chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles, received both doses/ Suspected vaccination failure; shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case was reported by medical assistant. The patient received 2 doses of Shingrix about 4 years ago from reporting. At the time of reporting the patient had active Shingles outbreak. The reporter was not sure why or how this happened but would like more information on that. The reporter consented to follow up. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100478:Same reporter
After receiving the Pfizer vaccination I experienced a hot spell over my body. I experienced nausea, sweating headache and it all happened at the same time. I also experienced body aches and then after 15mins  I became very fatigue.  Over the course of the next week I  noticed a cyst on my back that grew really fast and as it grew I applied warm compresses. It became the size of a golf ball I then visited the ER and the cyst was drained.
Sick after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after first vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ILLNESS (Sick after first vaccine). On 16-Jan-2021, ILLNESS (Sick after first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-292111 (Patient Link).
she totally got her insides ripped up/ she got the Pfizer Covid shot and now has heart problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "she totally got her insides ripped up/ she got the Pfizer Covid shot and now has heart problems". Therapeutic measures were taken as a result of cardiac disorder.  Additional information:Caller stated that patient got the Pfizer Covid shot and now has heart problems. You couldn't pay her a million dollars to take it again. She now has to be on Eliquis for the rest of her life. Her son is worried something is going to happen to him too. More and more people are getting heart problems and you really don't know how people are going to be afterward. All Pfizer cares about is making money, whether that's off shots or making money off Estring and not letting anyone know when the patent ends. She wanted to let Pfizer know that senior citizens cannot afford Estring because health insurance won't cover it and its much cheaper to go to (country withheld) to purchase.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300156709 same patient and different drug/events.;US-PFIZER INC-202300156131 same patient and different drug/events.;
Almost immediate right sided throat swelling, followed by throat tightness, chest tightness with wheezing/coughing and abdominal cramping - all reported to physicians office as having been a previous reaction to the flu vaccine. Treated at home with oral Benadryl and steroid.
Extreme fatigue for 3 days  Itching all over body  Soreness in right arm where the vaccine was received  Treatment: cortisone cream and tylenol 2 days after vaccine  Outcome: Improved and better on 4th day
Vaccine arm, COVID arm  Huge bump  Red and warm around injection site Pain and swelling  Followed by low grade fever and slight headaches
rash all over like measles; Skin was red like she had measles; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MORBILLIFORM (rash all over like measles), ERYTHEMA (Skin was red like she had measles) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol since 2010. Concomitant products included ATORVASTATIN for Cholesterol.   On 17-Feb-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced RASH MORBILLIFORM (rash all over like measles), ERYTHEMA (Skin was red like she had measles) and FATIGUE (Tired). On 22-Mar-2021, RASH MORBILLIFORM (rash all over like measles) and ERYTHEMA (Skin was red like she had measles) had resolved. At the time of the report, FATIGUE (Tired) had resolved.            No treatment medication was taken.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: NNI On 08-Apr-2021: Vaccination time added, event outcome updated (resolved),  medical history and indication for concomitant medication updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Reddened, swollen deltoid/upper arm with redness and swelling into upper chest
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered improperly stored GARDASIL 9 for prophylaxis lot #1586751 and expiration date 16-FEB-2021 (strength, dose, frequency and route of administration were not reported).  No adverse effects were reported. The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-09507513-1901USA010543: US-09507513-1901USA010542: US-09507513-1901USA010541: US-09507513-1901USA010539: US-09507513-1901USA010540.
The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost passed out; tired; nausea; headache; almost passed out; Hypertension/BP 155/103; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, expiry date not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at a single dose for COVID-19 immunisation. Medical history included interstitial cystitis and endometriosis, known allergies to milk and sulfa, have had a complete hysterectomy, and patient was getting hormone injections. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior to vaccination. Concomitant medications were unspecified; it was reported that patient had other medications in two weeks. The patient previously took ibuprofen and experienced known allergies; and had first dose of bnt162b2 for covid-19 immunisation on an unknown date.  The patient had no other vaccine in four weeks. The second day after injection (06Mar2021), temperature dropped to 93.7, BP 155/103, and patient was very cold. Patient was dizzy, almost passed out (Mar2021). Patient temp ran from 97 to 98 and was able to get temp up to 95 (2021) but it's been there and dropping to 94.9 since 06Mar2021. Patient did have hypertension BP but take meds for it (Mar2021). Patient was also very tired, nausea and headache on and off (Mar2021). But all those have been reported. It's not normal for the patient to be cold because patient have had a complete hysterectomy and was getting hormone injections. Therapeutic measures were taken as a result of the event hypertension. No treatment received for the other events reported.  The patient was not tested for covid post vaccination. The outcome of the events was not recovered.
This spontaneous report as received from registered nurse refers to a unspecified number of patients of unknown age and gender. Patient medical history and other previous drug allergic reactions were not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (dose number, lot number and expiry date unknown) for vaccination. No concomitant therapies were reported. Since 07-NOV-2014 (Oka/Merck) VARIVAX have been exposed to additional temperature excursions and additional unspecified number of improperly stored doses of (Oka/Merck) VARIVAX have been administered to patients. Action taken with (Oka/Merck) VARIVAX was unknown. The outcome of temperatures outside of the proper storage range, exposed to additional temperature excursions and no adverse effect was unknown. The reporter considered temperatures outside of the proper storage range and no adverse effect to be not related to (Oka/Merck) VARIVAX. This case # 1411USA009134 is linked to case # 1411USA007174 via same reporter link. Additional information has been requested.
Arm was sore for a few days after the vaccine, with a little bruising/hardness in the area, and then went away. Then 6 days after the vaccination, the hardness expanded and the area has a red bruise. It is about 3 inches in diameter and itches sometimes, but isn't sore. I put heat on it and tried to massage it, like I would a normal bruise that I want to expedite healing of. The area is also swollen/raised a bit. It has now been three days of that. The hard area is reducing a tiny bit each day, but not much.
Raised rash around collarbone neck and back [...] red and itchy; Raised rash around collarbone neck and back [...] red and itchy; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm, on 24Feb2021 (Batch/Lot Number: EL3247SCH), at the age of 75 years old, as 1st single dose, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included hydrochlorothiazide, omeprazole, pregabalin (LYRICA), meloxicam, propranolol, loratadine, fluticasone propionate (FLONASE ALLERGY RELIEF), vitamin D, docusate, paracetamol (TYLENOL), and leflunomide. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced raised rash around collarbone neck and back occurring approximately 1 week post vaccination. It was not fluid filled, but red and itchy.  She saw her primary care provider (PCP) about 1 week post symptoms (about 2 weeks post vaccination) and was given triamcinolone 0.25% cream as treatment and was told to follow-up with a dermatologist and immunologist. Itching relieved temporarily with cream but the rash was still there at the time of the reporting. Dermatology appointment was scheduled for 19Mar2021. She was scheduled to receive second vaccination dose on the day of this initial reporting. The patient was considered not recovered from the event. Since the vaccination, has the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
10 cm erythemic raised rash with pain of "8" on a 0 - 10 scale. Suspect vaccine reaction and possible infection.
Onset of Raynaud?s syndrome with 3-5 days. Severe joint pain beginning in hands and later moving through the body. Fatigue. Nausea. Headaches. Diagnosis of Sjögren?s syndrome. On April 8th following nerve tests and several blood tests.
Vasovagal, blood pressure increase, heart rate increased to 187, dizzy, light head.
1 cm area of erythema @ vaccine site right arm 24 hours after injection, 3 X 3 cm area of erythema with petchime in burn-like distrubution @ vaccine site right arm 48 hours after injection, no fever, pain, irritability
Moderate pain lasting > 4 days. Slight redness, some swelling at site. Mild fever - gen. malaise 1st 48 hours. Stiffness in upper (L) arm.
Dizziness, fast heartbeat, chills, nausea and vomitting, diarrhea, joint pain, fatigue.  Hand on left arm where injection was given had swollen fingers.
Pediatric vaccine diluted with 0.13mL instead of 1.3mL so the patient got a more concentrated dosage than recommended. Patient presented pain at injection site the first 24 hours.
Events are all typical symptoms expected for the smallpox vaccine.  Day #9 of vaccination.  Extreme fatigue, fevers, chills, and bodyaches.  Wound appears normal with wide induration and central lesion (sligtly less than dime size)  Extreme tenderness at left axilla.      I submit this report in accordance with DoD request for quarters.  I placed her on quarters for tomorrow - will miss day of work and thus I submit this report.
Pt c/o of feeling flushed and warmth at the injection site a few seconds after the administration. Pt experienced difficulty breathing, shortness of breath, and "lump in the throat" 0.3 ml of Epinephrine was administered SQ via Epi-Pen. Pt continues to experience the "lump in the throat" for additional 10 minutes. Physician was at the site, 3mg of Zofran was given orally for nausea.
Fever 100, body aches, vomited in am reported by patient. Fluids and Tylenol. 3/19/2014 reported feeling better.
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient passed out 3 minutes after receiving vaccine, came to after about 1 minute. EMS called and evaluated patient, patient refused to go to hospital.
Invalid Dose "Administered"; This spontaneous case was reported by a pharmacist and describes the occurrence of incorrect dose administered (Invalid Dose "Administered") in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication.     The patient's medical history was not provided. Concomitant product use was not provided.    On 16-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscularly). On 16-Mar-2021, the patient experienced incorrect dose administered (Invalid Dose "Administered"). At the time of the report, incorrect dose administered (Invalid Dose "Administered")   Seeks permission to administer another dose the same day. For mRNA-1273 (Moderna COVID-19 Vaccine) (injection), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.
joint pain in her knees and hips; tired; arm hurt from the injection site to her wrist.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurt from the injection site to her wrist.), FATIGUE (tired) and ARTHRALGIA (joint pain in her knees and hips) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm hurt from the injection site to her wrist.). On 05-Mar-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced ARTHRALGIA (joint pain in her knees and hips). On 04-Mar-2021, VACCINATION SITE PAIN (arm hurt from the injection site to her wrist.) had resolved. On 05-Mar-2021, FATIGUE (tired) had resolved. At the time of the report, ARTHRALGIA (joint pain in her knees and hips) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication information was provided. No treatment products information was provided.
Expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.   On 05-MAR-2023, the patient received Havrix 720. On 05-MAR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-MAR-2023  The pharmacist called on behalf of another pharmacy location where a patient was administered a dose of Havrix, which was expired. The pharmacist stated that the incident had been reported.   At the time of reporting, the vaccine had not been repeated. The reporter gave permission to follow-up with either him or the pharmacist listed under vaccine facility. The reporter consented to follow up. The patient was administered a dose of expired Havrix, which led to expired vaccine used.
I started feeling anxious/ little afraid; heart was a little bit fast; heart feels even faster; not that much sleep; 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), administration date 26May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunization. The following information was reported: ANXIETY (non-serious) with onset 26May2021, outcome "unknown", described as "I started feeling anxious/ little afraid"; HEART RATE INCREASED (non-serious) with onset 26May2021, outcome "unknown", described as "heart was a little bit fast; heart feels even faster"; INSOMNIA (non-serious) with onset 26May2021, outcome "unknown", described as "not that much sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got second shot just a bit ago may be like 5 or 6 hours ago and about in hour or two ago started feeling anxious and heart was a little bit fast and then not that much sleep. The patient slept very much last night (Further not clarified hence not captured in tab) and then the patient fall asleep on couch for may be for 30 minutes and woken up and heart feels even faster so the patient just little afraid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After second covid shot about a week later sensation of ulcer in nasal passages that moves around day to day.  Irritating, almost feels like a zit expanding inside the nose but then next day in a different area of nose   Continues still
Extreme Body Aches , headache 99.5 fever 6am 5/14;Fever increase to 102 F. By 8am to 6pm then down to 99 F and back to normal by 5/15. Woke up with body rash from neck down to 1/2 torso and center of forehead from 5/15 to  5/16.
Ever since I received the flu shot my shoulder muscle has experienced pain right where the needle entered. Also, most troubling, my elbow has been damaged. My elbow has been in chronic pain and stiff and movement is limited. I have lost most of the strength in my left arm.
Client fainted after receiving her vaccinations. She fell to the floor from a seated position. Client came to immediately after fainting and falling. Client was given ice packs to cool her off, peanut butter crackers, and water. Vitals were monitored. No injuries noted. Client left with mother after being observed in clinic for further reactions. Client states that she felt better and appeared to have completely recovered at the time of leaving clinic. I will contact client's mother this afternoon to check on her.
Information has been received from a case in litigation concerning a female minor child who was vaccinated with vaccinations containing the mercury-based preservative thimerosal. It was alleged that through vaccinations administered during the first three years of life, the patient was subjected to very high doses of the mercury contained in thimerosal, "a highly toxic preservative." The patient was allegedly poisoned by the cumulative doses of mercury in thimerosal. It was alleged that as a result of the mercury in the thimerosal-containing injections, the patient now suffers, and in the future will suffer, from the toxic neurological effects of mercury poisoning. Upon internal review toxic neurological effects and mercury poisoning were considered to be other important medical events. Follow-up information has been reported in a published article that the patient on an unspecified date was vaccinated with MMR II or a thimerosal containing vaccine (manufacturer unknown). It was reported that the vaccine cause autism. The patient's mother noticed a decline in the patient's development in late May 1999 or shortly thereafter. Upon internal review, autism was determined to be an other important medical event. No further information was available.