chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid test result Positive; covid test result Positive; The lymph node under my left arms was swollen a few days after the 2nd vaccines. It was about the size of a golf ball. It hard to touch and rolling. It went away in one week; This is a spontaneous report from a contactable Pharmacist. This (Age: 47; Unit: Unknown) female Pharmacist reported that the patient received second dose of BNT162B2 ( Lot number: EL 3249) via intramuscularly in left arm on 14Jan2021 15:00 and the patient received first dose of BNT162B2 (Lot number: EL 1284) via intramuscularly in left arm on 28Dec2021 15:00 both as a single dose for covid 19 immunization. The patient has not received any other vaccine within four weeks and no any other medication within two weeks. The patient's concomitant medication and medical history was not reported. No known allergies reported. Patient had no covid prior vaccination and tested to covid post vaccination. On 16Jan2021 the patient's lymph node under her left arms was swollen a few days after the 2nd dose vaccine,It was about the size of a golf ball, It was hard to touch and rolling, and It went away in one week. On 02Feb2021, the patient was tested NAA, RT-PCR (nasal swab) and tested positive for covid 19. No treatment was received. The outcome this event was reported as resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the eve and the suspect vaccineBNT162B2
Itchy Rash to arms, legs, stomach, & back. Pt seen by Dermatologist on 5/17/12 & she prescribed Atarax, clobelisol, & Claritin.
Immediate pain in shoulder. Pain persisted with difficulty in range of motion of shoulder starting 2 weeks later.
Patient contracted COVID-19 after receiving two doses of Pfizer vaccine. Date of admission approximately 10 week post vaccination. Dates of vaccination unable to be verified as City Immunization Record unable to match with patient. Patient was vaccinated at the a facility. Patient was admitted on 3/31/2021 with ~ 4 days of cough and decreased appetite, found to be COVID positive with pneumonia. Patient received supplemental oxygen, decadron and completed a course of remdesivir. She has improved clinically and was discharged on room air.
first dose 14-SEP-2018, second dose had not been given; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Pt given vaccine in the morning at 8:45 am. At 10:30 am mom called he was unsconsolable/crying. At 1:30 pm called fever 103.2. No redness at sight.
Received senior flu shot, FLUZONE High-Dose 2017-18 0.5ml SYR and 3. hours later developed severe shivers and feeling of cold and felt nauseous for about 5 hours with a slight fever. Called doctor and checked for inflammation at injection site, there was none. Had no appetite and remained bedridden and exhausted for about 24 hours. Returned to normal. I am a 73 year old female.
This case was reported by a other health professional via call center representative and described the occurrence of leg pain in a 16-year-old male patient who received BEXSERO (batch number 15C601, expiry date 31st October 2017). Concomitant products included bupropion SR and topiramate. On 13th September 2016, the patient received the 2nd dose of BEXSERO. On 13th September 2016, less than an hour after receiving BEXSERO, the patient experienced leg pain, chills, pallor, headache and nausea. On 13th September 2016, the outcome of the leg pain was recovered/resolved. On an unknown date, the outcome of the chills, pallor, headache and nausea were not recovered/not resolved. It was unknown if the reporter considered the leg pain and headache to be related to BEXSERO. The reporter considered the chills, pallor and nausea to be possibly related to BEXSERO. Additional details were reported as follows: The concomitant medication included topiramate (25mg which patient took on the day of vaccination in morning) and bupropion SR (100mg but did not take on the day of reporting). The health care professional stated that patient had no reaction to first dose of BEXSERO. The patient received the vaccine and then left the physician's office. The patient came back 30 mins later stating about pain in the leg that traveled up body to head. The reporter stated that blood pressure was normal.
Extreme fatigue, body aches, headache, coughing, sore throat, tickle in throat, postnasal draining/ runny nose, slight vertigo (the first shot was worse), fever (highest was 99.9 then took Advil. A lot of these symptoms are the same as my possible Sjogren's and my daily low-grade fevers, it's just that these are worse.  The body aches and fatigue was present when I awoke shortly before 7 am, by about 3 pm the sore/ticklish throat and coughing started along with the postnasal drip/runny nose. The headache started at around 6 pm. It is now Wednesday, and everything is still going on.
Breakthrough case admission after 3 vaccines Moderna 1/2/21 lot# 011L20A;  Moderna 1/29/21 lot# 004M20A;  Moderna 11/11/21 lot# 077C21B
pt recv vax 3OCT95 & lab eval on 6FEB96 revealed a negative measles titer;
Initial report was received from a health care provider on 09 January 2008.  A 55-year-old male patient with no pre-existing medical history, had received an intramuscular left deltoid injection of TYPHIM VI, lot number A0394-2 and an intramuscular left deltoid injection of HEPATITIS A vaccine, lot number AHAVR195AB (manufacturer not reported) on 28 November 2007 and an unspecified amount of time later, he developed weakness in the triceps and soreness to touch in the left arm.  The discomfort was more intense with exercise.  The patient had not received any other vaccinations during the four weeks prior to immunization.  Corrective treatment included MORTRIN, with no relief.  At the time of the report, the patient had not been evaluated by a health care professional and had not recovered from the event.  Follow-up information received from a health care provider on 14 July 2008.  A corrected lot number for the HEPATITIS A vaccine was reported as AMAVB195AB.  Adverse event onset date was 29 November 2007.  Muscle weakness in the left triceps was confined to the injection site.  One month after the vaccinations, the patient had no improvement in muscle weakness and was not able to perform his usual workout routine of pushups and triceps exercises.  The patient did not see a physician and did not receive any treatment.  The patient eventually recovered four months later.  The patient estimated that the muscle weakness resolved on its own by March 2008.
7 days after getting the vaccine a rash /hives developed on my right arm. it got worse and it is now probably my whole shoulder down to halfway down my upper arm. there is also rash on the left arm but much smaller and barely noticeable where I got the shot. I just started taking an antihistamine cirtizone/generic Zyrtec. I feel fine no symptoms besides the rash.I am reporting it because I didn't know if the cortisone injections would have had some impact that the rash is mainly on the opposing arm.
FOR 4 DAYS FOLLOW VACCINE. EXPERIENCED SAME SYMPTOMS FOLLOWING FIRST  SHINGRIX INJECTION. Fever & NAUSEA; FLU-LIKE SYMPTOMS
Numbness in face 10 minutes after injection. This lasted 15 minutes but has returned intermittently since vaccination.  Intermittently have had some rashes and itching on neck and torso.
About 8 days after my first Moderna vaccine, I started having an itchy arm, then redness, and a large rash that was about the size of a credit card.  It has since gotten about 1.5 times bigger, and after 5 days seems to be subsidizing.  I put nothing on it and took a few Advil and Tylenol.  I was really afraid because I didn?t know there would be such a delayed side effect and such a large rash/red/itchy area.
pt received moderna bivalent vaccines on 6/6/23 and 7/11/23 (10mcg, pink cap) for primary series.  should have received higher dose of moderna bivalent vaccine (25mcg, blue cap) for both doses instead.  no symptoms reported.  error noted on 7/18/23 after chart review.   I called moderna for guidance, and was directed to call . Recommended pt receive a doses of the moderna bivalent vaccine (25mcg, blue cap) since lower than recommended bivalent dose previously received. no minimum time interval required for the first dose. family notified.
sx started approximately 2 wks after first:  chest tightness and into throat almost constant accompanied by shortness of breath especially with any exertion (going up steps).  Very irregular heartbeat (PVCS) resulting in complete cardiac workup.  Chest tightness lasted approx 1 month with sx gradually decreasing over approx 2 months
This spontaneous report as received from a healthcare worker (reported as medical assistant) refers to a 7 month old patient of unknown gender. Pertinent medical history was unknown. It was reported that due to human error a medication error occurred resulting a 7 year old patient received one dose of GARDASIL (dose, route of administration, anatomical location and lot number was unknown) on 20-FEB-2015 (inappropriate schedule of drug administration). Concomitant medications were unspecified by reporter. It was clarified  that there was no labeling or product confusion happened. No adverse effects were reported. The outcome of the events was unknown. The causal relationship between the events and GARDASIL was not reported. No additional information was reported. Additional information has been requested.
This infant had a fever, difficulty breathing, non0responsive body jumping, convulsion, wheezing. Treatment - ER room, medical follow up.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.)-
significant level of pain in the left hemisphere of the head/pain had gotten progressively worse; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL9264), via an unspecified route of administration, administered in the left arm on 09Feb2021, 09:00 (at the age of 76 years old) as second dose, single dose for COVID-19 immunisation. Medical history included atrial fibrillation (reported as Afib) controlled by medication. The patient had no known allergies and was not pregnant by the time of the report. Concomitant medications included sotalol, rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR), montelukast sodium (SINGULAIR), loratadine (CLARITIN), and Aci (as reported). The patient previously received the first dose of BNT162B2 (Lot number: EL3302), administered in the left arm on 19Jan2021, 09:00 (at the age of 76 years old) for COVID-19 immunisation. Approximately five days after second shot (13Feb2021), the patient experienced significant level of pain in the left hemisphere the of head and reported that the pain had gotten progressively worse. The event resulted doctor or other healthcare professional office/clinic visit; she had seen a dentist, an ENT, and a primary physician. No signs of dental, sinus, or other problem, and the patient was being treated for neurological reaction. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Therapeutic measures were taken as a result of the event and included treatment with prednazone (as reported), then gabapentin, and currently carbamazepine. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
26NOV91 pt recvd 1 dose of Engerix-B & 16JAN92 elevated liver enzymes were detected; no tx given outcome pending;
SARS-CoV-2 test positive; COVID-19; Sore right arm; sinus problems; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUS DISORDER (sinus problems), COVID-19 (COVID-19), VACCINATION SITE PAIN (Sore right arm) and SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced SINUS DISORDER (sinus problems) and VACCINATION SITE PAIN (Sore right arm). On 11-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive). At the time of the report, SINUS DISORDER (sinus problems) and SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) outcome was unknown and COVID-19 (COVID-19) and VACCINATION SITE PAIN (Sore right arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information received: Patient had declined further follow-up.; Sender'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.
This spontaneous report as received from the patient's mother via a pharmacist refers to a currently 4-month-old male patient. The patient had no pertinent medical history, drug reactions or allergies or concomitant therapies. On 21-NOV-2018, the patient was vaccinated with the first dose and on 03-DEC-2018, with the second dose of ROTATEQ lot # R013289, expiration date: 03-OCT-2019, orally for prophylaxis (exact doses were not reported). On an unknown date, after receiving ROTATEQ, the patient experienced fever (it was unspecified if fever was after the first dose, the second dose or after both doses of ROTATEQ). The fever went away without any treatment within a "few hours." No treatment was given for the event. No lab diagnostics or studies were performed. The relatedness between the event and ROTATEQ was not reported.
TWO DAYS AFTER VACCINE WAS ADMINISTERED, PT PRESENTS WITH RASH TO SITE. C/O WARMTH AND DISCOMFORT TO SITE. SYMPTOMS ARE LOCALIZED TO AREA OF ARM VACCINE WAS GIVEN. MOM ADVISED TO TREAT SYMPTOMS (TYLENOL, ICE, TOPICAL BENADRYL, ETC.). ADVISED TO GO TO ER FOR SOB, SWELLING OF FACE OR TONGUE.
pt recvd vax 24NOV93 either IM or IV & blood was noted int he syringe following the vax; No further details are available
Information has been received from consumer concerning his 13 year old son with no pertinent medical history and no drug reactions or allergies who on 13-MAR-2012, was vaccinated with GARDASIL (dose, route, site of administration and lot number not reported). There was no concomitant medication. The patient's father reported that very soon after receiving GARDASIL, in approximately March 2012, his son has experienced swollen glands in the collar bone and the armpit area. The patient also experienced bloody noses and chest pain. For the chest pain on an unknown date, the patient was taken to the Emergency Room (unknown if the patient was admitted, if admitted, the duration was unknown). The father stated the physician was treating the problem as though it was cancer and stated "the last two weeks have been torture". No treatment was given for the adverse experience. On an unknown date, complete blood count (CBC), complete metabolic panel (CMP), chest x-ray, abdominal x-ray and abdominal ultrasound were performed (results not provided). At the time of the report the patient was recovering (also reported as adverse experience did not improve). Additional information has been requested.
STAGE 4 BREAST CANCER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 17-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had swelling of breast tissues and subsequent finding of stage four breast cancer.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stage 4 breast cancer was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0:20221047274-covid-19 vaccine ad26.cov2.s-stage 4 breast cancer. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT. Therefore, this event(s) is considered not related.
an allergic skin reaction/ coworker had a very similar reaction; several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction; several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction; developed some type of outbreak with little, red marks that looked like water blisters or a bug bite/ coworker had a very similar reaction; allergic reaction/ coworker had a very similar reaction; turned jet black in color/ coworker had a very similar reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (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: SKIN REACTION (non-serious), outcome "unknown", described as "an allergic skin reaction/ coworker had a very similar reaction"; RASH PAPULAR (non-serious), BLISTER (non-serious), outcome "unknown" and all described as "several red bumps on my arm and legs and 2 of them formed water blisters/ coworker had a very similar reaction"; ERYTHEMA (non-serious), outcome "unknown", described as "developed some type of outbreak with little, red marks that looked like water blisters or a bug bite/ coworker had a very similar reaction"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction/ coworker had a very similar reaction"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "turned jet black in color/ coworker had a very similar reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash x 5x5cm on the left thigh - did not look infected, but allergic.
About a week after the vaccination in my left arm, I observed mild erythema and pruritis around site of injection (extending approximately 3-4 cm around the area). Then a few days later, had notable 2 cm diameter axillary lymphadenopathy - palpable, soft and mobile and tender to palpation.
severe swelling in her feet and ankles; insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (severe swelling in her feet and ankles) and INSOMNIA (insomnia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (severe swelling in her feet and ankles) and INSOMNIA (insomnia). At the time of the report, PERIPHERAL SWELLING (severe swelling in her feet and ankles) and INSOMNIA (insomnia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Flu-like symtoms: Day following injection, whole body muscle and joint aches 9:00AM-11AM, shivering 9:00AM-11AM, tiredness 9:00AM-11AM and 5:00PM-8:00PM, stomach upset 6:00PM-7:00PM, injection site sore 3AM-10PM.
No additional AE.; An improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 19-JUL-2022, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliter, lot number W007371 with expiration date 13-JUL-2023, administered for prophylaxis (strength, vaccination scheme, route of administration and anatomical site of application were not provided)  The administered vaccine experienced a temperature excursion at 34.5 fahrenheit (F) for 1 hour 7 minutes 0 seconds. Also, was reported a previous temperature excursion of 66.7 fahrenheit (F) for 13 hours 52 minutes 0 seconds. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005917:MSD US-009507513-2210USA005937: US-009507513-2210USA005929: US-009507513-2210USA005979: US-009507513-2210USA005936: US-009507513-2210USA005916: US-009507513-2210USA005994: US-009507513-2210USA005996: US-009507513-2210USA006007: US-009507513-2210USA005624:
Nurse reporting a GARDASIL 9 was administered to a pregnant woman; No adverse event; This spontaneous report was received from a nurse and refers to a 36-year-old female patient. The patient's medical history, previous drug reaction or allergies were not reported. The patient's concurrent conditions included  gestational diabetes. Her concomitant include prenatal ( manufacture unknown).  On 26-SEP-2022, the pregnancy patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, lot #W010663, expiration date: 11-MAR-2024, administrated as prophylaxis (strength, route of administration, and anatomical site injection were not provided)(exposure during pregnancy). On an unknown date, the patient recovered from the event. Information regarding the date when the patient became pregnant, last menstrual period (LMP), and the estimated date of delivery were not reported. The pregnancy outcome was not provided at the time of the report therefore, the fetal outcome was unknown.
6 months post vax, the pt experienced whole body flushing, day of vaccine the same day of the vaccine which lasted for 12 hours, with generalized itching for 2 days. Treated self with Benadryl.