chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This child had fever, swelling and redness upper right arm. Taken to the doctor's office later that day vaccines were given. Started on antibiotics. The next day his fever was up to 102, rash all over face and body, right arm was swollen, red, much discomfort. Taken back to the doctor. Today (09/28) right arm still red and swollen, still has faint rash both arms. Advised warm soaks.
On evening of 04/13/2021, Right leg muscles severely cramped. Could not bare any weight. Numbness in right foot. Used walker to help move.  No weight on right leg for 10 hrs could not walk. Pain Started easing , used walker to get up and down the morning of the 14th.  Using walker to assist in moving.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa and penicillin family drugs" (unspecified if ongoing), notes: Known allergies: Sulfa and penicillin family drugs; "Known allergies: Sulfa and penicillin family drugs" (unspecified if ongoing), notes: Known allergies: Sulfa and penicillin family drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid from 20Nov2022 to 25Nov2022.    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.
This spontaneous report was received from nurse referring to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. Since 26-DEC-2016, the patients had been vaccinated with improperly stored doses (incorrect product storage) of VARIVAX (lot # M006157 with an expiration date in 05-FEB-2018), for prophylaxis (dose, dose number, route and frequency were not provided). The doses underwent a temperature excursion > -15 degrees Celsius but < -10 degrees Celsius with a time frame of 2 hours and 19 minutes. The digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA008630: US-009507513-1702USA001653:
Information was received on 14-JUL-2017 from a physician who reported that an unspecified 20 year old patient (gender unknown) received a dose of ZOSTAVAX (date, dose, lot#/expiration not reported) with diluent (lot#/expiration not reported) instead of VARIVAX. The physician reported that the patient had no history of varicella vaccination. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Moderna COVID?19 Vaccine EUA Significant Pain and Swelling at injection site starting approx 6 hours after injection. I took 200mg Aleve tablet at 12 hours after injection
Unable to bear weight in right leg evening after vaccines given on 10/31/2000. Slowly improved & back to normal by 11/2/00. No residual defects.
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 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm 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: "Known allergies: Sulfa" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE], start date: Feb2021, stop date: 10Oct2023. Past drug history included: Keflix, reaction(s): "Known allergies: Keflix". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negetive, notes: rebound Covid - test positive again after testing negative 3 days ago; Positive, notes: rebound Covid - test positive again after testing negative 3 days ago. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Raised pink swelling with hard "knot" underneath 1/2 inch away from injection site with some discomfort reported. Painful at 6:30AM 10/29/15 upon awakening.  Administered ibuprofen chewable 200mg along with food at 6:45AM. Local pain, swelling and hard area under swelling continued and lymph nodes in groin were swollen and hard at 3:00PM. Administered 200mg ibuprofen with food at 4:30PM. Situation continued at 6:30AM 10/30/15. Swollen, pink, warm area measured 2 1/2 inches across and 1 1/2 inches down at 6:45AM. Administered 200mg ibuprofen with food at 6:50AM. Reported reaction to Dr's office at 8:30AM and received appointment for 2:45PM. Child examined by doctor, who called it a local reaction to the vaccination. Ibuprofen 200mg administered with food for local pain at 4:30PM. Increased pain in groin lymph nodes 10/31/15 at 7:30AM. Administered 200mg ibuprofen with food at 7:45AM.
Pt states 72 hours after getting his vaccine, he had lowered mobility in both legs.  It is still occurring now.
Severe headache,   joint pains, nausea, sweating, fever, shivers, difficulty breathing, chest feels compressed, my feet ( in which I have neuropathy ) went numb. Started the evening of the injection, and is now - 3 days later still as intense
Had shaking chills and felt chilled for several hours; didn't check her temperature. Also noted body aches. Denied any other symptoms.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was reported.
The lady who administered the shot, gave it to me in my shoulder, causing nerve damage. Ever since then, all along my arms and upper chest, I have a felt different sensations. This made me think I have myocarditis/heart problems. In reality, it has caused me anxiety and distress for nearly 2 weeks!
Information has been received through a pregnancy registry from a physician and a 28 year old white female with no known allergies or pertinent medical history and a history of one full-term birth and no history of birth defects, stillbirth, or miscarriage who on 25-JUL-2006 and 22-AUG-2006 was vaccinated with a first and second dose of VARIVAXx (lot# 653360/0361F) respectively. Concomitant therapy included ZYRTEC and FLOVENT. It was noted that the patient was not tested for varicella antibodies before vaccination. Subsequently, "right after the second dose," the patient discovered that she was pregnant. The date of her last menstrual period was 14-JUL-2006 and her estimated date of delivery is 22-MAY-2007. It was reported that an ultrasound was performed, results were not provided. On an unspecified date in approximately July 2006 the patient developed a local reaction at the vaccination site. No further information was available. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2007;5/16/2008. Follwup information was received froma aregistered nurse indicted that the patient had a normal pregnancy and delivery. The patient and the baby were both doing well. No further information is available.
Local discomfort at injection site, diarrhea, chills, dizziness, fever, headache, myalgia, muscle stiffness, tachycardia, fatigue
After the vaccine was received and couple of minutes after as I was talking to a few people that was with me, I started to have this metallic taste in my mouth. Then I started to feel cold all over my body. I was seeing gray and then I felt like I was leaning to my right side. I asked my husband to call the people that was for observation. I felt like I had lost it. I was in the driver seat and the nurses came over to me and asked me to lean my seat all the way back. I felt like I had a heaviness in my chest. Then the nurses kept talking to me. They had to ask me to pull over and the episodes kept happening. Then the doctor came and two people put me on the gurney to monitor me. They checked my vitals and asked questions. The doctor felt like it was just stress. The doctor kept me for about 30 minutes laying down with my feet up. The symptoms would just come and go throughout the day. I went home and it was the same throughout the day. They advised me to call the emergency number if it had gotten any worse. Before I left, they made sure that I could stand on my own and my vitals were all normal.
extreme dizziness and hyper ventilation after 10 minutes of administering moderna booster dose
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 25-APR-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe shingles and post herpetic neuralgia. The patient was prescribed pregabalin (LYRICA) for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
3/30/21 11pm- intense itchiness on legs, left leg had a rash, veins were raised and made skin bumpy, hands red, left wrist swollen.  3/31/21 8:30 am- woke up with itchy face, eyes itchy, nasal congestion.  9:30 am- throat was tightening. Took 2 benadryl. Slept from 10-12:30. When I woke, I had no symptoms.  3:30- itchiness around eyes returned, slight tingling lips.  4:00- contacted healthcare provider. Urgent care was recommended.  6:00- received a steroid. Symptoms went away after about 45 minutes.
On Saturday the 24th, my left inner ear started to ache, Sunday it was hurting more and it felt like I had a bump, Sunday the canal started to close off, Monday the canal swelled & completely closed off and can't hear out of left ear.  I went to Urgent care and the Dr was completely puzzled and said she had never seen an ear that closed off so much she couldn't get the ear tool in.  She tried 6-7 times which was very painful but couldn't see anything but an enormous amount of swelling.  She asked several questions and then said she thinks I am having a reaction to the Pfizer vaccine.  She put me on Amoxicillin,  Steroid Drops, Zyertc, and a Probiotic.  Tuesday called my family practitoner and she put me on a Steroid pill for 5 days. She also told me to contact the CDC.  It is now Thursday and canal is still swollen shut and no hearing.  I have never had an ear infection in my life.
WITHIN A WEEK OF RECEIVING THIS VACCINE, I DEVELOPED TINNITUS. IT HAS BEEN CONSTANT SINCE AT LEAST 10 MARCH 2021 (WITHIN A WEEK OF RECEIVING MY FIRST MODERN SHOT) AND HAS NOT WANED EVEN FOR A SECOND SINCE THEN.
Prior to receiving the shot, client was very anxious about getting the shot, given her prior reaction to a tetanus shot.Within 10 minutes of receiving vaccine, client began to feel weak in the knees, had tightness of chest, a perceived difficulty breathing, a feeling of heat inside her ears, thick tongue, dry mouth.  She was observed and offered cold water and an ice pack.  Within 10 muniutes of this, client requested that she be taekn to ER.  There she was monitored and given benedryl and pepscid.  She was subsequently discharged with a diagnosis of possible mild allergic reaction to vaccine.
The patient was found to have Acute saddle pulmonary embolism with acute cor pulmonale (HCC).The patient was admitted to the hospital medical service for further care.  The patient Underwent a thrombectomy and was put on IV heparin. The patient's initial symptoms have improved dramatically during the hospital stay. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Within 5 minutes of injection into right arm, pt began to have erythema around both injection sites - going up arm to neck, chest & shoulder. C/o puritis. No urticaria - none of a "lacy" appeared. Reaction started to subside within 5-10 minutes. BENEDRYL given & was almost resolved within 20 minutes. No resp. concern, no tachycardia. Pt D/C'ed home
My adverse reaction was a hot flash for about 10min on 12/31/2020 and on 01/01/2021, I found a small pea size lump on my right collar bone area that has now increased in size to a quarter size lump that's mildly tender.
Narrative: COVID infection following COVID vaccine series 01/09, Pfizer, dose #1 01/30, Pfizer, dose #2 08/18 pt cc: no symptoms exposure: unknown 08/19 COVID swab, result: detected 08/29 clinically resolvoed
I received BOTOX on Tuesday 12/28. Thursday evening, 12/30, my hands, arms and scalp began to itch. I took Benadryl and went to sleep. By 4PM the next day, 12/31, my eyes were swollen and I began to break out into full body hives. I went to the ER three times in three days (Friday, Sunday 2xs)  because I was having different allergic reactions every day. For example, 12/31 was swollen eyes, extremely low blood pressure, full body hives, the next day my lips swelled and I was wheezing and later that day the hives were unbearably itchy.
Pt. had a febrile seizure and was evaluated at medical center. Rechecked in our office.
full bladder feeling/ feeling a need to urinate; having excessive urination; something was causing trouble in her bladder & kidneys; something was causing trouble in her bladder & kidneys; injection sites felt hard; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination), RENAL DISORDER (something was causing trouble in her bladder & kidneys), BLADDER DISORDER (something was causing trouble in her bladder & kidneys) and INJECTION SITE INDURATION (injection sites felt hard) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sensitive to sodium) and Immunocompromised.    On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination), RENAL DISORDER (something was causing trouble in her bladder & kidneys), BLADDER DISORDER (something was causing trouble in her bladder & kidneys) and INJECTION SITE INDURATION (injection sites felt hard). At the time of the report, POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination), RENAL DISORDER (something was causing trouble in her bladder & kidneys), BLADDER DISORDER (something was causing trouble in her bladder & kidneys) and INJECTION SITE INDURATION (injection sites felt hard) outcome was unknown.        No concomitant medication was reported. No treatment medication was reported. Reporter was confused because the email mentioned she received a booster and she was told that there was no booster and that she received a third dose of the vaccine on a previous call with a MI agent.   This case was linked to MOD-2021-319270, MOD-2021-319619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received contains additional new events renal disorder and bladder disorder were added.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Horrible itching situation on her arms and legs/pretty bad for so many weeks/every once in a while get bumps that hurt/and then itch), PAIN (Bumps that hurt), ASTHENIA (Debilitating at times) and NERVOUSNESS (Weary and nervous about the booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-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 PRURITUS (Horrible itching situation on her arms and legs/pretty bad for so many weeks/every once in a while get bumps that hurt/and then itch), PAIN (Bumps that hurt), ASTHENIA (Debilitating at times) and NERVOUSNESS (Weary and nervous about the booster). At the time of the report, PRURITUS (Horrible itching situation on her arms and legs/pretty bad for so many weeks/every once in a while get bumps that hurt/and then itch) and PAIN (Bumps that hurt) had not resolved and ASTHENIA (Debilitating at times) and NERVOUSNESS (Weary and nervous about the booster) outcome was unknown.            No Concomitant information was reported. No Treatment information was reported.
chills; felt very tired; was freezing cold and shaking; freezing cold and shaking; severe fever with rigors; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking) and PYREXIA (severe fever with rigors) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking), PYREXIA (severe fever with rigors) and MALAISE (not feeling well). At the time of the report, CHILLS (chills), FATIGUE (felt very tired), FEELING COLD (was freezing cold and shaking), TREMOR (freezing cold and shaking), PYREXIA (severe fever with rigors) and MALAISE (not feeling well) outcome was unknown. Not Provided          Treatment and concomitant medications were not provided by reporter.
This case was reported by a healthcare professional and described the occurrence of vaccine underdose in a 21-year-old female subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline), HAVRIX. There were no concurrent medications. On 10 February 2011 the subject received 1st dose of HAVRIX (unknown). An unspecified amount of time following vaccination with HAVRIX, the subject developed headache and injection site soreness, which resolved on an unknown date. On 11 August 2011 the adult subject received 2nd dose of HAVRIX pediatric in the left arm. The was a vaccine underdose. No additional details were provided. Follow-up received on 16 September 2011 from the healthcare professional: The healthcare professional reported that no adverse events occurred as a result of the vaccine underdose. The healthcare professional considered that the vaccine underdose may have been associated with pediatric Hep A and adult Hep A being together in refrigerator, and Hep A pediatric dose was grabbed inadvertently. The subject returned to the clinic the following day and received the adult dose of Hep A vaccine.