chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a physician and a 34 year old female who received 1st dose of Lymerix in April, 1999, and 2nd dose in May, 1999, respectively. One day after 1st dose, the pt experienced a fever (102) which resolved. One week after receiving 2nd dose, the pt experienced joint and muscular pain, malaise and stiffness in hands, knees and feet. The pt stated that when the 2nd dose was given, the nurse hit a nerve and she had instant pins and needles to her hands. No treatment was given. The fever resolved. All other adverse events are ongoing. The most recent information, received on 8/18/99, reports that the condition of the pt is ongoing.
A report was received from a healthcare professional on 10/13/2003 concerning a 49 year old female vaccinee who developed a red, hot, painful, itchy injection site, a bumpy rash on her thighs, and she felt agitated and flushed on the day after receiving Fluvirin on 10/10/2003. On 10/11/2003, the vaccinee developed a red, raised, hot to touch, painful, itchy 4-5 inch area at the site of injection, a bumpy rash on her thighs, and she felt agitated and flushed after receiving Fluvirin on 10/10/2003.  The vaccinee was improving at the time of reporting. There was insufficient information to determine the reporter's causality assessmen. Update 1, 03/18/2004: A follow up report was received from a healthcare professional indicating that the vaccinee experienced a raised rash, itching and was warm to touch 12 hours after receiving Fluvirin.  The reporter indicated that the affected arm looked like a burn.  The vaccinee recovered 84 hours later.  The outcome of the events reported initially was not reported. No follow up pending, all information received.
PATIENT CALLED BACK AND SAID SHE HAD DEVELOPED A BLISTER LIKE RASH ON THE UNDERSIDE OF THE ARM THAT WAS IMMUNIZED.  SHE ALSO SAID THAT SHE HAD A BRUISE AND KNOT AT THE INJECTION SITE.
Work up with swollen eyelids in both eyes on 20Feb2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 15:30 (at the age of 42-years-old) (Batch/Lot Number: EN6201) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included known allergies of penicillin from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol/norelgestromin (XULANE) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (Lot number: EL8982) administered in Right arm on 29Jan2021 11:45 AM for covid-19 immunisation. The patient experienced work up with swollen eyelids in both eyes on 20Feb2021 05:00. Treatment for event was recommended to take Claritin and antihistamine eye. Prior vaccination and post vaccination: patient did not tested covid. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Headache, Myalgia, Fever & NauseaVomiting Narrative:  myalgia, nausea, headache, fever, chills
A report has been received from a health professional who was a registered nurse. The report concerns a 35 year old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. The patient received FLUMIST QUADRIVALENT (intranasal) at an unknown dose on 22-Oct-2014. The registered nurse reported that on 22-Oct-2014 during administration the clip came off and the entire contents of the sprayer went into one nostril and dribbled out. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of entire contents of sprayer administered in one nostril and dribbled out was unknown. The report was considered to be non-serious by the reporter.
Shivers, sore arm. Then, on 11/7/13 the patient had a fever of 105 degree F. He went to the hospital and was admitted for 4 days and received IV antibiotics.
DIED; This spontaneous report received from a consumer via a company representative via social media ( concerned a female of unspecified age, race and ethnic origin The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, 01 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  On an unspecified date, the patient was died. The patient was died from unknown cause of death. It was reported as "My mom died 2 days after getting the vaccine." It was unspecified if an autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20220254993-Covid-19 vaccine ad26.CoV-2.s-Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I had headache, scratchy sore throat, nausea, light headedness, diarrhea, cough. I took a home COVID-19 test that came back positive, I called my primary care physician, had a telehealth visit and the PAXLOVID. I started taking the antiviral on March 14, 2023. I did start feeling better and testing negative. I then got rebound COVID-19, March 26, 2023. The cough this time around is much worse the congestion is still here, but I have tested negative.
Vaccine was given at 1620. 5/10 pain in L shoulder began 2000. Pain progressively got worse to 7/10 with movement. Range of motion began to be limited the next morning. Pain was more significant at 7/10. Red rash began to spread from front of L shoulder around the deltoid to the bicep/tricep and is spreading distally. Fever was reported overnight during the second night around 0400am. No fever reported at 0730am when patient reported to work. Rash continues to spread but pain level has decreased to 1/10. Pt has been taking 600mg Motrin every 12hrs since the first night. Pt also has been icing the rash 2x daily.
Patient's mother indicated on consent. form that child had a (12 years old).  Prior to vaccine administration, verbal confirmation of  DOB was given by child.  Upon further investigation, it was discovered that the child's real DOB is 3/3/2010 (11 years old).
After the Dtap, Hepatitis B, IPV shots and Flu Shots, patient was diagnosed with a development delay which after evaluations was further defined/diagnosed as autism; before the vaccines; she appeared to be a normal healthy infant.  11/9/07 Received vax records from pcp.  No flu shot until 10/2006.  Medical records reveal patient w/colic; neonatal SDH; left lazy eye; otitis media; GERD.  States patient has multiple food allergies, multiple bouts of OM, PE tubes & Fifths disease.  Autism not mentioned in their chart until 2/15/07.  11/26/07 Reviewed vax record from prior pediatrics office which indicates vaccinations for 1/3/2003 of DTaP, Hib, HBV & PCV given elsewhere by unknown clinic.  No additional medical records available. 1/15/08 Reviewed medical records provided by parent.  Office note of 7/14/2006 states dx of pervasive developmental delay.
Heart palpitations began about five days after vaccine.  Started just a few times a day, but increased to several times per hour over the course of the last two weeks.  I have just visited my GP to investigate. Lab tests and heart monitor have been ordered.
Swelling noted 8-13-12 by mother, redness, swelling, hot to touch. Child c/o tenderness, yesterday and today. Today it is noted, 10 x 14 cm redness on (L) deltoid, warm to touch, tender. Mom reports it has gotten worse since yesterday.
Upper arm swollen and red about two inches below injection site, and warm to the touch. Did not clear up for a full week.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 4-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0172), at the age of 40, via an unspecified route of administration, in left arm, on Apr 23, 2021, at 04:00 pm, single dose, for COVID-19 immunization. Patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EW0153), via an unspecified route of administration, in left arm, on Apr 2, 2021, at 04:00 pm, single dose, for COVID-19 immunization. The patient's medical history not reported. Concomitant medications included Tylenol (paracetamol), cefixime, Flexeril and Toradol (ketorolac tromethamine) for an unspecified indication, start and stop date not reported. Patient did not have COVID-19 prior vaccination. Patient has not undergone a COVID-19 test post vaccination. Patient had not received any other vaccine in four weeks. On Apr 25, 2021, at 12:00 pm, patient experienced hives (on neck, chest, stomach, back and upper arms); bad taste in mouth and fatigue. Patient received treatment with hydrocortisone cream. The outcome of events recovered with lasting effects on unspecified date in 2021. No follow-up attempts possible. No further information expected.
Sore arm for 8 days, headache and sore throat for 6 days, intermittent fever for 6 days, sometimes in excess of 100 degrees.   Temperature for last 3 days has been normal in the mornings but patient runs low grade fever on a daily basis beginning early, to mid afternoon.
dose administered with gray particulates from vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (dose administered with gray particulates from vial) in a not specif patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Mar-2021, the patient experienced PRODUCT QUALITY ISSUE (dose administered with gray particulates from vial). On 09-Mar-2021, PRODUCT QUALITY ISSUE (dose administered with gray particulates from vial) had resolved. Not Provided      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 concomitant medications or treatment details reported.
Patient received HPV 9 in R deltoid.  Remained on the exam table in a laying position for 5 minutes and in room for 10 minutes post vaccination.  Patient felt faint and mother assisted patient to table. Patient loss of consciousness for 1 second approximatly.  BP taken, juice, and crackers given.  Patient remained for observation and provider examined prior to release.  Chart alert placed.
On the 6th day (2/3/21) after receiving the vaccine my arm started to severely itch constantly at the location of the injection  and it continues into the 7th day (today) with no relief.  I haven't scratched it knowingly but may have during the night. There is no pain or other reaction.
Patient fainted about 5 minutes after the administration of the flu shot. He was taken to the hospital where he was treated. The next day (about 24 hrs later) he broke out in hives and was given a MEDROL dose pak.
Topical skin reaction, red spots that look similar to bruising or purpura. Not itching. Usually shows on chest and arms. The reaction seemed worsen after each dose. Hematologist said all lab work was normal and dermatologist said it looked like purpura.
After giving 1st vaccine, she felt dizzy when laying down; (She fainted) Gave the other 2 vaccines after waiting 5-10 minutes, she did well after being pale and thready pulse, We monitored her for 30 minutes in the office, History ofv fainting with blood draws and shots in the past   .I did not suspect this was an adverse reaction to the vaccine.
Constant lower extremities related pain unable to repair from day to day. Missing a ton of work.  I am currently awaiting scheduleing for nerve compression surgery on both arms with possible transposition. Numbness in both arms.
patient admitted 7/31/21 for covid 19 pneumonia/acute respiratory failure. Resulted positive for COVID 7/29/21.  Patient received covid vaccine in March.  Patient was exposed to his brother who was positive for  COVID 19.  Patient was intubated on 8/19 and expired 8/31/21.
Fever, chills, body aches, headache  Rash  Discoloration of toes
patient received the adjuvant only of Arexvy; patient received the adjuvant only of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number T3N4M, expiry date 05-MAR-2025) for prophylaxis.   On 13-NOV-2023, the patient received Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: patient received the adjuvant only of Arexvy) and inappropriate preparation of medication (Verbatim: patient received the adjuvant only of Arexvy). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 13-NOV-2023 The pharmacist reported the patient received only adjuvant of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sudden, extreme dizziness. It lasted from 6:30 pm through early morning hours, the next day. Minimal nausea.
20 - 25 Mins after shot, Left side of face from ear down to jaw and chin started to go numb and tingly. tingling continued down on left side of neck from ear to adams apple. Felt consistent with novocaine wearing off and my ear/jaw was numb. Went to ER @ the Hospital, I had an EKG done and they checked physically for stroke. I was in Hospital for approx. 1.25 hours and the feeling started to go away.
headache, site soreness, head cold.  Since receiving vaccines, I've had more than normal congestion, and more than normal tiredness which have both persisted since April 2021.
Rash at injection site; Swelling at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        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 Concomitant products were reported. No Treatment information was reported.
Wihin 2 hrs developed deep chronic cough, SOB, sore throat, vomiting. Later eyes (whites became pink) and drainage. HA.
Shoulder stiffness or a feeling of swelling.     Painful range of motion.     Sharp or pinching pain with overhead shoulder motions.  Symptoms ongoing. Bursitis likely due to high point of injection on the arm.
Headache, SkinRash, ErythemaMultiform, NauseaVomiting, weakness, brain fog, jerking/shaking Narrative:
PATIENT EXPERIENCES REDNESS AROUND INJECTION SITE. REDNESS SPREAD BIGGER AND WARM TO TOUCH. PATIENT SHOWS NO SIGNS OF PAIN OR FEVER.
This spontaneous report received from a consumer concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, sulfa allergy, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced swollen lymph nodes at injection arm. On 02-APR-2021, the subject experienced tender lymph nodes at injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen lymph nodes at injection arm, and tender lymph nodes at injection arm. This report was non-serious.
My arm hurts. My arm is hot. My arm is not red so I do not suspect infection. No fever. My arm is hard and swollen.
Td vaccine 7/10/03. Next day 7/11/03 fever to 104 degrees, not relieved by Tylenol/Advil. Family took to ER. Had spinal tap performed. 7/15-7/16 less fever, but rash on legs. Overall, we think this was viral infection, but are sending report, since it occurred within 24 hours of vaccination.
Area of erythema 11x9cm developed over left thigh vaccination site; +associated fever and fussiness. Symptoms developed 48 hours after vaccination.
Information has been received from a pharmacist concerning a pt who was vaccinated last week with Pneumococcal 23v polysaccharide vaccine (lot 650457/0973P). Subsequently, the pt developed arm redness. Unspecified medical attention was sought. No further information is available.
Subsequent to receiving one dose of varicella virus vaccine live on 1/25/99, the pt discovered she was pregnant. A serum test at the time of vaccination was negative. The pt gave birth to a healthy, normal female.
tested positive on the 11th; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received his first COVID shot last 03Feb2021. He tested negative on 10Feb2021 and tested positive on 11Feb2021 and 12Feb2021 for rapid test and lab test. On 14Feb2021, he had monoclonal antibody infusion. The patient wanted to know if he still needed to go to his second vaccine shot appointment that was scheduled on 24Feb2021. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Caller states he has a history of eczema and this itching is interfering with his daily life; primary series vaccine a year ago and has been itching more than a year.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "Caller states he has a history of eczema and this itching is interfering with his daily life"; PRURITUS (non-serious), outcome "unknown", described as "primary series vaccine a year ago and has been itching more than a year.". Additional information: Pfizer-BioNTech COVID-19 Vaccine reported as Gray cap. Caller is asking if there is any Information about how to stop his itching. Caller states he has a history of eczema and this itching is interfering with his daily life. He states he received his primary series vaccine a year ago and has been itching more than a year. Localized to "my arms and under my calves."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.