chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a 18 year old patient of unknown gender. The patient's  medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received form the same reporter. Additional information has been requested.
About sixteen hrs after vaccine given I developed severe muscular aches and chills, shivering, and a sore L arm where I was vaccinated. The upper deltoid where my vaccine was given became very red and sore as well, but has since resolved. Advil 200mg two tabs every six hrs were taken the day I started initially having symptoms and helped a little. The chills were on and off over the past 10 days , continued daily and I felt like I was coming down with the flu but never ran a fever. The highest my temp has been was 99.6 F. I have never felt like I was "burning up" as with flu in the past.  I began to feel very weak four days  post vaccine and now eleven days post vaccine I am continuing to feel weak, anxious as I am worried about the adverse effects, and the chills are still occurring about every four hrs lasting about an hour. I also have had an upset stomach with loose stools starting five days post vaccine. Unsure if related to vaccine or not. I have reported my symptoms to my physician who did not feel necessary to be seen. He said he is unfamiliar with the side effects of SHINGRIX. I had the vaccine administered by a pharmacist who was very nice and stated he wanted to make sure he gave the vaccine high enough in the deltoid muscle. My arm redness and swelling completely resided. I am concerned as I still have weakness and chills, and mild loss of appetite. I have also reported these side effects to Glaxo SK. I repeated a call to my doctor today who has told me to go to the ER if I get any worse. He was not able to see me today as he is fully booked. I am going to continue to monitor my symptoms, and if I develop a fever, rash or any new symptoms I will be calling my doctor again.
pt recv vax 5OCT96 & 15OCT96 pt devel a chicken pox like rash w/9 lesions that had very large (giant) clear vesicles, generalized;
none, 5 year old given the 6 months to 4 year old mRNA 3mcg/0.2 dose
BLOOD PRESSURE INCREASED; BURNING LIVER; EXACERBATION OF REFLUX; SHARP PAIN IN STOMACH; FELT LIKE KIDNEYS WERE BURNING; SHARP PAIN IN CHEST; FELT THE VACCINE GO TO HEAD 10 MINUTES AFTER GETTING SHOT; RIGHT SHOULDER THROBBING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, alcohol use, non-smoker, and hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 14:10 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 144/80 mmHg. On 18-JUN-2021, the subject experienced felt the vaccine go to head 10 minutes after getting shot. On 18-JUN-2021, the subject experienced right shoulder throbbing. On 19-JUN-2021, the subject experienced sharp pain in chest. On 19-JUN-2021, the subject experienced sharp pain in stomach. On 19-JUN-2021, the subject experienced felt like kidneys were burning. On 19-JUN-2021, the subject experienced exacerbation of reflux. On 19-JUL-2021, the subject experienced burning liver. On 20-JUL-2021, the subject experienced blood pressure increased. Laboratory data included: Blood pressure (NR: not provided) 165/105 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 100/70 mmHg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in chest, sharp pain in stomach, felt like kidneys were burning, felt the vaccine go to head 10 minutes after getting shot, and right shoulder throbbing on 21-JUN-2021, and burning liver on 21-JUL-2021, was recovering from exacerbation of reflux, and the outcome of blood pressure increased was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
painful swollen lymph node(s) in my right arm pit; painful swollen lymph node(s) in my right arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Apr2021 12:00 (Lot number: ER8735) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Known allergies: bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 04Apr2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 26Apr2021, outcome "recovered" (Apr2021) and all described as "painful swollen lymph node(s) in my right arm pit". The event "painful swollen lymph node(s) in my right arm pit" and "painful swollen lymph node(s) in my right arm pit" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and receive vitamins, supplements within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Left deltoid area hot, red swollen. Left upper arm erythema, swollen, warm, tender to touch, with blisters.
onset of tiredness 3JUN97 in PM;by AM on 4JUN97 pt c/o nausea, gen weakness;taken home from school 1PM 4JUN-later had vomiting, diarrhea, lt arm soreness;fever 99.8 on 4JUN97;remains tired;
Sore arm. For the past 48 hours, headache, body aches, nausea, fever, sweating.
adverse events he is having after a week of having gotten his first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse events he is having after a week of having gotten his first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse events he is having after a week of having gotten his first dose). At the time of the report, VACCINATION COMPLICATION (adverse events he is having after a week of having gotten his first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Post vax, the patient developed a hard marble sized knot at the injection site, which was reddened 3cm x 3cm, and warm to the touch.
muscle cramps all over my body; my vision is blurry; my energy level is way down.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jul2021 13:00 (Lot number: fA7485) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0180, Location of injection: Arm Left), administration date: 11Jun2021, when the patient was 62 years old, for COVID-19 immunization.  The following information was reported: MUSCLE SPASMS (non-serious) with onset 23Jul2021 04:00, outcome "not recovered", described as "muscle cramps all over my body"; VISION BLURRED (non-serious) with onset 23Jul2021 04:00, outcome "not recovered", described as "my vision is blurry"; ASTHENIA (non-serious) with onset 23Jul2021 04:00, outcome "not recovered", described as "my energy level is way down.". The event "muscle cramps all over my body" was evaluated at the physician office visit. The events "my vision is blurry" and "my energy level is way down." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, vision blurred, asthenia.  Additional Information: No known allergies. No other Vaccine in four weeks. No other medications in two weeks. If covid prior vaccination and If covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination: nasal swab. covid test name post date: 19Jan2022; Covid test result: Negative.  No follow-up attempts are possible. No further information is expected.
mild stroke; loss of taste and smell; loss of taste and smell; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN8732) via an unspecified route of administration on 23Mar2021 at 08:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, and a-fib (atrial fibrillation), all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications ("other medications in two weeks") included carvedilol, hydrochlorothiazide and losartan, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 24Mar2021 the patient experienced loss of taste and smell, fatigue and headache and on 26Mar2021 the patient experienced mild stroke. All events resulted in an emergency room visit and resulted in hospitalization from 26Mar2021 to 29Mar2021. The clinical course was reported as follows: "Second dose on 23Mar2021, loss of taste and smell, fatigue, headache on 24Mar2021 and 25Mar2021. Went to (Hospital name) on Friday 26Mar2021 and diagnosed with a mild stroke. Stayed in hospital until Monday 29Mar2021. Prescribed a blood thinner (Eliqus) per already engaged cardiologist. As of 13Apr2021 still no taste or smell; gaining energy." Therapeutic measures were taken in response to the adverse events and included treatment with "medications to lower blood pressure and a blood thinner". The patient underwent a nasal swab COVID-19 test post vaccination on 26Mar2021 which was negative. The clinical outcomes of the events loss of taste and smell were not recovered; mild stroke, fatigue and headache were recovered/resolved on unspecified dates.
COVID-19 positive : Nausea, vomiting, diarrhea, congestion, cough, loss of taste and smell, headache, exhaustion
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroisism" (unspecified if ongoing); "Known allergies: Mango" (unspecified if ongoing), notes: Known allergies: Mango. Concomitant medication(s) included: VENLAFAXINE, start date: 01Sep2021, stop date: 06Aug2022; LEVOTHYROXINE, start date: 01Nov2020, stop date: 21Aug2022; THYRONINE, start date: 01Nov2020, stop date: 21Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with Paxlovid from 06Aug2022 to 09Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mother reports "swelling, warmth and tenderness in left upper arm" 2 days after receiving shots and then a red rash developed at injection site and spread all over his body. Rash on 8-18-03.
rash on her arm./2 spots/it went down to her arm and elbow; Experiencing pain down her shoulder to her hand/excruciating pain/pain in her arm; shingles on her arm; hardly sleep at night; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 29Mar2021 (at the age of 81 years old) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first vaccination of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on Mar2021 for COVID-19 immunization and had no reaction. It was reported that on 29Mar2021, she received the second dose and 10 days later (08Apr2021), she started experiencing pain down her shoulder to her hand. She described it as "excruciating pain". It lasted for almost 7 days and is still ongoing. She could hardly sleep at night due to the pain in her arm. It looks like she may have shingles on her arm, as per her doctor. She added that she now has a rash on her arm. Yesterday, she had 2 spots and today it went down to her arm and elbow. Her doctor prescribed her antivirals. The outcome of the events shingles on her arm, hardly sleep at night and rash on her arm./2 spots/it went down to her arm and elbow was unknown; outcome of Experiencing pain down her shoulder to her hand/excruciating pain/pain in her arm was not recovered. She also added that her daughter received the  vaccine and also has pain in her arm now.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Colostomy/I lost part of my sigmoid colon, due to perforations; Skeletal symptoms; loss of a percentage of balance; joint & spine pain; joint & spine pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 VACCINE (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LARGE INTESTINE PERFORATION (medically significant), outcome "unknown", described as "Colostomy/I lost part of my sigmoid colon, due to perforations"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "Skeletal symptoms"; BALANCE DISORDER (non-serious), outcome "unknown", described as "loss of a percentage of balance"; SPINAL PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "joint & spine pain". The patient specified that 3 days after a positive Covid test, he/she lost part of sigmoid colon due to perforations that ended up with a colostomy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300149460 same patient/drug, different dose/event;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single, on 23Mar2021 as dose 2, single, on 29Nov2021 as dose 3 (booster), single and on 20May2022 as dose 4 (booster), single at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "NAFLD" (unspecified if ongoing); "Mild Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 23Jun2023 to 27Jun2023 for COVID-19 treatment.
Patient became dizzy after receiving Tdap, MCV4. Did not pass out. Placed supine, monitored for 15-20 minutes. Fully recovered.
APPROXIMATELY 3 HOURS AFTER RECEIVING HER FLU VACCINE, PATIENT STARTED TO COMPLAIN OF THE FOLLOWING SYPTOMS: EYE REDNESS WITH SWELLING AND ITCHING, THROAT SCRATCHY, HAD URGE TO CONSTANTLY CLEAR THROAT AND BEGIN TO FEEL LIKE IT WAS SWELLING.  SHE NOTIFIED NURSING SUPERVISOR AND BEGAN TO FEEL LIKE HER THROAT WAS CLOSING AND WAS SENT TO THE ER.
Constipation; problem with urination; problem with back and front; feels miserable; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), DYSURIA (problem with urination), BACK PAIN (problem with back and front) and FEELING ABNORMAL (feels miserable) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M26A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EMPAGLIFLOZIN (JARDIANCE), ALFUZOSIN, ABIRATERONE, WARFARIN SODIUM (COUMADIN), DILTIAZEM, METFORMIN and ROSUVASTATIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation), DYSURIA (problem with urination), BACK PAIN (problem with back and front) and FEELING ABNORMAL (feels miserable). At the time of the report, CONSTIPATION (Constipation), DYSURIA (problem with urination), BACK PAIN (problem with back and front) and FEELING ABNORMAL (feels miserable) outcome was unknown.            Treatment information included Liquid Dulcolax and Miralax.
Syncope. LOC less than 1 minute. Treatment: patient placed in supine position, knees elevated.
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 49-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 07-Jan-2021 at 11:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 11:02 AM, 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 49.66.  Concomitant products were not provided.  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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Ptosis -right eye. Has seen optometrist and ophthalmologist. Referred to neurologist.
This case was reported by a healthcare professional and described the occurrence of low Hepatitis B antibody level in an adult male subject who was vaccinated with Hepatitis B. In 2001 the subject completed the Hepatitis B vaccine series. Seven years after vaccination with Hepatitis B vaccine, the subject was tested and showed a Hepatitis B series again. His titer was taken and shown to be 12500 following completion of the second series of Hepatitis B vaccine. At the time of reporting the event was considered to be resolved.
approx 8hr p/vax pt noticed swelling & soreness of lt upper arm;by next day swelling & soreness had moved down arm to elbow & now included redness;heat was applied w/some relief;redness & swelling (mild 4-5" from elbow;
Hives all over chest, back , upper arms, upper legs Fever Body aches Hurt to breathe  Headache  Sick to stomach  Fatigue
Began having shortness of breath 12/3/2021. Came to the hospital 12/9/2021 with increasing shortness of breath and hypoxia. Chest xray consistent with multilobular pneumonia. Required intubation and mechanical ventilation. Continued to deteriorate and  expired 12/27/2021.
Dizzy Bad taste in mouth  Chest pressure  Went to ER and was monitored and tested to make sure heart was fine and all came out fine.
Chest pain, fatigue, lightheadedness, malaise, rapid heart rate started 3 days after vaccine and continues 6 weeks later.