chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stiffness in spine/my spine is stiff and I am having trouble moving around; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in spine/my spine is stiff and I am having trouble moving around) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Degenerative disc disease, Pericarditis, Asthma, COPD and Bronchitis. Concurrent medical conditions included Drug allergy (yellow dye sulfa), Penicillin allergy, Drug allergy (codeine) and Drug allergy (coconut).    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in spine/my spine is stiff and I am having trouble moving around). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in spine/my spine is stiff and I am having trouble moving around) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Historical condition include TIAs.  No relevant concomitant medications were reported.  No treatment information was provided
rt hemiparesis, tremors of extremities, irritability;MRI showed bilat involvement of  basal ganglia;
Achy/like she was being stabbed; Lungs felt tight; Hard to move arm that was injected due to the pain; Dizziness; Headache; Feeling tired; Arm that received the vaccine swollen; Arm that received the vaccine very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy/like she was being stabbed), LUNG DISORDER (Lungs felt tight), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move arm that was injected due to the pain), DIZZINESS (Dizziness) and HEADACHE (Headache) in an adult 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 information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Achy/like she was being stabbed), LUNG DISORDER (Lungs felt tight), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move arm that was injected due to the pain), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Feeling tired), VACCINATION SITE SWELLING (Arm that received the vaccine swollen) and VACCINATION SITE PAIN (Arm that received the vaccine very sore). On 13-Mar-2021, HEADACHE (Headache) had resolved. On 14-Mar-2021, PAIN (Achy/like she was being stabbed), LUNG DISORDER (Lungs felt tight), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to move arm that was injected due to the pain), DIZZINESS (Dizziness), FATIGUE (Feeling tired), VACCINATION SITE SWELLING (Arm that received the vaccine swollen) and VACCINATION SITE PAIN (Arm that received the vaccine very sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Approximately 7 cm x 5 cm hard, eryethematous, hot tissue reaction around inoculation site on R thigh.  Non-fluctuant.  No fever. Lump was painful.
Information has been received from two medical assistants concerning a 17 year old female who in July 2007, was vaccinated with the first dose of GARDASIL. In November 2007, the patient was vaccinated with the second dose of GARDASIL. In April 2008, the patient was vaccinated with the third dose of GARDASIL. The medical assistants reported that the patient came back to the office in July 2008 for her annual checkup and had "abnormal pap atypical squamous cells of undetermined significance". The patient also had a colposcopy. The outcome was unknown. The patient saw the physician to seek unspecified medical attention. Additional information has been requested.
Wheezing, tired, fever of 101.4, chills, muscle and joint pain, severe headaches, extreme nausea , swelling, itching and redness at injection site.
Fever ranging from 101-103.5 for 2.5 days, extreme soreness and lack of ability to move arm where injection occurred, extreme swelling and redness that grew to cover entire upper arm over 3 days, arm pain for 9 days.  Prescribed 10 day course of antibiotics.
Case number PHEH2017US005138 is initial spontaneous report received from consumer on 15 Feb 2017. This report refers to 17-year-old female patient (weight-72.3 kg and height- 160.3 cm). The patient's medical history included: hematochezia, teratoma. FLUCELVAX QUADRIVALENT was administered on 08-Oct-2016 (Dosage: 0.5ml, route of administration: intramuscular, batch number: 185327, expiry date: 30-Apr-2017). After administration of FLUCELVAX QUADRIVALENT, on 15-Feb-2017 the patient experienced influenza (Seriousness criteria: Medically Significant), (Outcome - recovered), Associated Symptoms: cough, fever, chills, sore throat. It is reported that patient experienced flu because of vaccination failure. This was considered as vaccination failure (seriousness criteria: medically significant), (outcome - not reported). Batch review report (1021211) received from quality assurance department on 03-Jun-2017: Based on the document review, it was stated that the concerned FLUCELVAX QUADRIVALENT, batch number: 185327 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Treatment medications: TAMIFLU is administered for flu. The Consumer assessed the events as serious (medically significant) and the causality related (possibly) for vaccination failure and not related for Influenza. This case report was considered as serious (medically significant). Follow up received on 12-Apr-2017: Added reporter's details, updated patient details (height, weight and race), medical history (hematochezia, teratoma), added treatment drug (TAMIFLU), added events vaccination failure and influenza with symptoms (influenza with symptoms fever, chills and sore throat), updated outcome and causality for the events, accordingly updated narrative. Follow up received on 03-Jun-2017: Start date, batch number and expiry date of suspect vaccine was updated and batch review report (1021211) from quality assurance department was updated.
Myalgia, Phlebitis, woke up with pain in right thigh and lower leg. warm to touch. not evaluated. Referred to UC/ER.
Given at 9AM DTAP to the right thigh noted small amount  of redness to the site. Called mom to check on her at 10AM and she stated more redness and swelling she came back to the clinic noted site reaction to rt leg 5 x 8 cm gave Benadryl PO & Prednisole at 2 pm mom stated much better on 8/14/2019 1 am started resolved
TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced HEADACHE (TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE). In 2021, HEADACHE (TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE) had resolved.            No concomitant medication was reported.  In 2021, the patient experienced TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE. In 2021, the TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE resolved. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was not available.    Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a physician refers to a 5 and a half year old female patient. On 23-SEP-2014 the physician stated that the patient received inadvertently GARDASIL dose 1, intramuscular (lot# and exp date was not reported). Not adverse event reported. Additional information has been requested.
Approx, 4-5 days later experience neck pain & swollen lymph glds in neck & around ears. Symptoms progressed to severe arthralgia in joints, knees, ankles, wrists & fingers. Became difficult to walk, up down stairs & to hold onto objects. Broke out in rash red dots over legs, chest, and stomach.
?Covid arm? rash, delayed reaction by one week. Rash. Is about 6 inches in diameter
she received the full dose of the Moderna COVID 19 vaccine instead of the half dose for the booster; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (she received the full dose of the Moderna COVID 19 vaccine instead of the half dose for the booster) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (she received the full dose of the Moderna COVID 19 vaccine instead of the half dose for the booster). On 24-Jan-2022, ACCIDENTAL OVERDOSE (she received the full dose of the Moderna COVID 19 vaccine instead of the half dose for the booster) had resolved.            No concomitant medications were reported.  Treatment information was not provided by the reporter.  She confirmed that she was not immunocompromised.  The batch number for third dose was reported as 042J21A or 042C21A (could not see the writing very well).
including any and all of its sequelae/ other related health complications; shingles; Information has been received from a lawyer referring to a 62 years old female (inconsistent information, also reported as he) patient regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On 08-NOV-2016 (when she was 60 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in February 2018, the patient was caused to suffer serious and dangerous side effects including shingles and any and all of its sequelae(also reported as other related health complications) (ill-defined disorder), as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. In addition, the patient required and would continue to require healthcare and services. The patient also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. The patient had incurred and will continue to incur mental and physical pain and suffering. The outcome of the events was considered to be not recovered. The causality assessment between these events and zoster vaccine live (ZOSTAVAX) was related.   The lawyer considered the events shingles and ill-defined disorder to be disability.
The symptoms of my Tinnitus were a sensation of fullness and began after my second dose which was in April and the symptoms begin around July in 2021. They weren't significant but were noticeable. November 27th, I received my 3rd dose of Moderna. I noticed the symptoms getting worse in December and January. It hasn't gotten any better or worse at this point in time since back then. I went and seen an ENT. They checked my eustachian tubes which were normal. A hearing exam was doing which came back normal with no problems. They requested a MRI to see if I had a brain tumor and the MRI came back negative. I went to a surgeon to see if the issue was related to my TMJ which they also did an MRI for. Both MRI's on my brain came back negative. I got braces for my teeth because I thought the issue could be in relations to my teeth. All of that happened between December up until March 2022. The Tinnitus is not debilitating but is annoying.
Patient presented to COVID-19 Vaccine clinic on 02/06/21. Patient reported the following allergies on immunization consent form: "cefdinir - anaphylactic". Patient took diphenhydramine (dose unknown) at ~4:00pm prior to appointment. Patient received 0.3mL Pfizer COVID-19 Vaccine at 4:17PM from pharmacist. Pt. noticed she was developing hives and itching. Nurse at vaccine clinic was monitoring and called EMS. At 4:47PM, patient reported difficulty swallowing and had facial hives. Epi-pen was administed by pharmacist - per Immunization Emergency Protocol. At 4:50pm, EMS arrived at clinic, and patient was taken via ambulance to emergency department for further treatment at 4:53pm. Current status unknown.
I became aware that my sister was exposed to and tested positive for COVID (I assume at work as she is a nurse) after she had received the initial dose of the COVID-19 Pfizer vaccine; I became aware that my sister was exposed to and tested positive for COVID (I assume at work as she is a nurse) after she had received the initial dose of the COVID-19 Pfizer vaccine; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received first single dose of BNT162B2 (Manufacturer: Pfizer, solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. Patient had no prior COVID vaccination. The reporter became aware that her sister was exposed to and tested positive for COVID (she assumed at work as she was a nurse) on Jan2021 after she had received the initial dose of the COVID-19 Pfizer vaccine. She was not sure when the exposure took place, but it had been about 3 weeks since she received the first dose. Patient was tested post vaccination. The outcome of events was recovering.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Patient received Pfizer COVID vaccine on 4/29/21 (lot # EW0171), 5/20/21 (lot # EW0182), and 12/29/21 (lot # FE3594). On 1/11/22, patient admitted to our inpatient facility with hypovolemic shock (in the setting of poor PO intake of 5 days), acute renal failure CKD stage II, and positive COVID test result (generalized weakness without any respiratory symptoms).  During hospitalization, patient was also found to have calcific debris/small stones in distal left ureter with hydronephrosis, which will most likely pass per nephrology. As of today (1/13/22), patient is still hospitalized in our med/surg unit due to acute renal failure and  without any respiratory COVID symptoms (CXR clear).
Screamed uncontrollably x 5-6 hrs straight eve w/APAP; red swollen leg from knee to hip sl temp next day;
No additional AE/PQCs reported; Caller informed Agent of the administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 05-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) (lot # T015598 and expiration date reported 02-NOV-2021) (dose, route, and anatomical location were not reported) for prophylaxis.  According to the reporter, the temperature was 20.5 degrees Fahrenheit for a time frame of 1 hour 54 minutes. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) vaccine had a previous temperature of excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3 degrees Fahrenheit) for 23 hours, which was detected by a digital data logger. No additional adverse event (AE) was reported.
Pt recv vax on unknown day;  post vax pt exp fever, flu-like sx, swelling/red/itching/ warm vax site
Fifteen minutes after shot, I felt dizzy and warm. One hour after shot my left arm started hurting. Four hours after shot, I started having severe arm and leg pains. Then came fever of 101, severe chills, and fatigue. I was in bed by 8pm and awoke feeling much better but legs were still aching. Left arm hurts so bad I can't lay on it without it waking me up. There is no swelling or redness at the injection sight though.
Pharmacy recall. Product sent short dated 9/30/2022 and vaccine was given in 10/10/2022
Fever 39.5 degrees C resistant to Tylenol and Ibuprofen. Muscle pain, Back pain, Injection site pain. Blurred vision, Shortness or breath (water retention in lungs while sleeping). Chest pain, numbness at extremities. Runny nose
got both doses in late Apr2021 and in the middle of Jul found out I have a heart murmur now; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored Regulatory Authority Support and medical information team.  A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECG COVID-19 mRNA VACCINE), via an unspecified route of administration in Apr2021 (Lot number and Expiry date was not reported) as dose 2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 via an unspecified route of administration in Apr2021 (Lot number and Expiry date was not reported) as dose 1, single for Covid-19 immunization. It was reported, the patient had both doses in late Apr2021 and in the middle of Jul2021 the patient found out he have a heart murmur now (at the time of report). It was reported, he had undergone some tests and scheduled to have mitral valve replacement surgery because of this in the upcoming week (at the time of report). It was reported he got moved to front of the list (further details not specified) because it was so bad. The outcome for the event was not reported.   The lot number for BNT162B2  was not provided and will be requested during follow up.
I did not receive the vaccine, my husband did but even though he is having trouble sleeping and rashes I am reporting the effects on me, about 1 month after his second dose of moderna I had my period twice even though it had already stopped, after 2 months I caught an eye infection and rashes in the upper chest and under my breasts, one week after it started I took ivermectin used antibiotic gel for the eyes and triamcinolone acetonide cream for the rash, it did not help much. Last night  I couldn't sleep well, I woke up about 3 a.m. and did not go back to sleep, I took iboprofen 200 mg yesterday and today because  I had pain in my right cornea, I also have swelling around the eyes. I am now avoiding physical contact with my husband and tomorrow I will call my doctor. I am sure my symptoms are because of the vaccine my husband took because I was healthy before.
The injection was given at 2 pm. Adverse outcomes began shortly after the injection: severe pain at the point of injection: immediately after the injection. Severe pain in the arm so that by 7pm (five hours after the injection) the arm could not be raised. Severe headache (7pm - 5 am). Temperature 102 degrees Fahrenheit (1 am - 5 am). Cramping legs (10pm - 5am). Severe nausea (3 am - 5 am).
p/completing all capsules, 48 hrs later started swelling of the eye & wrist swelling & the following day swelling on forehead;
Interchange of vaccine products; Revaccination with different COVID-19 vaccine; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant and treatment medication provided This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Arthralgia CHILLS, INJECTION SITE PAIN AND SWELLING AND PURITIS Narrative: