chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effects worse with the second vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects worse with the second vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects worse with the second vaccine). At the time of the report, VACCINATION COMPLICATION (side effects worse with the second vaccine) outcome was unknown.            No concomitant medication was provided.  No treatment medication was provided.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, pressure issue with ZOSTAVAX cause medication to get in the patient's eye. The patient sought medical attention- was at doctor's office at the time of the event. Product quality complaint (PQC) was involved. Additional information is not expected as there is no reporter or physician contact details available.
This spontaneous report was received from a Licensed Practical Nurse refers to a 4 month old patient (unknown gender). On 24-FEB-2014, the patient was inadvertently administered with one dose of VAQTA, intramuscularly. No adverse effects reported. This is one of 2 reports from the same reporter. Additional information has been requested.
Several hours post vaccine I was feverish, had severe headache and arm began to become red.  I also became nauseous.  The redness on arm continued to become larger, redder and itchy.  The location of this lesion was beneath the injection site (about three inches ) .  The injection site itself was just slightly sore to the touch but the large red, swollen, itchy area continued to enlarge, my headache remained, nausea remained and I have had no appetite.  My temperature was about 100 degrees for days, it was normal last night and today.
Extensive spreading erethematous area surrounding vaccination site about 6 by 12 cm, along with generalized painful lymphadenopathy. We had 2 other patients vaccinated on the same day that had similar reactions that were much more severe than any of the prior 40 people that we vaccinated at the command. All recovered without any sequelae.
I noticed a large (maybe the size of a nickel) bruise at the vaccination site; Left arm is black and blue at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Left arm is black and blue at injection site) and VACCINATION SITE BRUISING (I noticed a large (maybe the size of a nickel) bruise at the vaccination site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to some Antibiotics), Age-related macular degeneration since 1980 and Premature atrial contraction since 1970. Concomitant products included ESTRADIOL (ESTRADIOL TRANSDERMAL) for Estrogen, PROPAFENONE and ATENOLOL for Premature beat atrial, ACICLOVIR for Viral infection.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Left arm is black and blue at injection site). On an unknown date, the patient experienced VACCINATION SITE BRUISING (I noticed a large (maybe the size of a nickel) bruise at the vaccination site). On 11-Apr-2021, VACCINATION SITE HAEMORRHAGE (Left arm is black and blue at injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (I noticed a large (maybe the size of a nickel) bruise at the vaccination site) outcome was unknown.            No treatment medication was provided. Eye vitimain was used as concomitant mediacation. The action taken with mRNA-1273 with the event was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on contains significant information. Address, Demographic details, medical history, concomitant medications, dose 2 details updated. Added Event  Vaccination site hemorrhage start date and stop date, outcome were updated and new event was added.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # M011832 with expiration date 25-JAN-2018 orally (dose, frequency and dose number were unspecified) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. It was stated that the temperature excursion was between 32 and 36 Fahrenheit degrees for a time frame of 14 hours and that there were no previous temperature excursions or digital data logger involved. Additional information has been requested.
around 7;30PM 3/30/2021 after my second covid vaccine  I started having burning around my mouth and then my left arm went numb. my doctor had me on Benadryl but by next day the medicine wasn't working. April 1 I felt like my throat was swollen and my DR gave me 5mg of prednisone and then I took Benadryl and it made me worst so I had to go to ER. upped prednisone to 50mg. had red burning rash on face and neck. they sent me home at like 9:30PM , next morning it felt like the tongue and throat are swollen went back to er and they sent me home even though it felt like my throat was on fire and I had a rash. ER told me to stop Benadryl .  went to allergy DR to see if I was allergic to something in vaccine but couldn't do anything until a month later.  had to be put on special diet and shots and I was having heart issues because of pepcid .  I'm under care of heart doctor
Woke up with throat feeling hoarse on 1/27/12.  Periodic laryngitis by afternoon of 1/28/12.  Full laryngitis by evening of 1/28/12.  No other symptoms other than tightening of throat if attempting to talk too much, but throat will relax again within 5-10 minutes if I stop trying to talk.
Hour or so after vaccine felt numbness on one side of face and jaw, increasing as time went by, felt exactly like getting local anesthetic at dentist, touched with hand and had no sensation, muscles not responding, completely numb.  Went back to pharmacy and they told me to sit there for a while and gave me a bottled water.  I went home after about 20 minutes as symptoms did not get worse and no other symptoms developed (other than feeling light-headed and a bit unsteady).  Symptoms went away by early evening, and feeling slowly returned to my face.
Rt deltoid - area of erythema 3x3.5 cm. Lt deltoid - area of erythema 8x5 cm - warm swollen. Tdap given in Rt deltoid. Meningitis given in Lt deltoid.
Ate food immediately after first dose and took some doses with coffee; Spontaneous report received on 16JAN2020.  A male consumer reported that he "ate food immediately after first dose and took some doses with coffee" (PT: Product administration error) while being on Vivotif capsule for immunisation. The consumer stated that, he took the first dose of Vivotif and ate food immediately afterwards. He also took some doses of Vivotif with coffee. He had completed the course of Vivotif on 16JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer ate food immediately after taking first Vivotif dose and also took some Vivotif doses with coffee (drug administration error). Vivotif dose should be taken one hour before a meal with cold or luke-warm water. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer ate food immediately after taking first Vivotif dose and also took some Vivotif doses with coffee (drug administration error). Vivotif dose should be taken one hour before a meal with cold or luke-warm water. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.
Felt achy; He had the chills; Tired overnight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), CHILLS (He had the chills) and FATIGUE (Tired overnight) in a 35-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Felt achy), CHILLS (He had the chills) and FATIGUE (Tired overnight). At the time of the report, PAIN (Felt achy), CHILLS (He had the chills) and FATIGUE (Tired overnight) had resolved.            No concomitant medications were reported.  Treatment information was not provided. Patient received Moderna vaccine and after the second shot, he had chills, felt achy and tired overnight. Patient was fine the next day.
Projectile vomited up to 20 times a day.  I laid in bed two months almost immobilized unable to handle light or noise.  My body would go into sweating fits and had extreme BP readings on and off a month.  I stupidly waited 2 or 3 weeks and was told not allowed to go to Doctor, was told and ignored a few more days the scariest health issues in my life.  I still to this day have the feeling my brain has pressure.  I have almost never been sick for 20 years.  Went to hospital twice locally,  I was literally told on the 2 nd date at the hospital that I should not mention the Johnson and Johnson vaccination.  I was told people think they can sue and make money.  I never lost more faith in our health care system.  Here I took one for the team got vaccinated then treated criminal like I was a con artist trying to sue J and J.  In case CDC lacks nuisance let me clarify this is an unethical way to approach that involves a positive feedback loop of Bias!  I am very stubborn, so stubborn my head popped a few days after the vaccination.  I was running on a treadmill went straight down.  I thought I was having a stroke at first.  I wasn?t sure but didn?t want insane hospital bills.  So I tried many interventions.  Potassium, diuretics, didn?t eat for a couple of weeks which seemed to help.  I had several BP readings like 190/100 BP, double vision, only intervention besides what I mentioned is I constantly had ice on my hea?. I am filling this out and VAERs complains I am timing out?
Severe (R) thigh swelling, redness, induration, pain. Pt was exquisitely tender and induration and redness 6 cm x 7 cm. Red line 3cm long also developed lateral to immunization site. Treated with TYLENOL, ice. 6 cm x 7 cm are resolved, red line 1mm thick, 3 cm long persists.
81 y.o. male with PMH of CAD, HLD, obesity, OSA, hypothyroidism, SLE, diastolic heart failure did evaluate disease, type 2 diabetes on insulin with neuropathy and nephropathy, CKD 3, hypertension, GERD, previous CVA, chronic cholecystitis, and COPD who presents to the emergency room due to complaint of diarrhea and weakness.   Ended up testing positive for COVID while admitted on 4/4/22.
ADMINISTRATION ERROR : Previously 11/30/2020 received DTaP +IPV, Re-administered 08/10/2021. No noted symptoms.
she noticed a small rash about the size of the bottom of a normal tea glass. It was located an inch below the site of injection; It was swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she noticed a small rash about the size of the bottom of a normal tea glass. It was located an inch below the site of injection), VACCINATION SITE SWELLING (It was swollen) and VACCINATION SITE ERYTHEMA (red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE RASH (she noticed a small rash about the size of the bottom of a normal tea glass. It was located an inch below the site of injection), VACCINATION SITE SWELLING (It was swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE RASH (she noticed a small rash about the size of the bottom of a normal tea glass. It was located an inch below the site of injection), VACCINATION SITE SWELLING (It was swollen) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information was received on 29-Apr-2021 content no new information.
Red; Silver dollar size bump; Silver dollar size bump; Painful; This case was reported by a nurse via sales rep and described the occurrence of erythema in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a week after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced erythema, skin discoloration, local swelling and pain. On an unknown date, the outcome of the erythema, skin discoloration, local swelling and pain were unknown.   It was unknown if the reporter considered the erythema, skin discoloration, local swelling and pain to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. 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: 02-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient was a retired nurse. The reporter stated that the patient received Fluarix vaccine and after that she experienced red, painful and silver dollar size bump. The reporter agrees to follow up from GlaxoSmithKline.
Approximately 19 hours after the injection I began to feel achy and had a fever (99.8-100.8 oral) throughout the rest of the day and evening, including right before I went to bed. I felt chilled for about 4 hours in the afternoon, especially in my legs and feet and was tired. I slept most of the afternoon. The following morning I was fever-free and felt normal. Two days after the vaccine (3/15) I noticed I have a red spot(about 1 inch) on my upper arm, near the injection site. The area is tender but does not itch.
Temperature was up to 104.5. It came down to 103.6 after two Tylenol 1.5 hours later.
REDNESS, WARMTH, SWELLING, AND DISCOMFORT IN LEFT DELTOID WHERE CLIENT RECEIVED PNEUMOVAX.  LARGE AREA OF REDNESS NOTED BELOW INJECTION SITE. EVALUATED BY PHYSICIAN.
Initial reaction of muscle soreness which subsided over 2-3 days, but eventual full body sensation of being hot/sweaty without measured change in body temperature through thermometer. The overheating occurred for 3 days before beginning to subside. It was accompanied by some slight chest pain on day 5 post-vaccine, which has also mostly subsided.
Information regarding Prevnar vaccine was received from a consumer, the mother of a 16-month-old female patient who on 21-Dec-2006, received a dose of Prevnar along with a dose of Hib (manufacturer unknown), a dose of Varivax (manufacturer unknown), and a dose of M-M-R II (Merck Sharp & Dome). On the same day, the patient experienced lethargy, possible seizure, irritability, was not acting normally, had jerky movements and clenched hands. On 22-Dec-2006, the child would not respond and on 24-Dec-2006, the child died. On 21-Dec-2006, the patient with a history of influenza like illness, pyrexia, virus (unspecified) and tremor of hands, was evaluated at the physician's office for those symptoms and was also administered Prevnar along with Hib, Varivax, and M-M-R II. Later that day, the child was lethargic and experienced a possible seizure, irritability, was not acting normally, had jerky movements and clenched hands. On 22-Dec-2006, child would not respond and was taken to the hospital and placed on life-support for two days. On 24-Dec-2006, the child died. The cause of death was not reported. The reporter stated she "feels that her daughter had an adverse reaction to Prevnar." No additional information was available at the time of this report.
Information has been received from a pharmacist concerning a 70 year old female with an allergy to penicillin who on 18-JUN-2010 was vaccinated SQ with a single dose of ZOSTAVAX (Merck) (lot # 665514/0145Z) at the pharmacy. On 19-JUN-2010 the patient developed itchy, fluid-filled blisters on the backs of both thighs and on one arm. The patient self-treated with BENADRYL cream topically with slight improvement in symptoms. There were no laboratory studies performed. the patient sought medical attention by calling pharmacist. At the time of report, the patient had not recovered. Additional information has been requested.
Info has been received through the mfr pregnancy registry from a 44 year old female who in 11/93, was vaccinated with an "adult dose" of varicella virus vaccine live while she was 8 months pregnant. Subsequently, on 11/26/93, she reported a breakthrough of chicken pox. The report indicates "blood test" for lab diagnostics studies performed. Unspecified medical attention was sought. There was no concomitant medication. Outcome unknown. There was no product quality complaint involved. Follow-up info has been received from a nurse indicating that the pt's office does not administer varicella virus vaccine live and they only draw titers for serostatus. If the pt needed the vaccine they would be referred to the pediatrician's office. The reporter also indicated that they would not have treated the pt if she was pregnant and that she would have been obtaining care from her prenatal physician. Additional info is expected.
On 4/20/18, pt went to school nurse complaining of pain in right leg. There was a large area of redness. Mom picked him up and he complained of difficulty walking. Used ice pack and pain improved. On exam, approximately 22 cm oval area of erythema, feathery border, W/O induration. BENADRYL given for 1-2d and did well.
Cold; Chills; temperature of 99°F.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jan2022, outcome "unknown", described as "Cold"; CHILLS (non-serious) with onset Jan2022, outcome "unknown", described as "Chills"; BODY TEMPERATURE INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "temperature of 99°F.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Consumer reported for his granddaughter (patient) that received the First dose of Pfizer BioNtech vaccine yesterday and ever since the patient has had Cold, Chills and a temperature of 99°F. They went yesterday at 5:00 for the patient to get the vaccine and she has been cold all day. Reporter wants to know if these side effects could be from the vaccine. He also mentioned his 7year old Grandson had received the vaccination as well but he does not have side effects. He would like to know on how to treat the fever, is monitoring and sponge bath every hour enough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received Two Doses of Heplisav-B At The Same Time; Initial Report Received on 28-Feb-2023  A registered pharmacist in the reported that a 34-year-old patient (gender, race, and ethnicity unknown) received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization at the same time in a combined dose.  Medical history was unknown and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On an unknown date, the patient received two doses of HEPLISAV-B vaccine (Lot # 937230, expiration date Sep-2023, NDC # 4352800305) at the same time in a combined dose intramuscularly (injection site unknown). The person administering the vaccines misread the prescription and combined two doses of HEPLISAV-B into one prefilled syringe and administered them to the patient. No adverse reactions were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pt presents with nausea, body shaking, dizziness and L arm tingly beginning today at 1000 today. 3 days post vaccination
Caller would like to report post vaccination adverse events; 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 VACCINATION COMPLICATION (Caller would like to report post vaccination adverse events) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Caller would like to report post vaccination adverse events). At the time of the report, VACCINATION COMPLICATION (Caller would like to report post vaccination adverse events) outcome was unknown.        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 medication was provided. No treatment information was provided.