chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose volume, route of administration, lot number, expiry date were not reported). On 10-MAR-2015 the patient experienced swelling and itching on her hands. On 11-MAR-2015, when she woke up, she was experiencing unbearable itching on her feet. The patient did not seek a medical attention. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected because the patient's and physician's contact details were not provided.
1027 patient asked for assistance and promptly lost consciousness, Patient assisted to the ground by LVN and LVN. Interventions and vitals initiated. Patient lost consciousness for about 15 seconds. Patient sternal rubbed. Patient slowly started to blink and start to correctly answer questions. Patient legs elevated on chair. BP 119/71, Pulse 74, SaO2 98%, Resp 22, Temp 98.2. Patient slowly lifted and sat upright on the ground. Tolerated water. 1035 vitals, BP 117/62, Pulse 69, SaO2 98%, Temp 97.2, Respirations 18. Patient tolerated standing and moved to the back of observation to sit down on the ground once again. 1038 Patient stated she felt dizzy, so she was laid down again, vitals WNL, alert and oriented. 1045, BP 119/68, Pulse 64, SaO2 99%, Resp 20. Patient is sitting and alert. Patient tolerating sitting on chair upright. Partner at her side. 1100 patient vitals BP 124/74, Pulse 69, SaO2 98%, Temp 97.2, Resp 20. Patient educated on getting some rest and water and avoid any strenuous activity. If symptoms return or worsen to seek medical attention. Patient left site without further incident.
This spontaneous report as received from a nurse refers to a 13 month old male patient. On an unknown date the patient was vaccinated with ROTATEQ dose 1 (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the 13 month old patient received a second dose of ROTATEQ orally. No adverse events were reported. The outcome event was unknown. The action taken with the ROTATEQ was unknown. The relatedness of the events to the therapy with ROTATEQ was unknown. No product quality issue was reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment/ Return of milder symptoms, body aches, mild fever, and nasal congestion.; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 05Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Long QT Syndrome" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 02Jan2006. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15Jul2022, outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset 15Jul2022, outcome "not recovered", described as "COVID 19 Treatment/ Return of milder symptoms, body aches, mild fever, and nasal congestion.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (15Jul2022) positive, notes: Retested via rapid antigen test prior to an event on 15Jul and reverted to positive; SARS-CoV-2 test: (08Jul2022) Negative, notes: Negative COVID-19 tests; (09Jul2022) Negative, notes: Negative COVID-19 tests; (10Jul2022) Negative, notes: Negative COVID-19 tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with Paxlovid started on 02Jul2022 and ended on 06Jul2022.  Clinical course: No known allergies.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Drug ineffective and COVID-19 cannot be ruled out.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age. On an unspecified dates, doses of improperly stored PROQUAD (Merck) (dose/frequency and lot # were unknown) might had been administered to the patients; this was unable to be confirmed with nurse. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Myalgia, Arthralgia, Fever & Diarrhea Narrative:  Diarrhea, body aches, fever and fatigue.
ever since 2021, I've been getting these random bouts of allergic reactions to random things. By late November it was flaring up again to the point I had to see my allergist in January because it got progressively worse. I was responding to spinach, preserved foods, alcohol, N95 masks, red dyes. I was also starting to react to cold things, Alpha Pinene; elastic in my socks. adhesives started to bother me, like in band-aids, tomatoes. Soy has become an issue since 2021 that wasn't an issue before but it started flaring up again. Other things as well but those are the major ones. I was getting itchy all over like things were crawling all over me. Sometimes I would get hives but before the hives it would be like saucer sized disc shapes on my arms, but it would develop into hives. Abdominal and "normal" migraines are a part of my allergic reactions, and I would also start flushing randomly on my chest, arms, and face. But it was like I was suddenly allergic to random things that I wasn't having issues with before. I spoke with my neurologist about the migraines and she directed me to my allergist because it sounded like mass cell issues. I saw my allergist and she upped my ketotocine. I also had been rationing my previous dose because I was running out. I cannot currently afford the larger dose but once I started taking my regular dose again it started getting better. About two and a half to three months after my previous COVID-19 doses, every single one of them, I was suddenly reacting to things
Adverse effect of pertussis vaccine, including combinations with a pertussis component, initial encounter, Adverse effect of other vaccines and biological substances, initial encounter on 2020-06-14.
Pt. states that after receiving the 1st dose of Pneumo Prevnar 13 11/22/2021, started experiencing symptoms 11/26/2021 of rash at the injection site and warm to the touch. Pharmacist communications suggested reporting. No noted Primary visit/communications. Still experiencing symptoms.
8 1/2 hours after second dose, Fever 102.8, body aches, swollen lymph nodes in neck and arm pit, headache, chills, sweating, sore arm at injection site, swollen at injection site, itchy and swollen.   all but the swollen arm and lymph nodes went away after 24 hours. Arm got better after 1 week. Lymph nodes were better after  6 days.  13 days later I now have hearing lose in my left ear.
SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 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 subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Discomfort in neck and head; Pain goes up to her neck and beyond her ear / neck hurts; can't sleep; can't eat; she's stiff and very uncomfortable; pain in the left arm / first it was just achy; very uncomfortable; discomfort head; Is tired of hurting; joints hurt too; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Discomfort in neck and head), NECK PAIN (Pain goes up to her neck and beyond her ear / neck hurts), INSOMNIA (can't sleep), DECREASED APPETITE (can't eat) and MUSCULOSKELETAL STIFFNESS (she's stiff and very uncomfortable) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and LOSARTAN for Blood pressure high.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Discomfort in neck and head), NECK PAIN (Pain goes up to her neck and beyond her ear / neck hurts), INSOMNIA (can't sleep), DECREASED APPETITE (can't eat), MUSCULOSKELETAL STIFFNESS (she's stiff and very uncomfortable), PAIN IN EXTREMITY (pain in the left arm / first it was just achy), DISCOMFORT (very uncomfortable), HEAD DISCOMFORT (discomfort head), FATIGUE (Is tired of hurting) and ARTHRALGIA (joints hurt too). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Discomfort in neck and head), NECK PAIN (Pain goes up to her neck and beyond her ear / neck hurts), INSOMNIA (can't sleep), DECREASED APPETITE (can't eat), MUSCULOSKELETAL STIFFNESS (she's stiff and very uncomfortable), PAIN IN EXTREMITY (pain in the left arm / first it was just achy), DISCOMFORT (very uncomfortable), HEAD DISCOMFORT (discomfort head), FATIGUE (Is tired of hurting) and ARTHRALGIA (joints hurt too) outcome was unknown.            Treatment included hot compresses and baths   This case was linked to MOD-2021-254177 (Patient Link).
a 6 years old patient received FLUBLOK vaccine/No AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] pre-filled syringe (lot: UJ446AA, expiry date: 18-Mar-2021), via intramuscular route in left deltoid on 30-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were unknown.  It was case of an actual medication error due to the inappropriate age at vaccine administration (latency same day).  It was reported that that a 6 year old received Flublok Quadrivalent which was not intended and the reporter wants to know if correct Fluzone Quadrivalent can still be given and if so then how long if at all time to wait before.  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.
The pt developed light/sound sensitivity, motor/vestibular/proprioceptive difficulties, lost speech, cognitive dysfunction, GI disturbances. Also it is stated that the pt received 237.5 mcg of Hg from 02/08/1998 to 03/15/1999 which exceeds federal safety limits. The pt is being tested for mercury (DMSA challenge). Profound developmental delay.
arm swollen double in size with extreme redness and pain and very hot to touch, headache, dizziness, excessive fatigue, headache, bad neck pain, chills. 103.9 temp,
Surrounding immunization site with induration, edema, erythema over (L) deltoid and separate area over (L) bicep lower. No evidence of cellulitis, non tender. Pt c/o muscle aches, chills, cough starting 2 days after shot.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BODY TEMPERATURE INCREASED (feeling as sick as a dog with temperature) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), BODY TEMPERATURE INCREASED (feeling as sick as a dog with temperature) and VOMITING (vomiting). At the time of the report, DIARRHOEA (Diarrhea), BODY TEMPERATURE INCREASED (feeling as sick as a dog with temperature) and VOMITING (vomiting) outcome was unknown.            no concomitant  medication was listed.
Reporting breakthrough case: I started having post nasal drip symptoms and a raspy voice. I took Zyrtec and it went away because I thought it was allergies. I tested myself and was positive. I am quarantined for 10 days. I do still post nasal drip and a raspy voice. I was ordered to continue taking medications as needed.
Bad Dizziness the next morning after the shot.  Each day it is getting less but has not gone away.  I have not gone to the doctor.   I am concerned because I know this shot was the smaller dose of the two and when I get the next shot will the Dizziness be more severe?
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-OCT-2011, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster ophthalmus. On or about 09-NOV-2011, the patient sought subsequent treatment from a physician for a vesicular outbreak, which was diagnosed as herpes zoster keratitis. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, herpes zoster ophthalmus and herpes zoster keratitis were determined to be medically significant. Additional information has been requested.
2/20/2021- Non pruritic rash to trunk, arms, chest, hands and thighs. (Unilateral)  Went to Emergency Dept and was treated with Benadryl, Solumedrol and Pepcid.  3/4/2021- Started on Prednisone 3/5/2021- Shortness of breath, stridor, edema to lips and periorbital. Treated in the ED with Benadryl, Solumedrol and Pepcid.  5/1/2021- Presented to the ED with cough, facial edema and shortness of breath. Treated with Benadryl, Solumedrol and Pepcid.  5/7/2021- Allergist increased Citirizine dosage to 40mg and started Pepcid daily as maintenance dosing. 5/18/2021- Presented to ED with dysphagia, shortness of breath and facial edema. Treated with Epinephrine, Benadryl, solumedrol and Pepcid. 5/20/2021- Presented to ED with facial/periorbital edema. Treated with solumedrol, pepcid and benadryl.  5/21/2021- Allergist prescribed Singulair (is working on insurance clearance for Xolair also)
STOMACH NOT FEELING GOOD; GAS INSIDE THE STOMACH; NOT FELT GOOD AFTER VACCINATION; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced stomach not feeling good, gas inside the stomach, not felt good after vaccination, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach not feeling good, not felt good after vaccination, nausea and gas inside the stomach was not reported. This report was non-serious.
Significant symptoms of influenza (only moderate in severity, but more severe than expected),  plus severe local injection site pain.
32yo female reported dizziness at the vaccination table immediately after receiving Janssen vaccine at 10:40. BP 90/70 with pallor Client given water and put her head down Client reported feeling better and color returned No EMS called Ambulatory to observation area with family and nurse
Patient developed pain in arms and body with tremors. Had appointment at 10:15 yesterday morning with MENVEO, GARDASIL and BEXSERO, afterward he had bilateral upper arm pain which progressed outward down arm and onto back, then to total body by midnight last evening, earlier in evening he attended pool party, ate a hamburger and fries, saw a movie, then came home and collapsed from pain, mom assisted him to the couch where she describes muscle tremors and he had pain everywhere escalating to a 9/10, she reports weakness and he reports intermittent neuropathic sensation similar to "when your arm falls asleep", she was able to assist him to get to the restroom around 01:30-so he was able to ambulate with assistance.
Extensive  Meningitis  Sepsis Infected CSF   Please contact Hospital for completely information
This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 12th November 2018, the patient received SHINGRIX. On 14th November 2018, the patient received SHINGRIX. On 12th November 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 14th November 2018, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the fever and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 12th November 2018, the patient only received the liquid component of the SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient came back to the physician's office on 14th November 2018 where he received the full dose of the SHINGRIX. Less than a day after receiving SHINGRIX, the patient experienced fever and shivering starting at approximately 7 or 8 pm and lasted for 12 hours after receiving the vaccine. The reporter consented to follow up. The reporter gave permission to contact his physician.
passed some blood when he went to the bathroom; fever of 100 degrees; This is a spontaneous report from a contactable consumer, the patient.  A male patient of an unknown age (reported as 73 with no units provided) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 12Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On 13Feb2021, the patient passed some blood when he went to the bathroom and had a fever of 100 degrees Fahrenheit. The clinical outcomes of the passed some blood when he went to the bathroom and fever were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
a 24 months old girl was given a expired 0.5 ml dose of Daptacel/No AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 24 months old female patient who was given an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C52818A (exp date: 05 Oct 2019) via intramuscular route in the right vastus lateralis on 09-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) via intramuscular route in the right vastus lateralis.  It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.