chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/19/16 client in with boyfriend for travel IZs for 3 months. Advised IZs per CDC. Immunized as charted. Recommended Japanese encephalitis and possibly rabies vaccines, client will check with insurance to see if they are covered before getting these. Client was given written information on mosquito precautions, food and water precautions, road safety, sun safety, avoiding animals, finding medical care abroad, travel medical insurance providers, and a medical packing list. A country profile with basic preventative measures was printed for client. Assessed for malaria risk -- present. Recommended doxycycline or MALARONE and explained how to take it based on risk areas visited. Highlighted water disinfection, medications abroad, finding medical care, and medical evacuations during visit. Client denies having any questions at this time. 09/22/16 client left a voicemail stating he took two pills back to back. LVM for client instructing him to continue taking the pills at the right intervals. 09/26/16 client left a voicemail over the weekend stating he had hives all over his body and would probably be ok with the three typhoid pills for partial protection. LVM to client asking him about other symptoms, when they started, if he took anything, if he took the last typhoid pill. 09/28/16 Called client again to check in. Client states he did not take the fourth pill. Explained I would ask advise from the manufacturers regarding 3 year protection from the first three pills even if the first two were taken back to back. Per client, he took pill #1 on 9/20, #2 on 9/21, #3 on 9/23. Client states he developed a rash on Friday evening in his armpit. He states the next morning the rash extended to his "back, butt, chest, neck, face." States he took 50mg of BENADRYL then went to the ER. Per client, he was prescribed steroids but has not taken them. He last took a BENADRYL on 9/27/16 at night. Client described the rash as very itchy "splotchy little welts" that came together to form a big welt. He also described it as "reactive to touch" stating he had a hair tie around his wrist and developed part of the rash where the hair tie had touched his skin. Client states today that rash has gone away and it's not bothering him anymore. Client denies any other symptoms (airway, cardiovascular).
SWELLING ON HIS KNEES; JOINT PAIN; HORRIBLE CHILLS; FEVER OF 105.9 F; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 135 pounds, and height was 173 centimeters. The patient's past medical history included marijuana use, and concurrent conditions included penicillin allergy, alcohol use, smoker, lactose intolerance, attention deficit hyperactivity disorder, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for ADHD, and anxiety, and hopantenate calcium for ADHD, and anxiety. On APR-2021, treatment medications included: ibuprofen.  On 06-APR-2021, the subject experienced swelling on his knees, joint pain, horrible chills, fever of 105.9 f. Laboratory data included: Body temperature (NR: not provided) 105.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible chills on 10-APR-2021, and fever of 105.9 f on 09-APR-2021, and was recovering from joint pain, and swelling on his knees. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Information has been received from a nurse practitioner concerning an 8-year-old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed chickenpox with lesions all over after vaccination. It is unspecified if medical attention was sought. No outcome was reported. No product quality complaint was issued. Additional information has been requested.
Pt had local reaction to DTaP right deltoid - red, hot to touch, swollen 3.5" x 4" - now tender.
Pt recvd 1st dose  Hep B vax on 16DEC91 & 2 days later pt exp nausea, vomiting, h/a, myalgia, diarrhea & became dehydrated; presented to ER tx antiemetics & analgesics; pt not hospitalized; felt exp was related to vax; 27DEC91 pt recovered;
Hives at first and constant itching since; Hives at first and constant itching since; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: EL3248) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Type 2" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC. Past drug history included: Metformin, reaction(s): "known allergies: Metformin". Vaccination history included: BNT162b2 (Dose number 1, vaccine location: Right arm, lot number: EJ7686), administration date: 25Feb2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), PRURITUS (non-serious) all with onset 22Mar2021, outcome "not recovered" and all described as "Hives at first and constant itching since". The events "hives at first and constant itching since" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, pruritus.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. No, other vaccine in four weeks.  No covid prior to vaccination. Tested positive post vaccination.Other medications in two weeks was Ozempic. Treatment received included Zolar and Dupixant. Covid test type post vaccination was Nasal Swab on 24Jan2022 which resulted negative.
Covid like symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED COVID-19 (Covid like symptoms) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced SUSPECTED COVID-19 (Covid like symptoms). At the time of the report, SUSPECTED COVID-19 (Covid like symptoms) 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.   This case was linked to MOD-2021-030810 (Patient Link).
Rash on Back and on sides wrapping around to the front of chest, primarily on the back. Associated with urticaria.  The patient developed headache, lack of taste, fatigue as well as the aforementioned rash on 1/14/2021(6 days after receiving first dose of covid vaccine.  A rapid covid test was positive on 1/14/2021 also.  The patient was prescribed claritin, methylprednisolone for the rash after seeing his family physician virtually and the family physician recommended he contact where he was vaccinated to report these symptoms.  I have reached out to the patient for additional information and he has declined, so I do not have any access to details on his positive covid test or records from that virtual encounter.
Patient's guardian filled out questionnaire with wrong date of birth, and the pediatric covid vaccine was given for a 13 year old patient instead of the adult dose.  There were no side effects.
LOSS OF HAIR FROM EYEBROWS AND EYELASHES Narrative: ALOPECIA .
Myalgia, Fever,  LETHARGY, SITE DISCOMFORT AND ITCHING  BOTH DOSES
Sore arm; Site of injection was warm to touch; Red blotches at the site of injection and front of the shoulder; Shoulder was also sore; injection site red blotch; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AS54, expiry date 15th May 2022) for prophylaxis.   On 24th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 25th May 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema. On an unknown date, the outcome of the pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced sore arm going all the way to the top of the shoulder, the site of injection was warm to touch, and red blotches appeared at the site of injection and front of the shoulder.  The front of the shoulder was also sore.  The side effects are subsiding, but it was still present as per pharmacist last conversation with patient. No other details were provided. This case linked with US2020091747, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091747:same reporter
Patient received expired vaccine. 3/26 expiration and received on 3/30/22. No adverse effects.
No additional adverse effects reported; Expired vaccine given to patient; This spontaneous report has been received from a registered nurse concerning a  5 year-old patient of unknown gender.The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.         On 13-AUG-2020,  the patient was administered an expired but properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # S003864, expiration date 08-AUG-2020 for prophylaxis (dosage regimen was not provided). No additional adverse effects were reported and a temperature excursion did not occur..
I had swelling of my lymph node; it got the size of lemon. It was extremely painful; it was hot to touch and hard.  When I saw the doctor, he said to just watch it and it did go down after several days.
Facial paralysis right side of face; soreness behind right ear; watery eye; difficulty closing right eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF259U) and as dose 4 (booster), single (Lot number: FM7553) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergie: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: FACIAL PARALYSIS (non-serious) with onset 28May2022 at 02:00, outcome "not recovered", described as "Facial paralysis right side of face"; EYE DISORDER (non-serious) with onset 28May2022 at 02:00, outcome "not recovered", described as "difficulty closing right eye"; EAR PAIN (non-serious) with onset 28May2022 at 02:00, outcome "not recovered", described as "soreness behind right ear"; LACRIMATION INCREASED (non-serious) with onset 28May2022 at 02:00, outcome "not recovered", described as "watery eye". Therapeutic measures were not taken as a result of facial paralysis, ear pain, lacrimation increased, eye disorder.  Clinical course: Most recent dose details: product=COVID 19, Brand: Pfizer, Vaccine, lot Number=FM7553, Administration date=23May2022,Administration Time: 09:30 AM, Dose number=4,vaccine location=Right arm. Other vaccine same date details: lot number=FF259U,same date vaccine date=23May2022,Same date dose number=3,Facility type vaccine: Public Health Clinic/Military Administration facility. If other vaccine in four weeks: No. If covid prior vaccination: No. if covid tested post vaccination: No.  No follow up attempts are needed. No Further information is expected.
16 year old patient was administered with Flublok with no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old female patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1931, expiry date: 30-Jun-2020 via intramuscular route in the left arm on 13-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
High fever of 103.5-103.8 that lasted almost 3 days, included runny nose, congestion, and some wheezing.
@ 10PM 9OCT96 devel jerking of arms & legs & head w/similar type of minimal grunt;these lessened when pt nursed & nursed well;then fell asleep but had some similar movements;pt was fine the next morning;
Received influenza H1N1 vaccination this morning.  Rapid escalation of temperature to 104.6 degrees six hours later.  Given tylenol at home.  Seen in Urgent Care clinic adn temp still 103.2 degrees.  Had normal exam and was well appearing.  No further treatment given.
Employee rec'd Hepatitis B vax on 25MAR91; Approx 1hr p/receiving the vaccine she c/o severe h/a unrelieved by aspirin, APAP, "goody powders", or Advil; Employee also c/o nausea, but no emesis; sl tmep (99);
In the 6 years that I have had the Nexplanon birth control implant I have never had my period or any spotting. 3 weeks exactly from the first dose and I have a period. I can tell it?s the shed lining and not an injury from the tissue coming out.
1/5/00, temp 102, L/deltoid red, swollen, painful knot. 1/7/00, reported by mother, L/deltoid still tender w/small knot.
Pt c/o headache and low-grade fever last night, but reports headache resolved either the same night or early this am (pt wasn't sure). As of 10:30 a.m. this am, pt c/o slight nausea; dry, chapped lips; and low-grade fever. Reports taking Tylenol at 10:10 am right before reporting reaction. He never took his temp to verify low-grade fever.
Injection site nodule - slowly reduce in size within two weeks. The swelling hurt when touched for the first week. I still have a pea sized lump under my skin, but no other symptoms.
Patient was only 17 years old and 10 months, and moderna covid 19 vaccine was indicated for 18 years old .   Neither patient nor parents reported any  adverse events and no treatments were reported.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: described lip as tingling that felt like "spider walking across lip"
Pt c/o sudden onset of diarrhea severe headache and fever, chills. She was in bed most of the three days and she also developed jaundice. Symptoms resolved today (5/8/06).
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-395807 (Patient Link).
chills; fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever) and chills (Verbatim: chills). The outcome of the fever was resolved (duration 1 day) and the outcome of the chills was resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.     It was unknown if the company considered the fever and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Mar-2023 The patient just got the first vaccine, and he/she got a fever and chills for a day at the time of reporting,  after 3 to 6 months he/she had to get the second dose but she did not care about the fever, it was more painful to have it, a friend got it and it was very strong.
Post vax, pt had 2.5cm-3cm area of erythema at injection site on left deltoid.
received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster); received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster); received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single; Tested positive for Covid on 03Oct; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single. The following information was reported: COVID-19 (non-serious) with onset 03Oct2023, outcome "not recovered", described as "Tested positive for Covid on 03Oct"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "not recovered" and all described as "received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster)"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "not recovered", described as "received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single". The event "tested positive for covid on 03oct" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In october after my Booster Vaccine I had a sinus infection, I had the same symptoms like the chills sweats, and fever however it was not nearly as bad as the first two and I did not have any instances of passing out post booster vaccine. My hand tremors are still continuing as much as they were after my second vaccination. My primary care wanted me to get a test for Parkinson's however I have not scheduled that yet.
04/08/2022  My Right arm began hurting. The pain radiates from the vertebrae and numbness in the right arm.  It got to where I could not sleep and had numbness in my right index finger. I went to the hospital. The doctor told me it is because the nerve from the vertebrae is being pinched. He prescribed  Diclofenac Na 1 % and a muscle relaxer which I have not received yet. I am still having issues. I use ice and it helps with symptoms some.
Rash onset 11/6, initially attributed to AMOXICILLIN, but progressed to bruising rash diagnosed Henoch Schonlein Purpura, 11/7
After a few minutes receiving injection, associate c/o pounding HA, slight fatigue, and chills. Associate was had no fever - associate was highly anxious per her words and had a previous vertigo spell/panic attack with first dose. Associate was able to verbalize and maintain consciousness, had no vertigo spell and declined water.  Was able to leave under own power, steady gait,.
Chills; 104 degree fever; Body aches even in feet; Loss of appetite; Loss of taste; Metal taste; Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 04Jun2021 at 10:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 14May2021 at 10:00 as a single dose for COVID-19 immunisation. On 04Jun2021 at 21:00 the patient experienced chills, 104 degree fever, body aches even in feet, loss of appetite, loss of taste, metal taste and headache. On 04Jun2021, the patient underwent body temperature and the result was 104 degree fever. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events chills, 104 degree fever, body aches even in feet, loss of appetite, loss of taste, metal taste and headache were not recovered at the time of this report.   No follow-up attempts needed; No further information is expected.
Intense confusion  Panic attacks/ anxiety  Tight chest  Muscle and joint pain  Fever
All my symptoms are WORSE than when I had covid. My chills and aches are worse. Terrible headache. This CANNOT be safe for me to feel worse than I felt when I had COVID. my hands are going intermittently numb, as are other parts of my body. I am sore everywhere. This is wrong.