chrisvoncsefalvay/vaers-outcomes huggingface dataset:
elevated WBCs; 103 fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (elevated WBCs) and PYREXIA (103 fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (elevated WBCs) and PYREXIA (103 fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, WHITE BLOOD CELL COUNT INCREASED (elevated WBCs) and PYREXIA (103 fever) outcome was unknown.            Treatments for the events included Ibuprofen and paracetamol.
*within 3 hours - developed headache.  Took max OTC dose of alternating ibuprofen and tylenol to manage pain. * for next 36 hours - headache continued, pain in extremities, chills.  Took max OTC dose of alternating ibuprofen and tylenol to manage pain *at 48 hours post vaccine - symptoms seemed to subside * on day 3, rash appearred on back (shoulder blade closes to the injection site).  Small itchy blisters that are a bit tender and sometimes burn.  Uncertain if these are a rash or something else at this time. Based upon other lack of exposure (no sun, no change in detergents, etc), I attribute this rash to the covid vaccine.  I am not yet convinced this is a rash or the onset of shingles.
shortness of breath and chest pain have subsided; Dizziness; swelling underneath my armpit; not feeling well; nausea; This is a spontaneous report from a contactable consumer. This 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 43 years) as a single dose for COVID-19 immunization. The patient's medical history included shortness of breath and chest pain. The patient's concomitant medications were not reported. On 06Feb2021, the patient experienced dizziness and it was getting better. On an unspecified date in Feb2021, the patient experienced nausea and was not feeling well. The nausea was getting better. Last night (on the day of reporting), the patient had a little bit of swelling underneath his armpit. The swelling under the arm had improved previous day night. On an unknown date, the patient underwent COVID test and shown negative results. The shortness of breath and chest pain had subsided after the patient got vaccinated. The outcome of the events was recovering.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reaction or allergy who on 01-JUN-2011 was vaccinated with the first dose of GARDASIL (Lot number: 1511Z; expiration date 26-APR-2013). There was no concomitant medication. On 02-JUN-2011 the patient developed a pruritic maculo-papular rash, "2" X 2"", at the injection site, with bruising, some induration, and 2mm papules that were almost vesicular in appearance. On 03-JUN-2011, the itching was "not as bad". No treatment was given. No lab diagnostics study was performed, the patient called the physician. The physician instructed the patient to "keep an eye on it" and to let the physician know if anything changed or worsened. At the time of the report, the patient's present status was unknown. Additional information has been requested.
Received Pediarix, #2 Prevnar, and #2 Hib on 3/29/04 approximately 8:30 AM. Arrived in ER at approximately 7:00 PM via EMS. Temperature 102.8, irritable and difficulty breathing. WBC 31,700; appeared clinically well and UA borderline. Because of labs, admitted. Discharged on 4/2/04. Decreased temp, good appetite, blood culture, UA culture and CSF negative.  Nurse follow up on 06/17/04 states: "Elevated WBC's."  Nurse follow up on 08/30/04 states: "No new information."
I got sick recently with abdominal pain, uncontrollable diarrhea and vomiting, passing blood in my stool. I went to the Emergency room. Symptoms lasted for about 3 days. The doctor prescribed some medication for 7 days.
got Shingrix, lasted one year, my shingles returned/ suspected vaccination failure; my shingles returned; I have covid; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had battled with shingles outbreaks for 8 years).   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix vaccine last year and now the shingles symptoms had returned. At the time of reporting, the patient had Covid-19. The patient enquired if the vaccine can be taken multiple times. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
The week after the vaccination I was at my Rheumatoid Dr. with Guillain Barre Syndrome pain symptoms that didn't stop in the lower part of my L arm. She treated me with prednisone. I still have widespread pain from head to toe. Progressive headaches also started a week after vaccination and then on Nov 3rd my eyesight went blank; just gray, I couldn't blink it away. I was blinded. It lasted for 20 minutes and stayed longer in my L eye than my R. The blindness went away but the blurred vision started and till now my vision never gets clear. I've had so many eye and head exams. This is ongoing. Two weeks ago the joints in both hands started swelling. Now both hands hurt so bad that it hurts to hold the phone. I'm going to a new Rheumatoid Dr. tomorrow to look at my hands. I'm nauseated every day and take medication every day for it.
I became super dehydrated the night of my shot. My tongue and mouth were extremely dry and I kept drinking water but it didn?t really help. My whole right arm hurts, from shoulder to wrist, and I?m having vascular symptoms that I didn?t have with the other injections, such as red, burning hot hands, feet, and face, and I feel very hot but don?t have a fever. I?ve gotten symptoms like this before when extremely dehydrated so it could be from that, but there?s no reason for me to be this dried out?this is very unusual and the shot yesterday is the only new thing in my life. I really think it caused all this.
Herpes zoster eruption thoracolumbar region and wrapping about the left ribs to abdomen, severe back pain, itching rash
for Dose 1 of the COVID-19 vaccine. We called 911 & gave her 50mg Benadryl
Swelling and redness on left arm - 2 inches above elbow on inside of arm. Injection site showed some redness, but main reaction was 6 inches away from injection site.
Stiffening of both legs and swelling and redness. Started on the left leg and moved to the right went from the knees all the way to the ankles. His legs would get stiff and he would cry from the pain and couldn't walk to good.
ED Hospital on 12/02/2021 for cough with worsening SOB.   COVID-19 PCR was positive on 11/30.   Workup showed unremarkable CBC and CMP, inflammatory markers were elevated, high sensitivity troponin was elevated at 94 but remained stable, venous blood gases were unremarkable.     Patient was admitted for further management of acute hypoxic respiratory failure sec to COVID-19 pneumonia and he was started with Decadron/Remdesivir/ doxycycline/CPAP/4L NC O2- Patient was discharged 3 days later
After second dose of Pfizer COVID-19 vaccine, patient reported tingling sensation that started in her feet and traveled up her legs. Patient refused PO benadryl but took  Cetirizine 10 mg PO X 1. Patient was instructed to wait for 30 minutes of observation. At that time, the patient reported that the tingling sensation remained. The patient was offered to be taken to the emergency department, but decided to leave against medical advice.
Patient presented to the ED and was subsequently hospitalized for COVID-19 within 6 weeks of receiving COVID vaccination.
eyelid swollen; eye red; eyelid red; eyelid warm to touch; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch) and PYREXIA (fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch), PYREXIA (fever) and FATIGUE (tired). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, EYELID DISORDER (eyelid swollen), OCULAR HYPERAEMIA (eye red), ERYTHEMA OF EYELID (eyelid red), EYELID IRRITATION (eyelid warm to touch), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.
Your vaccine and 2 boosters made me very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "sick"; Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 Immunization, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Your vaccine and 2 boosters made me very sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (have an allergy on the local of the vaccine with some bubbles), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (My arm was bigger where I had the vaccine,have an allergy on the local of the vaccine with some bubbles) and VACCINATION SITE PAIN (hurting a lot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO MEDICAL HISTORY REPORTED.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (have an allergy on the local of the vaccine with some bubbles), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (My arm was bigger where I had the vaccine,have an allergy on the local of the vaccine with some bubbles) and VACCINATION SITE PAIN (hurting a lot). At the time of the report, ALLERGY TO VACCINE (have an allergy on the local of the vaccine with some bubbles), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (My arm was bigger where I had the vaccine,have an allergy on the local of the vaccine with some bubbles) and VACCINATION SITE PAIN (hurting a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Reporter did not allow further contact
High fever; This spontaneous case was received on 21-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04071) and concerned a patient of an unspecified age and gender.  The patient's medical history and concomitant medications were not reported.  On 20-Oct-2020, the patient was vaccinated with Fluad ((unknown if trivalent or quadrivalent) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration, dose and anatomical location: not reported) for protection against seasonal influenza. The batch number reported was not reported.  On the same day, the patient was vaccination with non-company co-suspect "multiple" other vaccines (dose, route of administration, anatomical location and indication: not reported). The batch number reported was not reported.  On unknown date in Oct-2020, the patient experienced high fever. The reporter referred patient to their physician for guidance.  At the time of initial reporting on 21-Oct-2020, the patient did not recover from the event.  The reporter did not provide causality assessment. The reporter stated that "it probably wasn't a good idea" to received "multiple" other vaccines at the same time.  The case was assessed as non-serious.  Case updated on 30-Oct-2020: Correction made to information received on 21-Oct-2020: Narrative amended with co-suspect vaccines, treatment measures and causality statement.  Company Comment: The event of 'pyrexia' was assessed as related to Fluad.; Sender's Comments: The event of 'pyrexia' was assessed as related to Fluad.
Lyme disease; Supply issue; This case was reported by a pharmacist via call center representative and described the occurrence of lyme disease in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced lyme disease (serious criteria hospitalization and GSK medically significant) and product supply issue. On an unknown date, the outcome of the lyme disease was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the lyme disease to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received the first dose of Shingrix and she had not yet received the second dose, partly due to the supply issue and partly due to hospitalized for about 15 days due to Lyme disease. Lot number was not available at the time of reporting. No further information was provided.  The reporter consented to follow up.
Body aches, sever headache, nausea/ vomiting, left arm pain with a lump where injection site is, stiff neck, feels like i am getting a cold, Sharp pain in left arm
Pentacel injection incorretly mixed, wrong diluent used. Patient exhibits no adverse signs. Vaccination to be re-administered
swelling, inc erythema & pain around inject site a day or two p/inject; pt was seen in office for this & given Medrol Dosepak;
Patient received the 2nd COVID vaccine (Pfizer lot#EW0182 08/2021) at 10:00AM. The vaccination was performed by RN, FNP. Following completed vaccination, RN, FNP noted the client's first dose was administered on 04/24/2021. The client received the 2nd dose of Pfizer 20 days following first dose instead of scheduled 21 days. Lead nurse, RN was notified. The client was provided education regarding early administration of Pfizer vaccine. The client was stable and left the clinic with a steady gait following 15 minute observation period.  Client was provided education regarding V Safe, signs and symptoms that would prompt EMS treatment, and to follow up with PMD via telephone on 05/15/21 by RN. Client voiced understanding of this and denied any signs and symptoms at the time.
Bivalent vaccines with their corresponding BUD dates; No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Bivalent vaccines with their corresponding BUD dates) and NO ADVERSE EVENT (No adverse event) in an 87-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent vaccines with their corresponding BUD dates) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Bivalent vaccines with their corresponding BUD dates) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Bivalent vaccines with their corresponding BUD dates).    No concomitant medication were reported. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date. Bivalent vaccines with their corresponding BUD dates and the interval period of administration. No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Significant follow up ; Patient information updated, vaccinations details updated On 24-Jan-2023: Live Non-significant follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
104 fever w/prolonged episode of intense crying; was excessively lethargic w/dec appetite the following day; tx APAP;
Febrile rxn (probable)-t103.3 ax, 4 days post vax; Also had sx of URI (fever devel 24 hrs p/DTP);
This 29 year old healthy male advised receipt of first injectable influenza vaccination on 3/7/2007 (unknown lot#) with TWINRIX, MMR and Td vaccinations and no reported adverse reactions. A review of his hard copy medical records noted complaints of sore throat and cough with diagnosis of URI on 3/9/2007 (day 2). He was treated with TYLENOL, SUDAFED, ROBITUSSIN DM/Codeine, rest, fluids, etc with full resolution of symptoms. On 11/7/2007 he received annual influenza vaccination with first FLUMIST (MedImmune 500497P). He advised he experienced a mild frontal headache and maybe some clear rhinorrhea self treating with MOTRIN and symptoms resolved within a few days. On 10/3/2008 he received FLUMIST (MedImmune 500554P) for annual influenza vaccination. Approximately 1-2 hours later a coworker advised his face appeared swollen. He recalls the right side of his face was swollen with no visual problems; he complained of a sore right nostril, runny nose, felt warm and had a headache 8-9/10 to frontal forehead area. He advised this headache felt twice as bad as the 2007 headache. He recalls the FLUMIST was inserted into only the right nostril and not both. He denied any chest pain, cough, shortness of breath, difficulty swallowing, tongue or swelling in his mouth, or hearing problems. He denied any egg allergy eating eggs daily without problems. He had no other immunizations with flu vaccinations. Providers documented 10/3/2008 mild photophobia, mild facial edema with swollen, red, shiny nares and clear rhinorrhea. He was diagnosed with a tension headache and treated with CLARITIN and BENADRYL with resolution of all symptoms within one week (per pt). Pt also reported the right nostril developed a sore inside his nose day after seeing doctor that also resolved. Providers submitted allergy to influenza vaccine 10/3/2008. Patient has not had any flu vaccinations since. 10/30/2013: patient received FLUZONE lot #UH908AB on without adverse reaction after skin/ID skin testing. Recommend no FLUMIST. Patient given diagnosis of angioedema, oral allergy syndrome (food reactions), and chronic rhinitis. MD note: Following receipt of FLUMIST vaccine in 2008. Given the temporal nature of his reaction following vaccination, it may be surmised that his facial swelling may have been associated with receipt of this vaccine. While his history does not strongly suggest an IgE-mediated process, it cannot be entirely ruled out on history alone. There is no standardized FLUMIST skin testing protocol. Therefore, he is tested today to injectable influenza vaccine both as a surrogate and to confirm the safe administration of future influenza prophylaxis (IM). His negative skin testing today does not suggest an IgE-mediated sensitization to the Seasonal Influenza vaccine or gelatin (which is found in other vaccines). The cause of his facial swelling temporally associated with his vaccination is unknown, but the risk of systemic reaction to subsequent vaccinations appears low.
Patient came to a vaccination clinic and received her first dose Moderna vaccine- she was ineligible for this vaccine due to her age (16 at time of vaccination).
Started with a headache. Took Tylenol for it. As soon as the Tylenol wore off I started to get body aches, I woke up and my symptoms were worse.