; LP - CSF clear, viral load high.  Patient treated with phenergan, toraDOL, demerol, albuterol.  Patient released from ER and recovered over weekend. Returned to work Monday, 03/31/03.
redness, hardness at injection site w pain. sweating, headache, chills, back pain, decreased appetite, lightheadedness, malodorous urine, fever, fatigue
Vision went blurry and couldnt see well for about 30 minutes; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 02Sep2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 02Sep2021 at 12:00, after about an hour after getting the shot, the patient's vision went blurry and could not see well for about 30 minutes. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event vision went blurry and couldn't see well for about 30 minutes was resolved on 02Sep2021 at 12:30.
Kinrix was expired on May 7th 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 22-MAY-2023, the patient received Kinrix. On 22-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix was expired on May 7th 2023). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter was medical assistant. The reporter consented to follow up via email. The patient received an expired dose of Kinrix, which led to expired vaccine used. The case had been linked to US2023072490, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023072490:Linked case for twin's patient
Fever; Muscle Pain; Chills; Diarrhea; Heart Palpitations; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 15:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included dysautonomia, A-flutter, depression, anorexia nervosa, gastroesophageal reflux disease (GERD), hypothyroidism and known allergies to shellfish, latex and adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 15:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021, the patient experienced fever, muscle pain, chills, diarrhea, heart palpitations and weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, muscle pain, chills, diarrhea, heart palpitations and weakness was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
No immediate side effects after shot.  8 hours after shot, had fever that reached 103 degrees F, with chills and nausea.  Felt "cloudy" in thoughts and couldn't focus or complete any tasks.  Was not able to sleep at all that night.  Around 8 AM the following day the fever reduced to 101, but cough started and felt fatigued.  Fever dropped to 99 by the evening, but cough and fatigue persisted.  Fever completely gone on Friday 3/12/21, but cough and fatigue are still present as of 3/15/21.  Current cough is inconsistent (few times an hour) and fatigue is better than previous but still present.
Client is a 11 year old female that presented to the immunization clinic for Tdap, HPV9, and MCV4 vaccine. Client was called back to vaccination area around 0930. Client reported no vasovagal hx-confirmed w/ mother. This writer administered Tdap vaccine & client began to lean over in chair. This writer & mother supported client. Client reported feeling "nauseous & tired." This writer explained to client that she had experienced a vasovagal reaction. Client was able to tell this writer name, DOB, and location. This writer asked co workers for assistance. Co-worker obtained ice pack for client because she reported feeling hot. This writer obtained trash can (reported feeling nauseous) & began to fan the client. This writer noted client's lips/ skin were pale. Client reported eating & drinking this morning prior to appointment. Client reported feeling "slightly better." Client was transported to bed in clinic area by nursing staff (co-workers & this writer). Client was provided water & saltine crackers. Client was encouraged to raise legs to increase blood flow. This writer noted client's lips/skin returned to normal color. Client reported feeling better & stated "I am ready for the next vaccines." This writer explained that client would need to remain lying down for next two injections. Client and mother verbalized understanding. This writer administered MCV4 & HPV9 with no issues. Client was encouraged to stay lying down for 15 minute wait. Client waited 15 minutes & reported feeling "good." Client & mother were observed walking out of clinic @ 1015. This writer encouraged mother to inform future vaccinators of vasovagal hx of client, so vaccines can be given lying down.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 10:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.65  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09,10,11 AM, 2,3 PM temperature was 32,32,32,35,35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
I had a cough, congestion, sneezing, runny nose, muscle aches and pains, slight head, like I had a regular cold. I would not have tested if someone had not called that I had been in contact with that tested positive. I took a home COVID-19 test, it came back positive. I called and had a telehealth visit with my primary care physician. Since I had already taken PAXLOVID in July we decided I did not to take it again. I am finally better with the exception of the fatigue.
103 fever, swollen lymph nodes in breast and under arms for about 4 weeks.
Pt vax 3 doses;  was found to be a non responder.  Booster dose was given.
I got J&J. Pre covid vaccine I was hiking and backpacking at high altitudes (above 6000) with no issues.  Male age 65.  The day I got the J&J vaccine, 4 hours later I was sick in bed with moderate flu-like symptoms. It took the better part of 2 days before I felt normal again. My partner also got J&J at the same time and had no apparent symptoms.  Three months later, I could not walk 100 feet without having to sit down. My PsO2 (blood oxygen level measured with a fingertip meter) was, sometimes, in the mid 80% range (normal should be 98%-100% and my girlfriend was in that range) and my rest pulse was 130-160.  I felt like I was running maximum effort on the track, but doing nothing.  After a few weeks out there, we attempted a repeat of a backpacking trip that we had done in 2018. At 12000 ft along the continental divide, I could not average 1 MPH hiking whereas 3 years prior we were hiking at 2-3 MPH. After most of a day of hiking only 3 miles, we abandoned the trip.    I notice the shortness of breath.  I have run over 50 marathons (PR 3:29) so I know what is normal. I have seen pretty much every specialist there is and all the testing (blood work, multiple stress tests, pulmonary function tests, CAT scans) says I am normal.  This condition is NOT normal for ME.  The report from my Pulmonologist last week (05/2022) basically said don't bother us until it gets a lot worse.  I was very active pre-vaccine and this onset was sudden.  Here is a list of my trips before and after.  I had no breathing issues pre 03/2021 vaccine and had issues every trip afterward. Date                Event Type 2018-Jul-01 Hike 2018-jul-17 Backpack 2019-Aug-06 Backpack 2019-Oct-11 Hike 2020-Jan-23 Hike 2020-Oct-11 Hike 2021-Mar-11 COVID-19  J&J Vaccine Vaccine 2021-Jun-24 backpack 2021-Jun-29 Hike 2021-Jul-08 Hike 2021-Oct           Hike  2021-Nov-12 COVID - Moderna half dose booster Vaccine
Dizziness, Headache, Fever, ErythemaMultiform, back pain, golf-ball sized lump at injection site, fatigue. Symptoms lasted 3 days Narrative: