chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever /  low grade fever; aches / pains; fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain and fatigue. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and experienced pain, aches, fatigue and fever. The patient was treated with aspirin. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020AMR224651.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223946:same reporter US-GLAXOSMITHKLINE-US2020223951:same reporter US-GLAXOSMITHKLINE-US2020AMR224651:same patient, 1st dose
Per the recommendations of our local health jurisdiction, we are reporting this as an adverse event, since the booster was given after the FDA unauthorized the use of monovalent vaccines as booster doses for individuals 12 years of age and older.
Lymph nodes under left arm swollen to the point of visual bulging from scapula to pectoral.
FEELING DIZZY AND LIGHTHEADNESS; 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced feeling dizzy and lightheadness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy and lightheadness. This report was non-serious.
Shingles, chills, overall weakness.  Swelling at site of blisters
Decreased ability to exercise difficulty having a bowel movement (stool) difficulty with moving flushing or redness of the skin general feeling of discomfort or illness itching, pain, redness, or swelling at the vaccine site muscle aching or cramping muscle stiffness nausea rash swollen joints unusually warm skin  amnesia, confusion, disorientation, restlessness, delirium, drowsiness, seizures, urinary incontinence, urinary retention, constipation, meningismus and/or coma. Increased CSF pressure is present, but chemistry and cell count may be normal. Histopathological changes include perivenous demyelination, microglial proliferation in demyelinated areas with lymphocytic infiltration. atypical chest pain, angina, palpitations, Eczema vaccinatum. Serious skin rashes caused by widespread infection of the skin in people with skin conditions such as eczema or atopic dermatitis. necrosis of the inoculation site pictures are available.  With this noticeable reactions in front of the immunization staff they were convinced that i was ok to proceed to anthrax and meningococcal vaccines on july 27 2013 on top of my already reaction. I felt i was dragged. I attempted to get help but this is no clinic to handle adverse reactions.  I have been hypochondriac and skin red spots comes and goes arthritis pain feeling bouncing pains on off from joint to other places. I feel tire and out of space all the time over three months now. I can get back to where i was.  I have pictures of possible spread of the virus on neck inner thighs...
pt exp red swelling area around inj site, nausea, vomiting, fatigue, temp 102 rx APAP inj ATB:
This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 75-year-old female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, 21 days after receiving Influenza vaccine Quadrivalent, the patient experienced anti-neutrophil cytoplasmic antibody positive vasculitis (serious criteria GSK medically significant), fatigue, dyspnea and lung consolidation. On an unknown date, the outcome of the anti-neutrophil cytoplasmic antibody positive vasculitis, fatigue, dyspnea and lung consolidation were unknown. The reporter considered the anti-neutrophil cytoplasmic antibody positive vasculitis, fatigue, dyspnea and lung consolidation to be related to Influenza vaccine Quadrivalent. Additional information was provided. This case was reported in a literature article and described the occurrence of Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis in a 75-years old female patient who was vaccinated with unspecified flu vaccine (manufacturer unknown). The patient was a healthy female. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified flu vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, 3 weeks after flu vaccination, the patient developed with sudden onset fatigue and extreme dyspnoea with minimal exertion. She had no joint pain or rashes. Complete blood count (CBC) and renal function were both un-remarkable. A computed tomography (CT or CAT) scan showed diffuse bilateral patchy consolidation with coalesced nodularity in the upper and mid lung fields. CAT scan of the chest done 5 months prior to this presentation was essentially unremarkable. All respiratory cultures were negative. Vasculitis workup was positive for cytoplasmic-ANCA (c-ANCA). Treatment was unknown. The outcome of the event was unknown. The author considered the event of ANCA Vasculitis associated with unspecified influenza vaccine. The author stated, "The etiology of ANCA associated vasculitis (AAV) in this case is presumed to be an auto-immune mediated response much like in the idiopathic AAV. However, it is unclear if there is a genetic predisposition for flu vaccine associated AAV." The author concluded, "Although causality is difficult to prove, there is a temporal associated between the flu vaccine, our patient's presentation and her subsequent diagnosis with c-ANCA. By reporting the 9th case of influenza vaccine associated ANCA-vasculitis we hope to add to data that may generate future hypotheses, and epidemiological studies to elucidate the underlying etiology."
feel like you got the flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza (Verbatim: feel like you got the flu). The outcome of the influenza was not reported.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     It was unknown if the company considered the influenza to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023. This case was reported by a patient via interactive digital media. The first shot make you felt like patient got the flu so better to get on a Friday. The follow-up could not be possible as no contact details were available.
Extreme fatigue for 36 hours, headache for 24 hours, sore left arm at injection site, swollen/sore lymph nodes in neck and under arms
Hospitalization for COVID-19 infection with metabolic encephalopathy, POA on dates 8/1/2023- 8/22/2023. Treated with vitamin D 25 mcg PO daily.
N/V, severe frontal headache, elevated BP-180/102 and nose bleeds  Referred to the ED due to her symptoms
Symptoms started 10 days after the 2nd dose. I started to have extreme pain in my extremities, elevated CK levels, very weak, very tired. Pain made it to the point of having hard time walking, numbness in hands. Unable to use hands intermittently.   I have been hospitalized for 6 days, in medical care since receiving the 2nd dose, so many tests run and still have pain and weakness daily. All symptoms I did not have prior to the vaccine.
Allergic reaction to Shingrix / messed up been in an out of urgent care three times; This case was reported by a consumer via media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that received shingrix vaccine and experienced allergic reaction. Also reported messed up in an out of urgent care three times. The patient stated need to take the shingrix off the market. The patient stated that it was 5th August and got the vaccine on 24th August please help. The reported to CDC and also your people took a report.
Heart racing/palpitations; slight lightheadedness.; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) dose 1 via an unspecified route of administration in Arm Right on 23Feb2021 11:15 (at the age of 60 years old) as single for COVID-19 immunisation at public health clinic/veterans administration facility. Medical history included allergy to only MRI contrast. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBICACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported and hormones. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced heart racing/palpitations, slight lightheadedness on 23Feb2021 12:15. Reported as, heart racing/palpitations, slight lightheadedness. This happened within seconds of receiving vaccine. Stopped after 15 minutes. No Treatment was given for adverse event. Patient did not tested for COVID post vaccination. Outcome of the events were recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
scratch; dose 5 (booster); dose 4: Moderna, dose 5: Pfizer; dose 5 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: AH9702) at the age of 58 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (product: Pfizer , lot number: EP6955, dose number: 1, vaccine location: Left Arm), administration date: 22Mar2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (product: Pfizer, lot number: EP6955, dose number: 2, vaccine location: Left Arm), administration date: 12Apr2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (product: Pfizer, lot number: Ft2590, dose number: 3, vaccine location: Left Arm), administration date: 29Oct2021, when the patient was 57-year-old, for Covid-19 immunization; moderna (product: Moderna, lot number: 033K212A, dose number: 4, vaccine location: Left Arm), administration date: 01Apr2022, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Sep2022, outcome "unknown", described as "dose 4: Moderna, dose 5: Pfizer"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 21Sep2022, outcome "unknown" and all described as "dose 5 (booster)"; SCRATCH (non-serious) with onset 04Oct2022 at 21:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of scratch. Additional information: Patient was tested positive for COVID-19, developed fatigue, scratch through on 04Oct2022. On 05Oct2022, development more cold & Flu-like symptoms and took COVID-19 home test and tested positive. Report of test result to reporter on 05Oct2022. Patient believed to have been exposed to Covid at a school reunion on 01Oct2022. Reportedly, so far, 9 of 13 attendees at the dinner table that night have tested positive for COVID-19.
pt recv vax & devel inj site rxn characterized by redness, swelling & warmth;THis is 1 of 7 employees of this facility to have an adverse exp p/vax lot# 4978167;
Initial reaction on day of vaccine was severe abdominal pain and nausea with vomiting for about 24 hours.  Over the next several months developed food and odor sensitivities.  February 2022 diagnosed with IBS with much abdominal and distress, diarrhea and weight lose.  Began dietary modifications and supplementation to reduce/eliminate symptoms.  Quickly developed Chronic Fatigue and severe, chronic pain in back and legs. Prescribed anti inflammatory and pain medications which eased but did not resolve symptoms.  All symptoms continued to some degree.  In July, had sudden attack of severe, incapacitating  vertigo and nausea which kept him bedridden for 3 days.  He continued to lose weight.  On August7, he had a seizure and was transported to ER via EMS.  He died Aug 8, 2022 from a brain aneurysm.
has Fever/Rash on 10/16/2019; has Fever/Rash on 10/16/2019 / full body rash; Measles antibody IgG, Rubella antibodies IgG and Mumps ABS IgG came back low( less than 13.5); had developed chicken pox after receiving the MMR II vaccine; This spontaneous report was received from an office manager referring to a 47 years old male patient. The patient's medical history included insomnia and negative for Immunocompromised condition. The patient's historical drug included neomycin, gelatin and gelatin containing products. The patient's historical vaccine included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Wistar RA 27/3) (M-M-R). The patient had no allergies/no previous reaction to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Wistar RA 27/3) (M-M-R), neomycin, gelatin or gelatin containing products. The patient had not immune suppressed. The patient not received an antibody-containing blood product in previous 11 months and had no history of thrombocytopenia or thrombocytopenic purpura. Concomitant therapies included lorazepam (ATIVAN).   On 03-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin (rHA)) (single dose, 0.5 milliliter formula) subcutaneously in the left arm for prophylaxis (reported as titers were done and measles antibodies IgG came back low).  Reconstitute with sterile diluent (lot# S016863; expiration date: 02-APR-2022; dose, strength unknown). All the suspects were stored in correct temperature storage range.   On an unknown date in October 2019, the patient developed chickenpox after receiving the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  On 16-OCT-2019, the patient experienced fever and rash.  On 17-OCT-2019, the patient experienced full body rash. Antibody test showed Measles antibody IgG, Rubella antibodies IgG and Mumps ABS IgG came back low (less than 13.5). The patient went to the emergency room for medical attention and treatment was provided for the adverse event. The outcome of all the events was reported as recovering. Causality assessment was not provided.
RECEIVED THE VACCINE TWICE/VACCINE OVERDOSE; This spontaneous report received from a pharmacist concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included cataracts, fracture of lower leg, pruritic rash, and pterygium, and concurrent conditions included allergic rhinitis, chronic pain, hypertension, nicotine dependence, osteoarthritis of knee, tobacco use/smoker, rosacea, non dependent alcohol abuse, and alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. the patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 23-JUN-2021, and dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. The first dose batch number was not reported and has been requested. No concomitant medications were reported.  On 12-JUL-2021, the subject experienced received the vaccine twice/vaccine overdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received the vaccine twice/vaccine overdose was not reported. This report was non-serious.
Events: swollen lymph nodes (lymphadenopathy) under arms. lymph nodes are swollen, red, and tender/painful. Painful lymph nodes are uncomfortable when trying to sleep. Some fatigue and tiredness. Low injection site pain. Treatment: None. No pain relievers or NSAIDs Outcomes: swollen lymph nodes increased in pain through the week after the 2nd dose. Lymph nodes remain swollen, but pain seems to be slightly reduced after a week.
patients sometimes do not return for 2nd dose of Shingrix; This case was reported by a pharmacist via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter mentioned that, the patients sometimes did not return for 2nd dose of Shingrix because they experienced adverse events following the 1st dose, which led to incomplete course of vaccination. The reporter could not tell specific number of patients, but if she had to estimate she would say maybe around 10 patients. The reporter did not consent to follow-up. This case had been linked with US2021AMR101781, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101781:husband´s case, same reporter
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 25-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis, lot # R012550 and expiration date 25-JAN-2020 (dose, strength, frequency, and route of administration were unknown). On the same date, the patient went to the pharmacy and received a dose of influenza virus vaccine (unspecified)(manufacturer unknown)for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were unknown); and a second dose (overdose) of PNEUMOVAX 23 for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were unknown). No adverse effects were reported.
Admitted for severe dehydration & mild rhabdo; profound continued weakness prompted infectious causes and pt COVID+; was treated w/steroids, abx, remdesivir & O2, weaned to RA. Due to weakness, pt dc'd to rehab
Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.  Letter was returned to sender on 3/1/23.
Tachycardia accelerated heart rate more than 125. It was around 4 days. But the cardiologist had to increase the dose of the medicine.
No adverse event; patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine).    No concomitant medications were reported.  HCP reported that a patient received the Monovalent expired vaccine on 04-Oct-2022 and Patient didn't experience any side effects.   It was reported that dose was administered 30 days after date of expiry. Vial size was mentioned as 5.5 ml. The vial was stored in the refrigerator on 07-Sep-2022 and The Vial didn't undergo temperature excursion study.
I experienced an unsettling metallic / bitter taste in my mouth about two days after vaccination. (It?s now lasted for six hours and counting).  I called an urgent care / telehealth line and am relieved to hear it?s not something to worry about unless it persists for a very long time - like 2 weeks. But I wanted to report the symptom here so that hopefully more people are aware that this is a possible side effect - and that it can appear well after vaccination day. It?s not listed on the handout I received. For what it?s worth,  I didn?t have this reaction to the first shot which is a little puzzling.  Anyway - hope this helps!
Blisters formed on skin on the right side trapezius area. Blisters were itchy and broke open when scratched to release clear fluid. Patch of blisters was about 4 inches wide/long and lasted about 5 days before drying/clearing up.
Patient had cataract surgery on 5/17/2021 on her left eye. She received her second COVID shot (Moderna) on 5/21/2021. Saturday night she started feeling under the weather. Sunday morning she had cloudy vision in her left eye. Monday her vision was almost completely gone. She was seen by the doctor that did her cataract surgery and he said that the vision loss was due to constricted vessels in her eye and that was caused by the COVID shot. The patient's vision has since fully recovered.