chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; LITTLE FATIGUED; This spontaneous report received from a patient concerned a 55-year-old male. Initial information was processed along with the additional information received from the Organization on 16-JUL-2021 The patient's height, and weight were not reported. The patient's concurrent conditions included chronic non-Hodgkin's lymphoma. Previously the patient had chemotherapy for chronic non-Hodgkin's lymphoma from on an unspecified date in Mar-2020 to Sep-2020. As per the report, currently patient was not being treated for chronic non-Hodgkin's lymphoma, and stated all was good. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little fatigue for about 3 days. On an unspecified date, the patient was tested for antibodies by his oncologist, results found to be none (RRT: Suspected immunological vaccine failure, LLT: Therapy non-responder). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little fatigued and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000186308.; Sender's Comments: V0: 20210733410-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
diarrhea; pain to the bone; chest pain; chills; fever of 102.1 degrees Fahrenheit; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030D21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, QUETIAPINE FUMARATE (SEROQUEL), FENOFIBRATE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), VITAMIN D [VITAMIN D NOS], ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]), PANTOPRAZOLE and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit). The patient was treated with IBUPROFEN at a dose of 1 dosage form and TRAMADOL at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), BONE PAIN (pain to the bone), CHEST PAIN (chest pain), CHILLS (chills) and PYREXIA (fever of 102.1 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102.1 °F (Inconclusive) 102.1 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The patient reported that she felt symptoms 4 hours after the vaccination. She had frozen shoulder, could not move it. There was also a bruise from a vein bein hit from the vaccination.
L upper arm 5 x 5 1/2 cm erythema, swelling, warmth, central injection site visible. No red streaks. KEFLEX 500 mg BID #14 no RF. Ice/heat reviewed. OTC 10% Hydrocortisone TID.
Vasovagal reaction, syncope, hypotension, bradycardia, vomit, pallor, hypoxia.
pruritic rash on left and right forearms (appearing like poison ivy), treated with hydrocortisone cream
Mom reports pt devel sx of resp congestion & low grade temp 36 hrs post vax; 13JUN91 t104 MD felt was rxn to immun;
fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) High and 101.1 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up contains no new information.
I?ve experienced severe allergic reactions to many things. I?m now allergic to soy, yeast, wheat, coffee, casein (dairy) peanuts, green beans/ legumes, eggs, onion and celery. I?ve had a huge rash that broke out on my left arm that started at the spot where I received the injection.  Now I?ve been experiencing my mouth and tongue swelling to the point that my throat has closed up. I?ve been hospitalized as air wasn?t going through my body. I had to inject an Epi-pen in my leg, and be taken to the hospital. I?m currently on high dosage prednisone, Benadryl and several other meds to address the swelling in my tongue that happens daily. I am desperate to find out if there is anyway to stabilize anything that vaccine had in it to see if this condition will get better.
Subjective sense of throat swelling/swallowing. Vitals stable but flushed and elevated BP
10 hours after injection, the adverse event started with sinus pressure and ear pressure and gums/teeth hurting.  Within an hour, my whole body hurt.  My joints felt like they were being crushed in a vice (elbows, hands, knees).  My muscles ached and my back ached.  My jaw ached.  My neck was very sore and I had a headache.  I didn't take any medication (800mg ibuprofen) until 6:30am in the morning (had temperature of 100.4 degrees).  I slept for several hours and felt much better by 10am (approx 22 hours from original injection time).  I was still very tired for another 6 hours, but I was fine after that.
Experienced severe injection site pain at 0300 one week after injection.  Suffered damage to deltoid muscle and sought treatment from Chiropractor consisting of manipulation, massage, laser treatment and ultrasound.  Situation nearly resolved.  Immediately after injection experienced severe stomach issues that have been ongoing.  Reaction to most foods that I have never had a problem with previously.  Sought testing from Dr and all tests were negative.  Discovering that it appears good gut bacteria has been removed by vaccinations and needs to be replenished.  Seeking treatment  from Natural Grocers and dietician.
Patient is a 13 yo male, otherwise healthy, who received his second covid vaccine on Saturday.  He did well until Tuesday morning when he started to have emesis and "chest pressure". He was brought to the ER where work up included a troponin level that was elevated at 20.43. Due to concern for myocarditis, he was transferred and admitted to the hospital for further work up and management.   -Echo results note that the cardiac function and coronaries are normal.  Very trace pericardial effusion -EKG at Good Patient consistent with pericarditis -Repeat troponin 15  Discharged 6/17
CDC reports: 2 yo child developed fever 99.2, local rxn @ inject site & screaming episode following DTP/OPV immunization.
stomach ache; Diarrhea; shoulder pain; lower back pain; feeling unwell; body pain; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 13:45 as a single dose for COVID-19 immunisation. Medical history included leukemia from 2013 to 2018. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medication within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16May2021, the patient experienced stomach ache, diarrhea, shoulder pain, lower back pain, feeling unwell and body pain. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event stomach ache, diarrhea, shoulder pain, lower back pain, feeling unwell and body pain was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Breakthrough case admission /patient expired after 2 vaccines  Moderna 7/21/21 Lot# 078C21A;  Moderna 8/18/21 Lot# 002F21A
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 03-NOV-2012 09:29, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Headache, body aches, chills, fatigue Treated with Tylenol and lots of sleep, resolved after 48 hours.
3 weeks after administration, patient experienced pins and needles feeling in arm and hand (left) that has not resided to this date. It is interfering with her sleep and quality of life.
Case number PHHY2014US068695 is an initial literature report received on 31 May 2014. In this article, the authors presented a case of a five year old female who developed limb swelling after receiving pneumococcal vaccine and meningococcal vaccine conjugate. Her past medical history included sickle cell disease. Her vaccination history included one dose of pneumococcal vaccine (other manufacturer, batch number: not reported) two and a half years earlier and one dose of meningococcal vaccine conjugate (manufacturer: not reported, batch number: not reported) six months earlier. She developed low grade fever after receiving the vaccinations (please see the case PHHY2014US069273). She was vaccinated with pneumococcal vaccine (other manufacturer, batch number: not reported) into her right arm and meningococcal vaccine conjugate (manufacturer: not reported, batch number: not reported) into her left arm on an unspecified date. One day after the vaccination, she developed pain in her head, neck and arm with a fever of 102.9 degrees F. She was treated by her mother with ibuprofen at an unspecified dose. Ten hours later, she developed right arm swelling with oedema which made it difficult to put a shirt sleeve over her arm and at presentation, she also reported nausea. On examination, her right arm was tender with redness and was swollen down to her elbow. She was treated with KETOROLAC at an unspecified dose, ondansetron at an unspecified dose and prophylactic ceftriaxone at an unspecified dose. She was discharged with morphine and ibuprofen at unspecified doses for breakthrough pain. The right arm swelling completely resolved after 24 hours of treatment and the outcome of pain in her head, neck and arm, right arm oedema and tenderness with redness was not reported. The case report scored a three on Naranjo algorithm for determining the adverse events and the authors concluded that it was likely that pneumococcal vaccine caused the adverse event. Additionally, the immune reaction might have been amplified by the conjugated meningococcal vaccine administered concurrently in the other arm.
Case number PHEH2016US0380840, is an initial spontaneous report received from a pharmacist on 20 Nov 2016. This is also a quality complaint report (AQWA number 1018078). This report refers to a 51 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 186868, expiry date: May 2017) at dose of 0.5 ml intramuscularly on 20 Nov 2016. On the same day while vaccination, as the pharmacist injected the last part of injection, it shot out of the syringe and sprayed onto the patient. The pharmacist did not know if it was a faulty syringe or not. The patient did not get the entire dose. The pharmacist was not sure where the leak occurred from. It happened so fast and it just sprayed everywhere. It was reported that the needle and syringe were fully secured together. It was started that, the subject was given second vaccine since the initial dosage leaked during administration (drug administration error) sure if this would constitute a potential over dosage. Upon follow up it was stated that syringe or needle was faulty and did not deliver full dose. No adverse event was reported following this administration error (underdose and accidental exposure to product). Combined follow up report received from pharmacist on 20 Nov 2016 and on 12 Dec 2016: new event added (drug administration error) and updated narrative accordingly. Follow up received from pharmacist on 19 Dec 2016: Added new event syringe issue and update narrative accordingly.
Information has been received from a nurse practitioner concerning a 74 year old male with hypertension, hypercholesterolaemia, depression, and no allergies and a history of coronary artery bypass who on 14-FEB-2007 was vaccinated SC in the right arm with a 0.65 ml dose of Zostavax. Concomitant therapy included TOPROL XL TABLETS, LIPITOR, CELEXA, HYTRIN, and aspirin 81 mg. On 15-FEB-2007, within 24 hours of vaccination, the patient developed a rash. The patient presented to the doctor's office on 15-FEB-2007 with a red, macular rash on both ankles and some on the waist. The right ankle and descending to the lower extremities had eight small macular spots. The left ankle descending to the lower extremities had four macular spots, which were not itchy or tingling. The patient did not have a fever. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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. Past drug history included: Erythromycin, reaction(s): "Known allergies : erythromycin", notes: Known allergies : erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. No other medication in 2 weeks was noted. Covid-19 treatment was noted as Paxlovid. Treatment start date was noted as 28Nov2022 and treatment stop date was noted as 03Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dose of Bexsero that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB398C, expiry date 30th July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's comment: The clinic supervisor reported that a dose of Bexsero was given to the patient and it was already expired. The Vaccine Administration Facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The use of Bexsero dose which was already expired on 30th July 2022, which led to expired vaccine used.
Administered Pediarix, Hib, Prevnar & Rotavirus vaccines at 9:20 am on 1/9/08.  At 9:35 mom stated, "His head is breaking out just like with the Rocephin reaction."  Red rash with hives noted on scalp, no resp distress noted R-34, even & unlabored P 124 Admin Benadryl 4 ml PO  at 9:40.  At 9:45, R-34, P-120, red rash noted on head, no hives noted.  At 9:5o R-36,P-126 decresed redness of rash noted on head, no hives.  At 10:00 R-30, P 120, mild redness on head, no hives.  Pt to home at 10:30, no redness, rash or hives noted on scalp or at injection sites infant sleeping, resp even, unlabored, 28 breaths/min.
p/vax pt devel h/a, body stiffness, dizziness & was instructed to rest & take advil;pt exp intermittent muscle cramping of lt calf, thigh, shoulder & rt lower back;allergic rxn to rabies vax;
Hot Tongue; Redness (Injection Site); Sore Arm; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/vaccination site pain, redness (injection site)/injection site erythema, hot tongue/glossitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the event sore arm.  On 6 Feb 2021, the patient experienced the events, redness (injection site) and hot tongue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm, redness (injection site), hot tongue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Had developed an ache in the left arm. They started with deep innermuscle pain for the first two days, and they felt the limb very heavy and hard to lift. A great pain in the arm as if they had done strenuous exercise.  As of today he still feels pain from the shoulder to the elbow. As if the muscles are always tired.   Has received no treatment to date-- has tried going to specialist and chiropractic to get shoulder massage but the pain is still remaining.
Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles  vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient came down with shingles right after second vaccine. The patient had not any boosters because he/she still afraid of might get shingles afterwards. Additional Supportive Information: The follow up would not be possible since no contact details provided.
Fatigue in waves; headaches; muscle strain in neck and head; occasional metallic taste in mouth; A spontaneous report  was received from a healthcare professional dear concerning a 53-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue in waves, headaches, muscle strain in neck and head, and occasional metallic taste in mouth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events fatigue in waves, headaches, muscle strain in neck and head, and occasional metallic taste in mouth.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events fatigue in waves, headaches, muscle strain in neck and head, and occasional metallic taste in mouth was unknown.
50 year old female presents with 3 days of post nasal drip, nasal congestion, headache and shortness of breath with chest lightness that is worse with lying down.Pt states she received the J and J vaccine in March and the Moderna Vaccine Tuesday 11/23/2021 and started feeling symptoms of headache, post nasal drip, shortness of breath and chest tightness started the next morning. Pt took tylenol cold and flu and cough medicine that her husband had with some relief. Pt denies muscle aches, body aches, nausea and vomiting and fever but she said her kids said she felt warm. Pt denies chest pain and chest tightness at this time and reports the symptoms of chest tightness and shortness of breath are worse with lying down.
Patient started with random muscle spasms throughout her body 2 days after receiving the Pfizer Covid vaccine.  Spasms described as a "fluttering" feeling in the muscle followed by painful cramping lasting approx. 30 seconds. Areas of reported spasms are hands, calves, thighs and back. Spasms occurring every 4-5 days since vaccinated. No history of this type of muscle cramping prior to vaccine.  No treatment administered yet. Will consider lab work if this continues.