chrisvoncsefalvay/vaers-outcomes huggingface dataset:
getting up to go to the bathroom about every hour; It started getting worse; had a strain of coronavirus in December 2021 right before holiday/tested positive with coronavirus; Lack of drug effect; had a sinus infection/coughing from sinus infection; she was in bed; lung infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (lung infection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ATORVASTATIN for an unknown indication.    Concomitant products included METFORMIN, RAMIPRIL and ATENOLOL for an unknown indication.   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 started ATORVASTATIN (unknown route) at an unspecified dose. In 2021, the patient experienced PNEUMONIA (lung infection) (seriousness criterion medically significant), SINUSITIS (had a sinus infection/coughing from sinus infection) and BED REST (she was in bed). In December 2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (had a strain of coronavirus in December 2021 right before Christmas/tested positive with coronavirus). On an unknown date, the patient experienced POLLAKIURIA (getting up to go to the bathroom about every hour) and CONDITION AGGRAVATED (It started getting worse). At the time of the report, PNEUMONIA (lung infection), DRUG INEFFECTIVE (Lack of drug effect), SINUSITIS (had a sinus infection/coughing from sinus infection), BED REST (she was in bed), POLLAKIURIA (getting up to go to the bathroom about every hour), COVID-19 (had a strain of coronavirus in December 2021 right before holiday/tested positive with coronavirus) and CONDITION AGGRAVATED (It started getting worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Laboratory test: results not provided Results not provided. In December 2021, Coronavirus test: positive (Positive) Positive.         It was reported that the patient had tests and was sent home with 2 prescriptions, and was asked to stay home and quarantine. She was in bed. She was therefore unable to get her booster dose at that time. After starting Atorvastatin, about a month into it, she had to get up about every hour to go to the bathroom. For example, if she went to bed at 10 PM, she got up at 11:30 PM to go the bathroom, and about every hour from then on. It was reported that the patient did not experience any symptoms after receiving first two doses of the Moderna COVID-19 vaccine.
Left side of body (the side of the body of the injection site) numbness, pain, and tingling on my Face, Arm, Neck, back, foot and leg. These symptoms have been present every day since the injection 7-3-2021 to current (7-13-2021)
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On 19th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm and injection site erythema were unchanged and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The reporter was the nurse and patient herself. At 13:00, the patient received SHINGRIX subcutaneously instead of intramuscular route, which led to incorrect route of vaccine administration. On the day of reporting, in the morning, she noticed she had a sore arm and redness at injection site covering 2 by 2 inch area. No further details were provided. The reporter gave permission to contact their healthcare provider. The case was transferred to medical information team for further information on subcutaneous administration of vaccine.
*Pain at injection site; 10 hours after injection; lasted 48 hours *Myalgia, primarily in shoulders;  12 hours after injection: lasted 24 hours; Ibuprofen 400 mg *Chills; 14 hours after injection; lasted lasted 15 minutes *Joint pain (hip, knee): 12 hours after injection; lasted 24 hours *Diarrhea; 72 hours after injection; lasted 6 hours; unsure if related
I received my Covid-19 vaccine on 10/29/2022. On 01/10/I tested positive for Covid-19. I started getting a headache, sore throat and congestion. Symptoms were mild. Symptoms lasted about 2 weeks.
Caller stated that she received 5 Pfizer immunization shots and the last one the omicron booster shot on 05Nov2022 (Lot number GJ6796), she was diagnosed covid positive; Caller stated that she received 5 Pfizer immunization shots and the last one the omicron booster shot on 05Nov2022 (Lot number GJ6796), she was diagnosed covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GJ6796) for covid-19 immunisation; BNT162b2 (BNT162B2), 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, and all described as "Caller stated that she received 5 Pfizer immunization shots and the last one the omicron booster shot on 05Nov2022 (Lot number GJ6796), she was diagnosed covid positive". The patient stated that she received five Pfizer immunization shots. On Saturday, Nov2022, the patient was diagnosed COVID positive shortly after receiving the last Pfizer COVID shot. The patient wanted to know if the COVID vaccine has an interaction with Paxlovid. The patient also asked if there are reports of contracting the COVID virus even though five COVID-19 shots were received, considering that the last shot was the omicron shot. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: she was diagnosed covid positive on Saturday. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
RCD VACCINE AT 10AM 6.15.05 AT 10PM SAME DAY DEVELOPED FINE RED RASH TO FACE, HA, VERY TIRED, VOMITING. TODAY STILL WITH HA, VERY TIRED AND WITH RASH STILL, THOUGH IT IS FAINTER.
Mild Injection site pain; chills; body aches; Dose number=3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jan2022 17:00 (Lot number: FE3594) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin family of antibiotics" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207), administration date: 26Apr2021, when the patient was 46 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318), administration date: 05Apr2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 17:00, outcome "unknown", described as "Dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 06Jan2022 07:00, outcome "not recovered", described as "Mild Injection site pain"; CHILLS (non-serious) with onset 06Jan2022 07:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 06Jan2022 07:00, outcome "not recovered", described as "body aches". Therapeutic measures were not taken as a result of vaccination site pain, chills, pain.  No follow-up attempts are possible. No further information is expected.
Pt. states that after receiving the 3rd Booster of Moderna 11/02/2021, started experiencing symptoms that evening of headache, fatigue, nausea, dizziness, and rash on the legs and both arms between wrists and elbows (red dots) itchiness. No noted Primary visit/communications.
arm started to get red at the injection site; arm swollen, at the injection site; arm, itchy at the injection site; Tiredness; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 5th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th November 2021, several hours after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching, tiredness and dizziness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were not recovered/not resolved and the outcome of the tiredness and dizziness were recovered/resolved.   The reporter considered the injection site erythema, injection site swelling, injection site itching, tiredness and dizziness to be related to Shingrix.  Additional details were reported as follows: The patient had reported that he was administered with first dose of Shingrix on 11-May-2021 and few hours later his arm started to get red, swollen, and itchy at the injection site (left arm).  He also stated that about 10 hours later, he started with tiredness and dizziness. The patient reported that the events dizziness and tiredness had resolved but rest events persisted. The patient had reported that he also received Johnson and Johnson Covid vaccine 3 weeks prior reporting the event in the right arm. The reporter was asking if this was expected, why this was happening, and what he could do to get it to resolved. The reporter had not consented to follow up. No health care information was provided.
No additional AE reported; PROQUAD was administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not provided.  On 04-APR-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 0.5 ml, lot #U029148, expiration date: 16-MAR-2023 (anatomical location and route of administration were not provided) for prophylaxis (product storage error). The vaccine was stored at a temperature of 25.7 degrees Fahrenheit (F) for 2 hours and 36 minutes. The vaccine did not undergo previous temperature excursions. No additional adverse event was reported (no adverse event).
Muscle cramping; Muscle twitching; This is a spontaneous report from a contactable consumer, the patient. A 30-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 01Jun2021 at 17:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had no known allergies. Concomitant medications included cholecalciferol (VITAMIN D3) for an unknown indication and birth control medication; both from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021, at 21:00 the patient experienced muscle cramping and muscle twitching following 1st dose of Pfizer COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle cramping and muscle twitching was not recovered at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Right ARM got red and puffy, according to Pt. on the next day.  Started out "quarter-size".  Progressed to "Golf ball-size" on 3rd day.  Warm.  No other symptoms, however.  She took Only 1 Benadryl and didn't work immediately, so called Ask a RN and went to E.R.-was told to take acetaminophen by RN, and Dr. at E.R. had told her to get on Benadryl course before leaving our pharmacy, upon vaccination.
Patient had large red swelling (entire deltoid section of upper arm) around the injection site; reaction was swollen and warm to the touch. Patient complained that it was very uncomfortable.
A company representative reported that a child received an injection of Prevnar. That evening, the child developed irritability, restlessness, and redness/flushing of the face. No further information was available at the date of this report.
2 YO received Kinrix; Kinrix dose was this patient's fourth DTaP dose and third IPV dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included DTap (last DTap dose 1 year ago) and IPV (IPV dose was 2 years ago).   On 28-MAR-2023, the patient received Kinrix. On 28-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 YO received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix dose was this patient's fourth DTaP dose and third IPV dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 29-MAR-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up, though did not wish to provide last name and did not have an email address to provide. The reporter consented to follow up. The patient received a dose of Kinrix as fourth DTaP dose and third IPV dose at inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Leg started swelling 4/22 and became painful.  Saw Dr. on Monday 4/26 and had venous ultrasound which showed a "blood clot"  was started on xarelto
Noticed a mass in R arm along bicep beginning around July 10, 2021.  Sought diagnosis/treatment.  Underwent x-ray, MRI, Chest CT, US guided biopsy, PET/CT & Bone Marrow Biopsy. Diagnosis of Marginal Zone Lymphoma received on 10/19.  Radiation treatment completed on 12/17.
Narrative: A 79yo male with PMH of Goiter Nodule, GERD, Vitamin D-Deficiency, ADHD, Sensorineural Hearing Loss of Combined Type, Cerebral Infraction due to Embolism of Middle Cerebral Artery, Depressive Disorder, Venous Insufficiency of Leg, Fall, Hyperlipidemia, Right Hemiparesis, Mild Cognitive Decline, Long -term current use of anticoagulant, Chronic A-Fib, Walking dysability, Frontal Lobe Syndrome, Malignant Neoplasm of Urinary Bladder/Papilary Urothelial Cancer, Pressure Ulcer on Sacrum, OA, Tubular Adenoma, Dysarthria, Dysphagia, AKI on CKD, DM2, Foot Gangrene, HTN, OSA, Bladder Cancer, On December 13, 2021 the attending physician reported patient declined in mental and physicial status soon after receiving covid-19 vaccine Patient's immunization record showed, he received Covid -19 vaccin In 2021 on January 14, February 4 and November 22
I started having pain in my heart and back. I went to doctor. I was hospitalized over night. They blood work, normal results. They did EKG, normal results. They did an Echocardiogram, normal results. They did a CT scan of my heart, normal results. They thought it was caused by the vaccine. These symptoms lasted for about 45 days.
Chronic fatigue syndrome; This case was reported by a consumer via call center representative and described the occurrence of chronic fatigue syndrome in a 67-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included depression. Previously administered products included Prozac (started to receive at the age of 50 years).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced chronic fatigue syndrome. On an unknown date, the outcome of the chronic fatigue syndrome was recovered/resolved.   It was unknown if the reporter considered the chronic fatigue syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The patient had experienced depression periodically throughout her entire life but as she started taking Prozac at 50 years old, she had not been depressed since.  The age at vaccination was not reported but it could be 56 years or 57 years. 10 years ago from the date of reporting, the patient experienced chronic fatigue syndrome after getting a flu vaccine. She did not remember what flu vaccine it was.  It took 9 months to recover from the fatigue. The patient also received Shingrix and experienced some adverse events, refer case US2019116950 reported by the same reporter. The patient did not consent to follow up. There is a discrepancy with respect to the outcome of the event chronic fatigue syndrome. In source document, the outcome is reported as recovered/resolved with sequel, however as per narrative description it is recovered/resolved. The outcome of the event retains as per the narrative description.
body aches, chills, awakened @ 0300;fine by 0800 28OCT97;felt fine;then 29OCT97 had hand surgery;30OCt97 had T101.0, achy, chills x 24hr;
The day after the vaccine I woke up with tingling in my right hand thumb and forefinger.    over the next couple of weeks the tingling would move around the hand and forearm.   I also started experiencing my face turning red.     I had been building a playground in the backyard with power tools and plenty of sun during the unseasonably warm March, so i assumed the symptoms were related to some sort of physical strain.     However, after an appointment in April to review symptoms, and follow-up with my primary doctor in May, i'm not being referred to neurology for review.   I don't have a diagnosis, only symptoms at this moment that line up closely to the vacation but also line up closely to an out door home project.   The symptoms are intermittent but are moving to more of a daily basis.
Patient declared deceased the day after receiving second Moderna COVID vaccine. not her regular pharmacy to our knowledge. Have attempted to contact last known PCP with no response. Son notified pharmacy of patient passing away.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Health Authority (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA277871, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  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 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.
pt adm w/bacterial meningitis 24DEC95 causative organism Haemophilus influenza (CSF cult 24DEC95);
On 6/5/95, pt was vaccinated with varicella virus vaccine live and on 2/1/00, the pt developed varicella consisting of > 50 lesions on his trunk with several lesions around the pt's eyes. At the time of the report, the pt's symptoms were still being treated; no medications were prescribed. Follow up states on an unspecified date the patient recovered.  No further information is available.
pt recv vax; a week later, pt was dx w/ acute lymphocytic leukemia and underwent tx w/ acyclovir and chemotherapy;subsequently devel a diffuse rash;one MD felt it was chicken pox rash, the other  did not;
Aches and pains in all joints. Hoarseness. Lost voice for 4 or 5 days. Weakness/tiredness breathing problems
No adverse event reported by the patient. Patient notified on the day of vaccination of incorrect doses. Followed up with pt three days later and no adverse reactions reported.
Patient can't lift left arm any higher than a few inches without pain. She saw Dr. on 10/9/15 and was given methylprednisolone taper. She felt good while taking it but arm hurts again. She has been trying to go about her business and is 80 percent better but still having pain trying to curl her hair.
AFLURIA given in left arm on 10/13/11. Rash developed in area of shot about 10/29/11. Localized rash, redness, itching still evident as of 11-5-11.