chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching on chest; Rash; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on chest), RASH (Rash) and MYALGIA (Body aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M70) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itching on chest), RASH (Rash) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Half. At the time of the report, PRURITUS (Itching on chest), RASH (Rash) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-083047 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received contains No New Information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083047:2st dose Case
15x5cm erythematous, warm rash w/darker margins & little control clearing in upper lt anterior lateral arm almost hive like;positive itching as of 24MAR98 (examined by MD);
SWEATING ON FINGERPRINTS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series: 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sweating on fingerprints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sweating on fingerprints was not reported. This report was non-serious.
Her upper arm ache for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her upper arm ache for a day and a half) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TRAMADOL and SUMATRIPTAN for Migraine, POTASSIUM, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM and MOMETASONA [MOMETASONE] for an unknown indication.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced VACCINATION SITE PAIN (Her upper arm ache for a day and a half). On 23-Dec-2020, VACCINATION SITE PAIN (Her upper arm ache for a day and a half) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
L deltoid-hot and red with burning at top of shoulder. Keflex 250/5-1 1/2 tsp BID x 10 days.
Shortly after the shot. Experienced heaviness/pressure/tightness to left side of head and has been experiencing symptoms since for 13+ days: over the counter Tylenol/Motrin Sudafed with no relief. Also had video chat, urgent care visit and return visit with primary care physician: have labs and CT ordered and pending
Adverse event: chills, sweats, severe joint pain, severe body aches,  and fatigue Treatment: rest and hydration
First time Grand Mal seizure, severe concussion, confusion. lasting 5 min. Transported by ambulance to hospital. Admitted to telemetry overnight.
I have numbness or tingling (pins and needles) in fingers, arms, feet, legs, back, knees
Pain, redness, raised semi solid knot X 1 week. Area 10mm rechecked  7/30/09. Much improved LE pain
pt recv vax & devel red & swollen arm; pt felt there was a problem w/lot of vax;
Pfizer 9/24/21, 10/26/21. Positive on 12/12/22
Passed away; Vccine didn´t do one bit of good continued to have outbreaks/suspected vaccination failure; shingles outbreaks; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles several times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Passed away) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Vccine didn´t do one bit of good continued to have outbreaks/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles outbreaks). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the unknown cause of death, vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient's children via interactive digital media. The reporter stated that when the shingles vaccine came out he/she made sure patient got it.  The reporter further stated that shingles vaccine did not do one bit of good.  She continued to have outbreaks of shingles until she passed away. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Reported Cause(s) of Death: Unknown cause of death
At first, tired, but by midnight I had chills, aches, and fatigue. In general, flu-like symptoms for 24 hours.
Started feeling ill on 2/28/01 with sore throat and complained of painful and difficulty swallowing. Complained of swelling of throat to ear.
Dizzy, chills, no fever, exhaustion on day 1 (took 2 Tylenol) Tiredness next day
I woke up with chills the night after the shot. I had heat and swelling where the shot was injected. I felt sick fatigue, vomitting, diarrhea for about a week.  I also ran a fever.
R arm rash onset 10 days after vaccination in the same location.  4cm x 7cm lightly erythematous irregular oval with a rim of 0.5-1cm darker erythema around the border.
Stroke -- symptoms of stroke came on suddenly spent a month in hospital / rehab still going through physical therapy
Patient's mother stated that her daughter started experiencing an itchy sensation on the scalp starting about one week after vaccination that has continued through today (8/13/21). Upon physical examination, hair looked dandruff free and there was no visible dermatitis/irritation at the hair line or along part. Mother stated they tried benadryl in case it was an allergy but that did not help. Mom checked for lice nits and did not see any either. Lastly, they tried OTC Dandruff shampoo and that also did not work.
Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.
18 mo with fever to 103 24 hours after vaccines-dx'd with croup pneumonia.
NAUSEA, UP ALL NIGHT VOMITING, SHAKES, JOINTS HURT, CONGESTED LUNGS, CHILLS AND SWEATING
Narrative:  65yo male patient in treatment at medical center for lung cancer with mets died on 11/6/2021. Pt had received 3 covid vaccines on 1/8/21, 2/5/21 & 9/7/21. Death is not related to covid vaccines.
I was exposed alot during the past week to a person that has tested POS. for Covid19. And i now have a sore throat.; I was exposed alot during the past week to a person that has tested POS. for Covid19. And i now have a sore throat.; I was exposed alot during the past week to a person that has tested POS. for Covid19. And i now have a sore throat.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (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; Covid-19 vaccine (DOSE NUMBER UNKNOW (BOOSTER), SINGLE, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), OROPHARYNGEAL PAIN (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "I was exposed alot during the past week to a person that has tested POS. for Covid19. And i now have a sore throat.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was exposed alot during the past week to a person that has tested POS. for Covid19. Therapeutic measures were not taken as a result of drug ineffective, covid-19. It was reported that patient had not received any Other Medication in 2weeks. Patient had no known allergies. It was reported that patient was exposed a lot during the past week to a person that has tested POS. for Covid19. And now had a sore throat The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3/4/2009 at 7:30pm child had a seizure lasting about 1.5 minutes. No fever. Complained of feeling tired before and after taken ER treated and has a follow-up appointment.
2330, 16 Sep 09.  Pt states the left side of her face was numb, drooping, and drooling.  It resolve spontaneously by 0530 on 17 Sep 09.
Made wife ill, muscle aches, pain. 2nd shot was worse. Then wife developed a rash which did not go away and now 1.5 years later wife has uncontrolled atopic dermatitis which will cost 50k/yr in medication or more, which I cannot afford and which my healthcare plan refuses to cover.   It cannot be proved by the dermatologist that the Shingrix vaccine caused the disease, but the disease is ideopathic. Previous to this vaccination, my wife had no allergies or chronic conditions or illness related to immune system.
Sore arm at the injection site which was very painful for 2 days.  patient also complained of runny nose on 3/4 which lasted for about 4 hours.
Patient states within hours of receiving injection had sharp pain in left arm and cannot life arm up need to use. Has to use other hand to help lift arm still has sharp pain that effects her sleep. Has been seen by primary care physician how has diagnosed her with left axillary arm nerve damage, was given 2 prescriptions on 11/5 1 for pain 1 for a steroid. Patient has been to physical therapy and still has difficulty and pain with arm is being referred to a neurologist for further care.
Onset of severe pain in Rt deltoid shortly after receiving immunization, noted malaise the next day and  and development of a macular, red, confluent rash at injection site, over lower abdomen and mid back approx 2 days later. RASH STILL PRESENT AS OF THIS REPORT.
COVID 19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid 19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 infection was not reported. This report was non-serious. Product complaint number: 90000176141; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
one week after injection have red rash and itching for past 5 days with no lessening of symptoms
Fever 103 degrees - 104 degrees, shaking pain on (R) leg. Very fussy. Started on 5/24/12 around at 7:00 pm.
Employee received Pfizer COVID-19 vaccine on 12/23/2020.  Waited 15 minutes after immunization and felt fine.  Started to have a hot flash on the way home.  Then her tongue felt sluggish but not swollen.  She had a few minutes having difficulty swallowing but denies a sensation of throat swelling.  Arm became sore and heavy but no redness.  Drove back to the hospital with the onset of these symptoms and waited in the parking lot for 15 minutes to see if the symptoms were going to progress but they didn't.  Stated she became very fatigues for a few hours but felt fine the next day except for a sore arm.
COVID-19 positive PCR on 4/8/21, symptomatic  Narrative:
Had the shot and had a reaction/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot and had a reaction/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via  interactive digital media. The patient had the shingles shot and had a reaction (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Past medical history of hypertension, diabetes mellitus, cardiomyopathy, ESRD on HD who presented to ER with shortness of breath with oxygen saturations in mid 80s. CT angiogram chest negative for PE, noted to have bilateral pneumonia. She tested positive for COVID-19 virus. Patient was seen by ID and was treated with antibiotics, remdesivir, steroids, and Lovenox. Inflammatory markers started to improve along with her oxygenation. She was down to 2 L oxygen. Patient was seen by Nephrology and dialysis was continued. Patient was discharged home after cleared by consultants. Disposition: Home with home health.
These symptoms lasted about 48 hours.    Chills, low-grade fever, body aches, severe headache, nausea (didn't throw up) and fatigue
This spontaneous report was received from a 61 year old female patient who was reporting on herself. The patient had no pertinent medical history and no drug reactions or allergies. Her concomitant medications included atenolol (+) chlorthalidone. On 24-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and site of administration, lot number and expiry date were not reported) for shingles prevention. On approximately 28-MAY-2017, reported as 4 to 7 days after receiving ZOSTAVAX, the patient experienced a rash on her arm. The patient sought medical attention. No treatment was given for the event. Laboratory diagnostic studies were performed, but the results were not provided. No product quality complaint was reported. The outcome of rash on the arm was unknown at the time of reporting. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as there was no permission to contact the reporter.
Eye puffiness; Minor Headache; Swollen eyelids; This is a spontaneous report from a contactable consumer. This 62-years-old female consumer (patient) reported for herself. A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0217), dose 1 intramuscular, administered in Arm Left on 16Jun2021 04:00 (at the age of 62-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism, drug hypersensitivity. Concomitant medication(s) in two weeks included levothyroxine sodium (SYNTHROID) taken for hypothyroidism; ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). The patient had allergies with tetracycline and avolox antibiotics. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. At day 5 post covid vaccine, the patient experienced minor headache, swollen eyelids on 21Jun2021 06:00 and had eye puffiness on 26Jun2021. No discharge or stuffy nose. The patient received treatment for event eye puffiness. The seriousness of the event was considered as non-serious. Outcome of the event was not recovered and eye puffiness was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
5 patients received an expired vaccine dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received an expired vaccine dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received an expired vaccine dose). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 patients received an expired vaccine dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. The vial was placed in refrigerator from freezer on 9 Sep 2021 and health care profession stated that the patients will revaccinate on 29 10 2021.
Very strong flu like symptoms including fever, body aches, head ache, and slight nausea.
28 week and 2 days gestation at time of Tdap administration. Patient reports "extreme fatigue" and inability to stay awake over the course of > 24 hours. She also reports headaches, arm pain and body pain along with swollen at injection site. Denies redness or pain at injection site.
This case was reported by a nurse via sales rep and described the occurrence of injection site burning in a 39-year-old female patient who received BOOSTRIX. On 31st October 2017, the patient received BOOSTRIX (subcutaneous) .5 ml. On 31st October 2017, immediately after receiving BOOSTRIX, the patient experienced injection site burning and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site burning was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site burning to be related to BOOSTRIX. Additional details were reported as follows: The patient received BOOSTRIX at her personal OBGYN physician office. The patient was a healthcare provider and felt that, the vaccine was administered subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. Immediately after receiving the vaccine, the patient had burning and stinging at the injection site. On 3rd November 2017, 3 days later, the patient still had pain at the injection site which was noticeable enough to be out of the ordinary. The patient did not seek medical attention. The patient thought that, the administration of BOOSTRIX caused her pain at the injection site. The reporter gave consent to be followed up.