chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ten days following my booster shot, I started itching terribly. It started with my palms of my hands and my scalp but then spread to the rest of my body leaving hives and welts everywhere. After two days of hives all over my body and uncontrollable itching, the welts would appear, stay for up to 20 minutes, then disappear. There were hives and raised, red lines that were eventually diagnosed by three doctors as Dermatographia. The hives and/or lines appear randomly accompanied by itching or burning of the skin. I get them on my face, hands, arms, neck, chest, legs and stomach. I am currently taking 20 mg of Zyrtec in the morning and 10 mg at night.  This helps a lot with the itching but does not keep the hives and dermotographia from appearing.  I also had what felt like an air bubble stuck in my throat a few days following the onset of the hives.  This passed, but the hives have not.
Varicella disease with exposure to three siblings who had varicella vaccine and much later developed shingles and varicella disease.
Patient had warm, stiff feeling in arm and redness/inflammation 4-6" in diameter. Doctor is treating her for skin infection. Treatment for reaction is Doxycycline 100 mg BID and Antihistamine BID.
Severe headache began day 2 and lasted 7 days, extreme dizziness began day 2 lasted 10+ days, stomach aches, no vomiting, tightness in chest, rapid heartbeat, severe swelling at injection site (golf ball size), severe redness at injection site
Headache, body aches the evening of vaccination and for 2 days after. Then on 1/31/21 (Sunday) a big red spot warm to the touch, painful and itchy appeard.
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative; Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sore left arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 019B21A, 032F21A and 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            No concomitant medication were reported.  Patient experienced second episode of sore left arm on 6-APR-2021 and third episode of sore left arm on 12-APR-2022. Patient had no adverse reactions reported with third dose.                No treatment information was provided by the reporter.
In addition to the common side effects of muscular pain, strong headache, chills, instead of nausea, there were vomits, two times. After 4 to 5 hours of the vaccine shot in the left arm, the area was swollen, red and painful.   The adverse event  different than reorted one is that the day after, a bruise appears and still in pain.
Immunized 10-15-09 with Tdap. Hep A, Varicella #1 MENACTRA. To 10-19-09 with varicella rash outbreak to torso, began appearing 10-18-09.
Fatigue and body ache, restlessness, difficulty falling asleep, woke up with headache
No adverse event. Booster dose was given too early. It was given 1 month after the second dose instead of 6 months after the second dose.
Patient sat in observation post injection and after 20 minutes patient reported stabbing chest pain (8/10) for the past 5 mins, patient denies symptoms on last two doses, denies panic attack or allergies to food or medicine. States feels nervous, anxious and has labored breating. Patient is pale, sweaty, clammy and hot to touch (patient was sitting in sun).  VS BP:142/92, T-104.8, P-89, O2 96%. @1227pm.  911 was called and patient moved to shaded and private area. Fire dept. arrived and assessed patient VS and patient had been stablizing and was advised to go to ER due to elevated BP and chest pain.
Pt experienced "ache" in the ankle and toes at 5am the following morning (after receiving vaccine). It continued throughout the day to general body ache. At 3pm she started to get low grade fever (100.1F) and chills. Her arm was painful and bruised.
Pt recvd vax & next day exp fever & body aches resolving in several hr.
Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 42-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included In vitro fertilization on 22-Jun-2020. Concurrent medical conditions included Drug allergy (Allergic to dermerol.), Allergy to nuts (Allergic to brazil nuts.), Fruit allergy (Allergic to mangoes.) and Environmental allergy.    On 08-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 10-Mar-2021. On 08-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred on 03-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 3061 grams (6lbs 12oz). The outcome was reported as Term Birth w/o Complications. On 08-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2020, Pregnancy test: positive (Positive) Positive. In September 2020, Scan: normal (normal) Fetal scan -normal. In October 2020, Echocardiogram: normal (normal) Fetal ECHO -normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. Date of conception reported was 22-Jun-2020. Date of positive pregnancy test reported was 04-Jul-2020.  On 03-Mar-2021, the patient gave birth to live full-term  female baby (length 20) without any perinatal complications. No fetal/infant abnormalities were detected on delivery or at one month post-partum.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up information received included LMP date, pregnancy outcome details and lab data.
From initial information received on June 27 2005 from a health care professional regarding an adverse event, it was reported that a 12 year old male patient received a dose of Menactra vaccine, lot number U1589AA, administered in the right arm at 3:50pm on June 20 2005. Reportedly ten minutes later the patient became pale and felt faint. It was not reported if the patient needed treatment. Reportedly the patient recovered from this event. The reporter of this case is the same reporter of cases: 200501235, 200501236, 200501238, 200501239 and 200501240.
PATIENT GOT DIZZY WITHIN 5 MINUTES OF RECEIVING VACCINE-BECAME UNRESPONSIVE FOR ABOUT 30 SECONDS. SHE CONTINUED TO BE DIZZY/FAINT AND HAD A COLD SWEAT. PT WAS NOT INJURED WITH LOSS OF CONSIOUSNESS. CALLED 911, EMS ARRIVED AND TOOK PATIENT TO THE HOSPITAL. WHILE WAITING FOR EMS BLOOD PRESSURE AND HR CHECKS WERE PERFORMED WHILE PATIENT WAS IN LAYING DOWN POSITION.
Mother called the day after the vaccine was given. She stated the site was enlarged & swollen. C/o dizziness, nausea & blurred vision. To come in to clinic or see pediatrician if symptoms worsen. Mom was advised to try cold compresses & ibuprofen. Taken to PMD. Treated with ibuprofen only.
Left deltoid swelling and erythema developed about 36 hours after vaccine administration, and 12 hours after that it became painful, red, hot, and firm. Presented to care at that time, and Rx for cephalexin given. Abx started today.
pt experienced cold sweat, pale and felt weak, pt stated he had difficulty breathing , paramedics were called. no epipen was injected at the pharmacy. paramedics walked him out the store
This spontaneous report as received from a pharmacist concerning a 44  year old female patient with reflux and arthritis. The pharmacist reported that a patient received an unspecified hepatitis B vaccine "about two years ago" (approximately in October 2011) and a titer was drawn on 19-AUG-2013 which resulted negative. Concomitant therapies included hydrochlorothiazide (manufacturer unknown). On an unspecified date, the patient sought unspecified medical attention. Since the hepatitis B vaccine as unknown to the pharmacist, his was reported as RECOMBIVAX. Additional information has been requested.
Pt. received series of 3 vaccinations - 11/06, 05/07, 01/08.  Pt. noted sl. weight loss - 10 lbs, and enlarged supraclavicular lymph nodes around 2/1/08.  Node grew slightly larger by 3/11/08.  Pt was seen by fam. phys. - cbc done, + cxr.  Cxr abnormal - 4 x 7.4 cm mediastinal mass noted.  CT showed grossly enlarged lymph nodes.  Biopsy performed on lymph node - positive for Hodgkin's lymphoma.  Pt. awaiting appt. with oncology for staging and plan of care.  Component HHV-6 known causative agent of HODGKIN's lymphoma contained in GARDASIL. 5/19/08-records received-Oncology visit 3/25/08-presented with no significant PMH. C/O enlargement of left cervical lymph node at end of 1/08 and upper respiratory symptoms. Four weeks later seen by PCP, C/O pruritus in legs and arms since January as well as patches of dry skin. Chemotherapy.  Follow-up: Since cancer can recur, I have no idea if the event is resolved. Patient continues to received chemotherapy related to HODGKIN's lymphoma. Enlarged lymph node noted i.v. Feb 08 - 1 month after completing the series of 3 vaccinations of GARDASIL. HODGKINS diagnosed 3-14-08
This spontaneous report was received from a nurse, via a company representative, regarding an 82 year old female patient. The patient's medical history included breast cancer and colon malignancies. The subject's concurrent condition included rheumatoid arthritis. Concomitant therapies included methotrexate (manufacturer unknown) and prednisone (manufacturer unknown). In 2009, the patient was vaccinated with ZOSTAVAX injection (dose, lot number and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). According to the reporter, the patient had an active case of shingles at the time of reporting (reported as "now"). The reporter did not provide a causality assessment between the event and the suspect products.
Vaccination was given to patient on 05/12/02022.  Expiry date as per manufacturer was 05/31/2022 but beyond date use was 04/19/2022.  Talked to patient mother and patient is doing great with no side effects, There was no temperature excursion during the storage of vaccine from the time we received vaccine at pharmacy.
No symptoms until 9/15/21 PM -  injection site started to itch, hand, warm to touch, red 9/16/21   no other symptoms other than increased temp    99.5 taken in ear with the above
Very high glucose (>200 mg/dl) starting two days after the flu vaccine that persisted for two days and was dangerous due to the risk of DKA and history of vitreous hemorrhage and DME. Upper respiratory illness.   The manufacturer should provide a warning to diabetics and disclose the efficacy for the current year (a mere 9% for 2019). The amount of mercury in this flu vaccine should be disclosed and the ingredients on the CDC website should be accurate and not omit ingredients (eg, the neurotoxin mercury in any amount). A risk benefit analysis should be done to determine whether their is net benefit for the flu vaccine considering it has the most VAERS complaints of any vaccine.
Kinrix administered instead of Tdap; Kinrix administered to a 25 yo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 25-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 28 DEC 2022 Reporters comment: The nurse reported that Kinrix was administered to patient instead of Tdap. The reporter consented to follow up. Additional supportive information: As 25-year-old patient received Kinrix instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Redness of cheeks, no hives, felt hot and tingling injection sites, fever-had hives the next day
Around 9PM on 16AUG93, pt was very cold & shivering, this subsided p/11PM; next morning 17AUG93 had red raised rash all over body; mom called clinic & took pt to MD 17AUG93;
Facial tingling BP 160/90   HR 85     Resp 18 trelegy  prednisone     ventolin
We administered vaccine. Upon patient's observation period it was noticed that patient began having difficulty breathing and could not speak. We administered an EpiPen (0.3 mg) and I called 911. After the EpiPen patient began breathing better but still required EMS assistance. They escorted her off to hospital. I called patient's primary md and spoke with the nurse who stated they were aware she was in the hospital.
Patient administered adult dose of COVID bivalent booster, and the dosage was 0.3ml and not the recommended dose.
Patient has experienced pain and immobility in the vaccinated arm. Administered on 9/30, has become worse since onset. Patient is concerned damage has occurred.
This spontaneous report as received from a healthcare worker refers to a 10 year old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 08-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
28JAN98 pt recv vax & 30JAN97 pt returned to office w/erythematous sl indurated area noted over lt thigh 7-8cm in diameter noted by MD;
Headache, dizziness and numbness in right hand-Seen if the emergency department.
Information has been received from a Registered Nurse referring to a 4 year old male patient with immunodeficiency. In June 2013 (reported as 2 years ago) the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, rout, lot# and expiration date were unkonwn). Concomitant therapies were unspecified by the reporter. In 2015 (reported as recently) the patient was determined to have low antibody titers. The patient had an office visit for medical attention. No treatment was given for the event. The patient had not recovered from the event. Additional information is not expected as the reporter refused to be contacted.
The pt experienced a fever of 104 within 30 minutes of receiving vaccine. The pt also experienced vomiting that night and diarrhea. On 7/1/00 had a normal physical exam.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Patient suffered a stroke. She was then admitted for rehab on 3/18/21 for 7 days.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M004330, expiration date: 26-JAN-2018, exact dose and route of administration were not reported). Administered dose experienced the temperature excursion of 14 degrees Fahrenheit for 620 minutes and 14 degrees Fahrenheit for 45 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
*8 days after injection i discovered a hard lump (6am)at injection site . by Noon this area was red, sore, swollen and very hot (102). I went to the auditorium where i received the shot at 3pm. the nurses said they have not experienced this 8 days out. A doctor 9dermatologist ) looked at it and drew a circle around the red area and said if the redness spreads to seek medical attention. He asked the nurse not to document this. I went to the ER and the doctor treated me for infection/ cellulitis. After 3 days on antibiotics it has subsided by half.
improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
At first there was a 3 inch by 3 inch red patch that was itchy. Then I woke to my entire bicep being inflamed at the injection site. Almost my entire arm. I went to see the doctor that said it was a strong localized reaction.
tested positive for COVID-19; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (comments: patient has multiple malignancy).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 15-Feb-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment informations was not provided. Patients concomitant medicines include steroids, chemotherapy and immunosuppressants.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked; Sender's Comments: Based on the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.
1st dose of bexsero, 2nd dose trumenba; This non-serious case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a 15-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 07-MAR-2023, the patient received the 1st dose of Bexsero. On 07-APR-2023, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: 1st dose of bexsero, 2nd dose trumenba). The outcome of the interchange of vaccine products 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: 14-MAR-2023 The physician reported that a patient received a dose of Bexsero followed up with Trumenba.  No symptoms were reported. The reporter did not have date of birth, lot and expiry at the time of report.  The reporter consented to follow-up via any route. The patient received Bexsero and then Trumenba, which led to interchange of vaccine products. This case was linked with case US2023058295, reported by same reporter.; Sender's Comments:  US-GSK-US2023058295:Same reporter/Other patient
Started with slight armpit pain on day 3, increased daily to pain from shoulder, collarbone, whole arm and fingers up through day 8. Called the dr. and was give the ok to take ibuprofen. Took 200mg of ibuprofen on day 8 and pain faded away by day 10.
I had TMJ and visited the Emergency Room on 04/22/2021. It started suddenly and the pain was severe. I took Ibuprofen and it did not respond. It lasted a couple of days and resolved. I had been given exercises by my dentist that helped. I have not had any vertigo for many years, but I experienced Vertigo five weeks after my second dose. I was unable to work on 05/04/2021 and two other days. I visited my doctor and saw an ENT. The Symptoms happen every day but the vestibular exercises that my physical therapist have helped. I  was given a five day course of Prednisone and a medication for dizziness.  I am still experiencing some Vertigo after 13 weeks.
Started with numbness and tingling of right hand ring finger and pinky in April of 2021, falling in June of 2021 due to weakness in lower limbs, dropping things in the same month. Left hand and right hand with numbness and tingling of entire hand, weakness of BLE with multiple falls by June/July with falls increasingly getting worse. I am now using a cane, issues with my sight.
Began to feel tired in afternoon.  Woke from nap and began to vomit several times.  Also malaise, fatigue and feeling feverish even with normal temperature.