chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash red; Hardness injection site; Redness circle; Pain at injection site; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Rash red), VACCINATION SITE INDURATION (Hardness injection site), VACCINATION SITE ERYTHEMA (Redness circle), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache). On 18-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Rash red), VACCINATION SITE INDURATION (Hardness injection site) and VACCINATION SITE ERYTHEMA (Redness circle). The patient was treated with HYDROCORTISONE at a dose of bid. On 11-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache) had resolved. On 19-Feb-2021, VACCINATION SITE INDURATION (Hardness injection site) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash red) and VACCINATION SITE ERYTHEMA (Redness circle) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also included Ice.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up was received on 26 May 2021 included outcome of the event was updated and patient denied follow up.
terrible tinnitus after receiving your vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event in two patients. This is the first of two reports. A male patient of an unspecified age reported that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknow date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. After receiving the vaccine the patient experienced terrible tinnitus in 2021. The patient has been to the doctor 3 times including an ENT visit. The reporter told CDC and they don't care. The doctors just shrug. It's now been 5 months with no improvement. Actually the event has worsened.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) :PFIZER INC-202101102283 Same drug/AE, different patient
Pt received VARIVAX on 2/10/18 after delivery of child while in hospital due to non-immune varicella status on prenatal labs. Pt seen in the office on 2/26/18 due to having developed pruritic skin lesions on back, chest wall, face, and arms. Lesions had erythematous base with vesicular appearance. Pt denied fever, rhinorrhea, or cough.
adult dosage vs the pediatric dosage; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 4ea77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received the 1st dose of Engerix B adult (intramuscular) 1 ml and Engerix B Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 details were provided as follows: The reporter was the phaarmacy tech. The patient received dose of Engerix B in the left arm. The 18 years old patient was given the adult dosage of Engerix-B versus the pediatric dosage, which led to overdose. It was the first shot in the series and the patient was now asking how to proceed with the series. The patient was not experiencing any side effects at this point from the overdose. The overdose was realized when the patient called to reschedule her second dose. The reporter did not consent to follow up.
Temperature to 102 night of immunization lasting about 36 hours, mother perceived pain and swelling testicles 48 hours later.
BURNING IN THE INJECTION SITE (RIGHT DELTOID).  PATIENT DESCRIBED AS HOT OR BURNING; USED SPILLING COFFEE ON YOURSELF AS AN EXAMPLE.  STARTED IMMEDIATELY AFTER INJECTION.  NO REDNESS OR SWELLING VISIBLE.
NOT FEEL GOOD FOR A FEW DAYS AFTER RECEIVING THE BOOSTER SHOT; This spontaneous report received from a parent concerned a male of an unspecified age, race and ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. On an unspecified date, following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient experienced a feeling of malaise and just didn't feel right (Dose number in series: 1). The patient recovered from a feeling of malaise and just didn't feel right. On an unspecified date, the patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported On an unspecified date, the patient not felt good for a few days after receiving the booster shot (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feel good for a few days after receiving the booster shot was not reported. This report was non-serious. This case, involving the same patient is linked to 20220407558. This case, from the same reporter is linked to 20220406074.
This spontaneous report as received from a healthcare worker/certified medical assistant refers to a patient of unknown demographics. Approximately in September 2015 (reported as within the past 2 weeks) the patient was vaccinated with improperly stored GARDASIL (lot # K005881, expiry date: 14-JAN-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to MARRS# 1509USA014899 (same reporter link). Additional information is not expected as the reporter did not wish further contact.
Sore Army near injection site; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL1284) via an unspecified route of administration on arm left on 09Jan2021 07:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient previously took acetylsalicylic acid (aspirin) and experienced allergy. The patient was not diagnosed COVID prior vaccination. The patient was not COVID tested post vaccination. The patient experienced sore army near injection site on 10Jan2021 with outcome of recovering. No treatment received for the event.
Pt. was given a DTaP instead of Tdap. No adverse rxn, pt. was adequately immunized.
Post injection of 2nd COVID-19 Pfizer dose, pt suddenly vomitted (15 min post injection), had uticaria of arms and legs (30 min post injection), and asthma like symptoms such as wheezing, SOB (35min post injection). Diphenhydramine 50mg PO given and pt transferred to ED for observation. In ED, pt received albuterol 0.083% neb, diphenhydramine 25mg IV, famotidine 40mg IV, hydroxyzine 25mg PO, Duoneb 3mL, and Solumedrol 125mg IV. All reactions resolved prior to ED discharge several hours later.
Initial unsolicited report received from consumer on 12 Oct 2017 and live follow up received on 12 Oct 2017. This case involves 79 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH-DOSE (Frequency: once, batch number: UI840AA and expiry date was not reported) intramuscularly in right deltoid on 08 Oct 2017. Patient had seasonal allergy to allegra D and concomitant medication were not reported. On 10 Oct 2017, Tuesday night, 48 hours post vaccination, patient had woke up with her left eye swollen, bloodshot, and her left cheek was puffy and her right eye eventually got that way as well (had a reaction). On 11 Oct 2017, Wednesday morning three days post vaccination, patient's left eye was oozing puss and he was having swelling above and eye. It was like something was in her eye (woke up with problems) and then that night right eye started getting this way with lots of puss and pain. On an unspecified date, post vaccination, she had a temperature last night and some chills. She look so swollen with both her eyes and it hurts to blink eyes. Patient was diagnosed with conjunctivitis. Patient was evaluated 12 Oct 2017 and diagnosed with allergic reaction to something. It was reported that her husband got the same shot and did not have a reaction. Laboratory investigation was not reported. Patient was treated with Cipro eye drops. Patient continued to eye drops and applied ice packs to swollen areas. Outcome of events was not reported. List of documents held by sender: none.
My mother passed away less than two days after the covid vaccine. She had it on April29th and died on May 1.
Rash, swollen tongue and 2 seizures.  Admitted to hospital with diagnosis of seizure and allergic reaction.,
This case was reported by a lawyer and described the occurrence of toxic effect of mercury and its compounds in a male child who was vaccinated with ENGERIX-B (GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 30 March 1998 the subject received 1st dose of Engerix-B (10 mcg, intramuscular). During the first 15 months of life, on or after 30 March 1998 and on or before 15 July 1999, the subject also received vaccinations with RECOMBIVAX, TriHIBit, ACEL-IMMUNE, HibTITER, and MMR II vaccine. According to the legal complaint, the subject was subjected to very high doses of mercury from thimerosal-containing vaccines during the first 15 months of life. As a result of the mercury contained in the thimerosal-containing vaccinations, the subject suffers from neurological and immunological damage with symptoms including developmental delay, loss of language, and failure to meet certain social and motor milestones. The outcome of the events was not reported.
A non-serious spontaneous report of "50 year old got H1N1 LAIV yesterday" was received from patient's friend/non healthcare professional concerning a 50-year-old female. The patient received H1N1, Intranasal on 11-Nov-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Dose received 0.3ml  instead of 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Dose received 0.3ml  instead of 0.25 ml) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FK9894, 939906 and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Nystatin).   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 18-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Dose received 0.3ml  instead of 0.25 ml). At the time of the report, ACCIDENTAL OVERDOSE (Dose received 0.3ml  instead of 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 16-Jun-2021, moderna vial (lot 032B21A) were delivered at refrigerator temperature.  The reporter stated that the office was unaware that vial was not shipped frozen and staff put vial back into freezer when arrived on morning of 16-Jun-2021.  Transport temperature was between 2 to 8 degrees Celsius for couple of hours. Vial was then set out on 27-Aug-2021 to thaw for one hour to room temperature.  Dose of 0.5 ml then given to patient on 27-Aug-2021.  Per moderna one re-freeze was ok, but can not be given beyond 30 days. This dose was beyond that time.  Patient had no signs or symptoms of any adverse reactions to the injection given.  No treatment medication were provided.  Patient did not seek medical care.   This case was linked to MOD-2022-539687 (Patient Link).
5=20-2021 CC:  fever, vomiting, nausea, diarrhea/ Pt c/o nausea, vomitting, diarrhea, and Fatigue for 3+weeks. 5-20-2021 HPI: pt with c/o fever, chills, + nausea, + vomiting; pt has completed her Pfizer COVID vaccine series on 3/21/2021; sx started about 3 weeks ago.  Daughter and husband, both unvaccinated, were diagnosed with COVID.   As of 5-26-2021, pt is doing better. All symptoms, except for diarrhea and nausea have resolved by now.
Vomiting Information has been received from a physician concerning a pediatric patient who in approximately March 2006, was vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). The physician reported that in approximately March 2006, the patient experienced vomiting for one full week following vaccination with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Unspecified medical attention was sought. Subsequently, the patient's vomiting resolved. Additional information has been requested.
Patient fainted 5-10 minutes after the shot. He was seated and fell to the floor. Pharmacist came out immediately to ask him if he had labored breathing. He laid flat on the floor claiming he was dizzy. I called 911 and they took him by ambulance to the hospital
Information has been received from a pharmacist concerning an adult male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt experienced a severe reaction of his arm. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. It was reported that the patient was vaccinated with expired PNEUMOVAX23 (lot # (669382/1490Z), exp 14-AUG-2012) on 15-AUG-2012 (route was unspecified). No adverse effect reported. The outcome of patient was unknown. Additional information has been requested.
pt recv vax approx 5-10min later, dark red to purplish rash devel over lt deltoid which gradually spread upward to face, neck, ears & back;ice applied x 30min w/gradual resolution;referred to PMD;
Every four or five days for the past month I broke out with an itchy place or places on my limbs. First on the left elbow and left foot, then right elbow, then left elbow again and left calf,  then right elbow again, then right thigh and right calf, then right upper arm.
This is a non-serious spontaneous case initially received from a pharmacist on 06-Dec-2018, concerning a female patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [anatomical location: arm (reported as opposite arm), dose, route of administration, batch number and expiry date: not reported] for an unknown indication. On 15-Nov-2018, the patient was administered non-company suspect vaccine PNEUMOVAX 23 (anatomical location: arm, dose, route of administration, batch number and expiry date: not reported] for an unknown indication]. On an unspecified date after vaccination, the patient developed redness and swelling which spread to the elbow area. On an unspecified date, the patient treated the events with ice and TYLENOL. The outcome of the events was not reported. Non-significant follow up received on 17-Jan-2019 from the Medical Information: It was reported that the medical information team was not allowed to contact Merck. So no new information was received. Medical information reference number (SEQ19-00346) was added in the additional information tab. No changes were done in the narrative. Reporter's Comments: A female patient of an unspecified age developed redness and swelling which spread to the elbow area, on an unspecified date after vaccination with INN Flu Vaccine Seasonal and non-company suspect vaccine PNEUMOVAX 23. The company assessed the causality of the events as unassessable due to the lack of onset latency of the events.
Two days after vaccine received, developed fever, chills, trouble breathing. Went to Urgent Care center. Treatment-nebulizer and IM steroid injection. Currently has pneumonia.
issues with heart rate; issues with blood pressure; 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 HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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) 1 dosage form. On an unknown date, the patient experienced HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure). At the time of the report, HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure) 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 products were reported. No Treatment medication were reported.
Second day after vaccination patient started complainin of left hand burning sensation to skin and sensitivity, today, day 4 s/p vaccine she is complaining of entire arm soreness, burning, and sensitivity.  Her skin is very sensitive to cold, water, and touch.
Flu like symptoms; Injection site itching; Sore arm with Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Sore arm with Covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Sore arm with Covid vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Sore arm with Covid vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided. The reporter's causality for the events of Flu like symptoms, Injection site itching and Sore arm with Covid vaccine with Humira (adalimumab) Solution for Injection was not provided.   Reporter did not allow further contact
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm 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's relevant medical history included: "stroke", start date: 2015 (unspecified if ongoing), notes: Prior stroke in 2015. Concomitant medication(s) included: XARELTO taken for anticoagulant therapy, start date: 05Aug2015, stop date: 26Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "recovered" (16May2022) and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) positive; (02May2022) negative, notes: Took 3 more antigen tests over the next 5 days (all negative); (10May2022) positive, notes: Antigen test positive again for an additional 6 days; (16May2022) negative, notes: Finally negative again on Day 20. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: If vaccine received: Yes, Other medication in 2weeks: Yes. Adverse event: Rebound of symptoms and positive COVID test on Day 14. Initially tested positive (antigen plus PCR) on 26Apr. Took Paxlovid for 5 days. Tested negative on antigen test on 6th day (02May). Took 3 more antigen tests over the next 5 days (all negative). Symptoms returned on Day 14 (10May). Antigen test positive again for an additional 6 days. Finally negative again on Day 20 (16May). Known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
devel high BP 170/106 & 160/100 which lasted for 15 days, high pulse rate between 95 to 100 & while working it was more than 140/min, constant h/a, feeling discomfort when walking legs disbalanced;trembled, sleepless noc, uneasy, shoc
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions reported. On 11-APR-2014, the patient was inadvertently vaccinated with RECOMBIVAX HB (dose, strength and lot number not provided). No co-suspect or concomitant therapies were reported. The reporter stated that RECOMBIVAX HB vaccine had been improperly stored. At the time of the report, the outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Blood clot in left leg requiring emergency room ultrasound and medication as well as doctor follow up. Physician asked me to report this to you because patient has not had any illness or condition related to this in the past and only happened after covid booster