chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse (R.N), referring to a patient of unknown age and gender. The patient´s medical history, historical drugs, concomitant therapies and current conditions were not reported. It was reported that, between 30-AUG-2017 and 01-SEP-2017, the patient received an improperly stored dose of PEDVAXHIB lot # N001348 with expiration date of 31-OCT-2019 (dosage schedule and route of administration were not reported) for prophylaxis. No adverse effects reported. The temperature excursion was 34.5°F for 14 hours and 42 minutes; however, there was no previous temperature excursion.
Administered Boostrix in left arm first, then Havrix in right arm, then Engerix-B in right arm approx. one inch from Havrix site of administration. When pushing the dose of Engerix-B patient started "it burns" and "i'm goind down". Patient then lost consciousness while sitting in the chair, eyes rolled up and shallow breathing. Within a minute or less patient awoke and stated "I passed out". Patient also stated that he had not eaten today. Got patient some patient some peanut butter crackers and sat with patient for about 15 minutes to be sure no further reaction occurred. Patient did not report any previous adverse reactions to any vaccines.
This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received PREVNAR 13; batch number unknown, intramuscular in right arm on 12Dec2018 at a single dose for immunization. Medical history was reported as none. Concomitant medication included Influenza Vaccine on 12Dec2018 for immunization. On 12Dec2018, the patient got the flu shot in his left arm and the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in his right arm which bled a lot. He was fine the first few weeks but on 01Jan2019, patient developed pain in his lower back, side and lateral muscles, across his shoulders and underneath his clavicle. The injection site was sore initially and the muscle pain from an unknown date was getting a little better. The patient has been feeling muscle weakness on an unknown date, and on 01Jan2019, pain emanating from the injection site down through his back and sides of his chest wall and his core and it seems to be coming from injection site of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot not the Flu shot, though it has been going on for several weeks now. The outcome of the events injection site was sore initially / pain emanating from the injection site down through his back and sides of his chest wall and his core was not recovered, while outcome of the events got the flu shot in his left arm and the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in his right arm which bled a lot, pain in his lower back, side and lateral muscles, across his shoulders and underneath his clavicle, and feeling muscle weakness was unknown.
My arm was sore the first couple of days and then it all subsided.  Then on 1/21/2021 the injection site sore when I woke up, was swollen, red, and I had an achy body/chills.   I took Tylenol for the achy body and that has helped, but the injection site on 1/22/2021 still is very sore, red, swollen, and it looks like I?m having a slight allergic reaction with hives around the injection site. Nothing major just unusual since after I got the vaccine the soreness only lasted a couple days, then it returned almost a week later more sore/red/swollen than when I first was vaccinated.
Hot flashes/Hot flashes like menopause; Sick; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes/Hot flashes like menopause) and ILLNESS (Sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 037K20A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Acid reflux (esophageal).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (Hot flashes/Hot flashes like menopause) and ILLNESS (Sick). At the time of the report, HOT FLUSH (Hot flashes/Hot flashes like menopause) had not resolved and ILLNESS (Sick) outcome was unknown.            Relevant concomitant medications included Acid reflux and Cholesterol medication.  Patient was sure that after the booster patient experienced these symptoms. Patient still has hot flashes couple of times a day (morning and several times in the evening).  No treatment information was provided.
Ringing in ears (Tinnitus) Dizziness (Vertigo) Hearing loss
Spontaneous abortion 3 months after AVA 1.  Fatigue and general aching of joints and muscles 7 months after AVA 1.
Information has been received from a physician concerning a 12 week old female with no medical history or allergies who was vaccinated with ROTATEQ 2 ML PO first dose on 25-FEB-2008. There was no concomitant medication. The physician reported that the patient received the first dose of ROTATEQ and three weeks later experienced diarrhoea and vomiting. The patient was seen in the office and was dehydrated. The patient was sent to the hospital for blood tests and was positive for rotavirus. The patient was hospitalized overnight. The physician reported that the patient is: "She's good today( 20-MAR-2008)" The patient sought medical attention. The physician reported that the rotavirus caused the hospitalization and was an other important medical event. Additional information has been requested.
Lightheaded, brain fog, spacing out on normal daily stuff. Heart palpitations. I scheduled to see my doctor the next day. She suggested to see my cardiologist to follow up.
First positive test was on 05May2022; First positive test was on 05May2022; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 66-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing), notes: Other medical history: Coronary artery disease. Concomitant medication(s) included: METFORMIN; ATORVASTATIN; CARVEDILOL; CLOPIDOGREL; FINASTERIDE; PERINDOPRIL. Past drug history included: Piroxicam, reaction(s): "Known allergies: piroxicam", notes: Known allergies: piroxicam. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05May2022, outcome "unknown", COVID-19 (medically significant) with onset 05May2022, outcome "not recovered" and all described as "First positive test was on 05May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) positive; (20May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: First positive test was on 05May. Started Paxlovid and completed it and felt better. Developed COVID symptoms again on 19May. Had another positive test on 20May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
No adverse event; Patient was administered with 4 days expired bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with 4 days expired bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with 4 days expired bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with 4 days expired bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with 4 days expired bivalent vaccine).    No concomitant medications were provided. It was reported that side effects were unknown. No treatment medication was provided.
back started hurting; could not stand up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "back started hurting"; DYSSTASIA (non-serious), outcome "unknown", described as "could not stand up". Additional information: The patient received the first Pfizer shot on Tuesday morning around 10 o'clock and around 4 o'clock in the afternoon, the patient's back started hurting and by evening and then the next day and Thursday the patient really could not stand up, the patient had to bend over from the waist in order to walk. The patient did not know if this could be a side effect from the shot or with age, did not know if he/she turned something or twisted something. The patient asked if he/she should get the second shot. The patient further stated, "Right, I just read this morning that if you have a strong reaction to the first shot. It could be you are symptomatic and did have COVID-19 and you might not need the second shot." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a 67 year old female with blood pressure high and allergy to ampicillin who on 15-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included blood pressure medication. The patient reported that after receiving zoster vaccine live (Oka/Merck), she experienced redness, hot feeling, swelling, and itching at the injection site. She said "it felt like a spider bite." At the time of the report, the patient had recovered after applying BENADRYL. The patient did not seek medical attention. No further information is available.
gums got really swollen; gums got itchy; gums felt like burning; Fatigue, tired; Headache; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired), HEADACHE (Headache) and VACCINATION SITE PAIN (pain at the injection site). On 21-Apr-2021, GINGIVAL OEDEMA (gums got really swollen), GINGIVAL PRURITUS (gums got itchy), GINGIVAL DISCOMFORT (gums felt like burning), FATIGUE (Fatigue, tired) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PAIN (pain at the injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications was reported. No treatment medications specified.  Treatment information was not provided.   This case was linked to MOD21-080267 (E2B Linked Report).; Sender's Comments:  MOD21-080267:
I know she got 3 shots one in each arm she is having the same reaction on both sides.  I am not sure which shot was in which arm but I know she received MMR IPV & CHICKENPOX.  The shot to the left arm is significantly worse than the right it?s a huge red rounds larger than a silver dollar in size hive it?s flaming hot to the touch and feels like there is a large hard ball underneath the skin.  My daughter has never had a reaction like this to her body when given a shot so this is scary.  She?s less than herself and very blah today not lots of energy and just feeling under the weather.  I expect her to maybe not be 100% but this seems a little unusual for her.  I know it?s not her Drs fault and I certainly don?t blame him I just want to make sure she will be ok because I?m worried especially since the other arm is starting to get red and irritated.
Information has been received from a nurse practitioner concerning a 17 year old female with penicillin allergy and allergy to erythromycin who on 10-JUL-2007, was vaccinated with Gardasil. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN). It was reported that 10 days after the patient received the second vaccination with Gardasil "they" went to the emergency room on 20-JULY-2007. The patient was treated at another physician's office (name of physician and date of visit unspecified) prior to the emergency room visit, but after vaccination with Gardasil for a sore/strept throat. The patient was  treated with clindamycin 600 mg three times a day. The patient was examined in the emergency room and found to be afebrile, with a Bartholin cyst, strep throat and lymphopathy in groin. The patient was examined in the office 3 days after the emergency room visit. The physician and the office in the case were not the office that administered the Gardasil. No other information was reported. Additional information has been requested.
Had immunization on 10-10-07 - noted redness, tenderness, and warm to touch on 10-11-07 - area around 2" long by 1" wide - adv cool compresses and Tylenol as needed to call MD is worse - left upperarm
after vaccination , patient felt she had bumps on her forhead, pt said she does not have any other problem , just bumps, so i gave her 2 benadryl with water, after that we watched her for any other sign, per pt she felt fine after benadryl, and bumps stopped , i called her on 04/27/21 followed up with pt ,m, per pt she had to take another benadryl at bedtime and she is doing ok now , i did call and left message at her drs office about the event
Tdap vaccine was given in upper left arm at end of physical on 08/09/2007. (Approx. 12:45pm)On August 6th I had a Tuberculosis test done, so the Dr. could read results at my appt. 8-9-07.On 8-10-07,The next day other than severe muscle pain in my left arm I developed a slight fewer of 100.2,which Tylenol did control for the next two days. My other symptoms include a sore throat (which I still have 8-13-07), and 2 days of major body aches. Left kidney area not feeling right. I felt/feel like someone having the flu.In all I am a very healthy person and seldom have problems or colds.
Kinrixwas given as a 3rd dose for Dtap and Polio (instead of 4th and 5th); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 04-MAY-2023, the patient received Kinrix. On 04-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrixwas given as a 3rd dose for Dtap and Polio (instead of 4th and 5th)). The outcome of the inappropriate schedule of vaccine administered 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: 11-MAY-2023 Licensed Practical Nurse (LPN) stated that, Kinrix was administered to the patient, but based on the patient's vaccine records, it was given as a 3rd dose for Dtap and Polio, instead of 4th and 5th.  The vaccine administration facility was the same as primary reporter. The Healthcare Professional (HCP) does not had the expiration date at time of call.  It was identified using the batch identifier. The reporter had consented to follow-up via postal. The patient was given Kinrix vaccine as a 3rd dose for Dtap and Polio, instead of 4th and 5th which had led to Inappropriate schedule of vaccine administered.
Employee received the Pfizer vaccine dose #1 on 09/09 at the campus vaccine event. The injection was in the left upper arm in deltoid. Started have symptoms after vaccination (09/10): Sore and redness at injection site and warm to touch, half dollars size knot on arm on side of injection site. She is 6 weeks pregnant as of 09/10/2021.  Advise to call back if symptoms worsen as follow up call, contact  PCP/OBGYN follow up if needed. As well to put cold compress on site and take ibuprofen or Tylenol, which one she is comfortable with taking due to her pregnancy.
BlurredVision & Myalgia Narrative:  blurred vision which resolved on its own and myalgias improved with tylenol.
Left arm swelled up/she experienced after receiving one of the first or second primary series / Inflammation; Left arm red up to elbow/she experienced after receiving one of the first or second primary series; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Left arm swelled up/she experienced after receiving one of the first or second primary series / Inflammation) and VACCINATION SITE ERYTHEMA (Left arm red up to elbow/she experienced after receiving one of the first or second primary series) in a 79-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Left arm swelled up/she experienced after receiving one of the first or second primary series / Inflammation) and VACCINATION SITE ERYTHEMA (Left arm red up to elbow/she experienced after receiving one of the first or second primary series). At the time of the report, VACCINATION SITE SWELLING (Left arm swelled up/she experienced after receiving one of the first or second primary series / Inflammation) and VACCINATION SITE ERYTHEMA (Left arm red up to elbow/she experienced after receiving one of the first or second primary series) had resolved.            No concomitant medication information reported. Treatment medication information reported as Antibiotic for inflammation.  Patient reported that the patient's doctor gave her an antibiotic to stop inflammation and it worked. Patient mentioned that patient will not receive another Moderna's covid-19 vaccine because of the side effects Patient experienced.   This case was linked to MOD-2022-541370 (Patient Link).
3 cc dose administered - drug error. 6 dose injection. Arm red, painful @ inj. site.
Between 1st and 2nd vaccine, shawl type rash occurred on shoulders. Severe hives then developed. Treated with multiple antihistamines by dermatologist, no positive response. Hives finally disappeared after injections of Xolair. Another rash was under the 'hives', determined after multiple blood tests and skin biopsies to be DERMATOMYOSITIS.  The severe muscle inflammation followed, with major lack of mobility, tingling in left hand from ulnar nerve compression, hair loss, etc Currently being treated by a group of medical personnel, with prednisone as well as additional medications, oxygen therapy as a bronchoscopy showed clotting, physical therapy to improve mobility,
Husband received Vaccinia vaccination on 20160111.  Wife may have been exposed to vaccination site.  Has 3 lesions consistent wife vaccinia inoculation.  One is very itchy.  (Statement provided by the Doctor).
Approximately 30 minutes after vaccine developed Tachycardia, Tachypnea, Fever, Chills, dyspnea, Wheezing
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Atorvastatin, clopidogrel, finasteride, Levothyroxine, pantoprazole, HUMIRA, metoprolol succinate, enalapril, PNEUMOVAX and tamsulosin. On 31st March 2018 11:00, the patient received the 1st dose of SHINGRIX. On 31st March 2018, less than a day after receiving SHINGRIX, the patient experienced chills and difficulty sleeping. On an unknown date, the patient experienced injection site swelling, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site erythema and chills were recovered/resolved and the outcome of the difficulty sleeping was unknown. The reporter considered the injection site swelling, injection site itching, injection site erythema and chills to be related to SHINGRIX. It was unknown if the reporter considered the difficulty sleeping to be related to SHINGRIX. Additional details were reported as follows: The patient stated half day after vaccination, the patient developed chills at night and was not able to sleep. Less than a month after vaccination, the patient stated the injection site was red, swollen, and itchy which lasted about approximately for a week. The patient gave the permission to contact their health care provider. The reported provided limited information in regards to lot number and expiration date of the product.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-01-27.
the next day p/vax arm became red & painful, swollen;applied ice & was started on keflex;
Left arm slightly heavy, pain around vaccinated area like the type of when doing arm weights (biceps). It is my first day, so it is not to visit a doctor. We'll see how it goes on June 29.