chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doctor reports an 8 year old patient is behind on his Td vaccine schedule and she may use Boostrix to catch him up; Circumstance or information capable of leading to medication error; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient did not receive Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Doctor reports an 8 year old patient is behind on his Td vaccine schedule and she may use Boostrix to catch him up) and circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error).  The outcome of the inappropriate age at vaccine administration and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2023 The reporter reported that an 8 years old patient was behind on his Td vaccine schedule. The reporter stated that she may use Boostrix vaccine to catch him, which led to age at vaccine administration and Circumstance or information capable of leading to medication error. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as in past six months), the patient was vaccinated with ZOSTAVAX (unknown route and dose) lot # L028280 and expiry date of 28-OCT-2015 in left arm. Concomitant medications were not reported. The patient had come to pharmacy to complain of injection site adverse events post vaccination with ZOSTAVAX. The patient developed injection site reaction of left arm that was circumference of egg size, raised, warm, painful on an unknown date in 2015. The outcome of the events was unknown. Causality assessment was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
as per patient she was unable to lift both the arms for 3 days, and she had bruise in right arm for 3 weeks and her left arm is fine now but not the right arm. she is starting physical therapy from 11/22/2019 as advised by her doctor
Symptoms: Symptoms: 1. Dizziness, 2. Nausea Vomiting, 3. Flushing Suspect Drug # 1 Dosing: Flu vaccine yearly.
Received phone call on 05/17/19 from patients wife explaining that they day after the vaccination the patient reported significant joint pain. She also stated that as of 05/16/09 the patient had been experiencing a "welt like rash" on his face and that his hands had been swelling. I advised her to take her husband to see a provider and that given that it had been three weeks since vaccination it may be difficult to know if this current reaction is due to a vaccine reaction.
Sore/ Hurt more than any other previous vaccination / previous flu shots; This case was reported by a pharmacist via sales rep and described the occurrence of pain in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The previous flu shots the patient had received were sore and they hurt. This case has been linked with US2020AMR225312 reported for same patient by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225312:Shingrix + Flu shot, same patient
within a few hours of 1st shot, started feeling "pins & needles" throughout my entire body.  Symptoms still continue even after the 2nd shot; This is a spontaneous report from a contactable consumer (Patient).  A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 20Mar2021 at 10:15 (at the age of 58-years-old) as dose 1, single dose, and again received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number:  EWO158), via an unspecified route of administration, administered in left arm on 10Apr2021 as dose 2, single for COVID-19 immunisation in Health Clinic. Medical history included high blood pressure, cholestrol, pvc's. The patient has no known allergies. The patient has not been diagnosed with covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), metoprolol, amlodipine, atorvastatin. On 20Mar2021 at 12:00 (within a few hours of 1st shot), patient started feeling pins and needles throughout her entire body. Symptoms still continue even after the 2nd shot. The events resulted in Doctor or other healthcare professional office/clinic visit. The reporter considered the event as Serious. Location of injection information is available for all vaccines received on the same date. No treatment was received for the adverse events. The patient has not been tested for Covid since the vaccination. The outcome of the event was not recovered.  Follow up needed, further information has been requested.
Large area of minor swelling redness and warmth over 2 days (ant thigh) Tx with MOTRIN and ice.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergy: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2023) Positive, notes: Had positive test Friday and Monday; (29May2023) Positive, notes: Had positive test Friday and Monday. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 21May2023 to 25May2023.  Clinical course: Patient received vaccine and no other medication in 2 weeks. Finished paxlovid on Thursday. Felt better Friday-Sunday, then started with aches and pain and severe nasal congestion on Monday. Had positive test Friday and Monday.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
became injured; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced became injured (injury), while he/she received vaccine INFLUENZA VACCINE.  It was unknown if the patient had no medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious became injured (injury) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if patients physician provided consent to be contacted It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
2 others and they had the same pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administered in arm left (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "2 others and they had the same pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He was just congested for 24 hours; Tested positive for COVID post vaccination; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 23-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration in deltoid left on 20Jan2021 at 09:20 am as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. No family history. On 01Feb2021 after 10 days the patient was tested positive for covid post vaccination, and he was just congested for 24 hours on an unspecified date. She was tested positive for COVID post vaccination. He wants to know if he can get the second dose of the vaccine. Patient was barely symptomatic, he was just congested for 24 hours. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 01Feb2021. No prior vaccinations within 4 weeks. Patient did not any AE(s) require a visit to Emergency Room and Physician Office. No treatment received. The outcome of the events was unknown.
A non-serious spontaneous report of three patients received expired FLUMIST was received from a health professional concerning a seven-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The product expired in 29-Nov-2010. On 14-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse events were reported for the this patient.
HORRIBLE REACTIONS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight was 100 pounds, and height was 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced horrible reactions, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of horrible reactions was not reported. This report was non-serious.
3/12/2021 Vaccination. 3/20/2021 I went to work. About 2-3 hours later, I became weak and unsteady on feet. I started to feel sick to stomach, nauseated, couldn't hold my head up, hot and sweaty. I felt almost like 'toxic shock'. I went to bathroom to cool off and by time came back the EMT's were there. They transferred me to urgent care for precautionary care. Monitored vitals; discharged home.
The shot was on the 13th and my reaction started on the 16th. My left arm at the site of the shot began to hurt in the same way it did when I got the shot. Shortly after I noticed that a rash broke out on my chest and neck which then spread to my upper abdomen, upper back and inner forearms.
Patient is a 53-year-old female who began having right upper quadrant pain earlier in the day on Thursday.  Got progressively worse.  She had associated nausea vomiting.  She has known gallbladder disease.  Couple years ago before COVID she had an intact with similar had ultrasound showing sludge in gallstones.  She presented emergency room last night with a white count of 11000.  Ultrasound showed gallstones with a stone lodged in the neck of the gallbladder.  Liver function tests were within normal limits.  She had ongoing symptoms and pain which was only controlled with morphine.  I was asked admitted for management of symptomatic cholelithiasis. DISCHARGE SUMMARY HAS NOT BEEN UPLOADED AT THIS TIME.
11/2/23 4:30-530 PM: light headedness, fatigue, headache, nausea, body aches, 5:30- 6:30PM: shortness of breath, chest pain, headache, body aches, bradycardia (32-68 bpm, varying), oxygen saturation 90-93%. ear fullness, fatigue 7:00 PM Blurred vision, headache, shortness of breath, chest pain, body aches, ear fullness, fatigue 8:00 PM after sleeping, blurred vision, headache, hives present on arms and itching all over body, ear fullness, fatigue. 9:00 PM headache, hives diminishing, fatigue, insomnia did not sleep until 3:00 AM 11/3/23 7:30 AM headache, nausea, body aches, and current at 11:19 AM None, managed with albuterol inhaler 2 puffs PRN, sleeping when possible, sitting up, increased fluids, alternated Tylenol and ibuprofen every 4-6 hours and still continuing current interventions.
Systemic: nose bleeds-Mild, Additional Details: patient called and reported having nose bleeds which is not common for patient. Had patient call provider and provider stated it was not a huge concern no bleeding in stools. Told patient to call us and keep us updated.
chills; not feeling well; vomiting/throwing up; dry heaves; headache; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 15:00 (Lot number: EN6204) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY taken for diabetes mellitus; METFORMIN taken for diabetes mellitus. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; VOMITING (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "vomiting/throwing up "; RETCHING (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "dry heaves"; HEADACHE (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "muscle pain"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  No follow-up attempts are possible. No further information is expected.
The patient's arm is red at the administration site and dark red and purple around the site. It is get progressively better every day patient's wife stated.
This child had an ER visit 09/02/00, complained of large red blotchy rash, joint pain, knee and ankle swelling. Bilateral otitis media, and a sore throat was noted. Henoch- Schonlein Purpura.
Redness on her arm; Rash is itching; Rash is really warm; A rash on her arm the rash was not on her skin it was under it and pink; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Redness on her arm), RASH PRURITIC (Rash is itching), SKIN WARM (Rash is really warm) and RASH (A rash on her arm the rash was not on her skin it was under it and pink) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fracture (fracture in her back).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced ERYTHEMA (Redness on her arm), RASH PRURITIC (Rash is itching), SKIN WARM (Rash is really warm) and RASH (A rash on her arm the rash was not on her skin it was under it and pink). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Redness on her arm), RASH PRURITIC (Rash is itching), SKIN WARM (Rash is really warm) and RASH (A rash on her arm the rash was not on her skin it was under it and pink) outcome was unknown. Not Provided          Concomitant medication included muscle relaxer and pain medication to get over back fracture. Patient used ice pack to treat her symptoms. Patient felt ill hence she delayed her 2nd shot.   This case was linked to MOD-2021-075125 (E2B Linked Report). This case was linked to MOD-2021-075125 (Patient Link).; Sender's Comments:  MOD-2021-075125:1st dose of vaccine
The COVID Bivalent vaccine was given to him under the age of 12 years.  No adverse effects were noticed.
HARD, RED, HOT, AREA GROWING IN SIZE OVER 3 DAYS.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011117, expiry date: 17-DEC-2017). No adverse effects were reported. Excursion information: Time: 30 minutes, Temperature: 9C and Time: 30 minutes, Temperature: 11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 10/21/98; on 10/22/98 pt exp LA erythema(4x5cm) w/ induration.
Information has been received from a licensed practical nurse concerning a 23 year old female with no pertinent medical history reported and no known drug allergies who on 30-APR-2009 was vaccinated with first dose of GARDASIL (route not reported, lot number 661954/1131X). There was no concomitant medication. One day after vaccination, on 01-MAY-2009, the patient experienced groin swelling and flu-like symptoms. The patient recovered on an unspecified date. The patient sought medical attention by calling the office. Additional information has been requested.
Pt received any adult Hep B as third dose instead of Child/adolescent dose. No adverse reaction reported.
Heart was racing, blood pressure spiked, lasted about 3 or more hours. Fatigue
pt recvd vax 6OCT95 & began w/h/a w/in 1-2 hrs had hard shaking chills, stomach cramps (severe) t105, diarrhea, trouble breathing;did not seek medical care @ time;only reported 11OCT95 to med dept to see pvt MD;feeling better now-weak;virus
Information has been received from a healthcare worker concerning a female patient (age unspecified) who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (date, dose and frequency unknown) in another country as a child had an unspecified allergic reaction. The caller did not have any other information on the administration of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient recovered from the unspecified allergic reaction on an unknown date. It was not reported if the patient sought medical attention. There was no product complaint. No further information is available.
This is a spontaneous report from a contactable consumer. This 78-year-old female consumer received a dose of PREVNAR12 on 21 JAN 2014 at 11:45 single dose in the right arm. Relevant medical history included hip replacement surgery done on an unknown date. Relevant concomitant medication was unknown. The consumer reported that on 21 JAN 2014 at 15:00, she had an allergic reaction to it. Joints of her left hand swelled up and inflamed, her knee welled up, her ankle and calf sw3elled up, she couldn't mover her legs and feet, she was in severe pain, she had chills, her blood pressure went sky high, she couldn't move her fingers, couldn't move her joints, she had pain in the wrist and she had red streaks at the site of injection. The consumer also reported that on an unknown date several years ago she had an allergic reaction with unspecified tuberculosis vaccine. Relevant laboratory data included blood work and x-ray, both done on 22 JAN 2014, the results were unknown at the time of reporting. Therapeutic measures taken in response to the reported events were unknown. The consumer had not recovered from the event "had red streaks at the site of injection" while she had recovered from all other events on an unknown date in JAN 2014.
Varicella Injection site was slightly swollen one day after injection per patient report.  Site evaluated by RN 48 hours after injection and had 60 mm red hive with some swelling of the upper arm and some tenderness noted.
COVID-19; Suspected COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 09May2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  It was reported that Rebound of COVID-19 symptoms. High level on antigen test after having been tested negative after treatment. Chest congestion came back after being cured by Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough case admission after 4 vaccines Moderna 12/30/20 Lot# 025L20A;  Moderna 1/27/21 Lot#004M20A;  Moderna 10/26/21 Lot# 041C21A;  Moderna 4/11/22 Lot# 027L21A