chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report received from a nurse on 06-OCT-2010 (report via license partner, 1010USA00658). A female patient received AFLURIA (batch number 10749111A, expiry 29-JUN-2011) for flu vaccination on 04-OCT-2010. The 0.5 mL dose was administered in the right deltoid intra-muscularly. It is unknown if the patient had a relevant history or was taking concomitant medication. On 04-OCT-2010, approximately 8-10 hours after AFLURIA administration, the patient broke out with a systemic rash and experienced swelling in her hands and face. The patient went to her local emergency room and was treated with unspecified antihistamines which failed to clear up the rash and swelling. The patient sought medical attention. On 06-OCT-2010, the patient's physician started her on steroids for treatment. No further information provided. The patient outcome was not recovered at the time of reporting. This case was considered serious due to intervention to prevent serious criteria. The company considered events possible to AFLURIA administration due to short time to onset of events. Information derived from this AE report does not change the current safety profile of the product.
Vaccine on the 30th and started feeling sick 2-3 days later. Patient states nausea, muscle pain, stomach pain, head hurt, standing up made him dizzy. No fevers. Patient presented to ED with weakness, gait difficulty, dizziness and nausea. Patient states his left hand is so weak he is unable to grip anything including a pen due to symptoms. Patient had extensive workup in hospital and was dx with ASEPTIC MENNIGITISwhich they feel could be related to flu vaccine as patient developed symptoms after having vaccine.XrayChest-No acute cardiopulmonary abnormally identified. CT Angiogram head, CT venogram head-Unremarkable.CT Angiogram Head, CT angiogram neck-No acute intracranial vascular occlusion or significant stenosis.MRI brain- There is no acute infarct in the brain.Suspect infection or inflammatory process such as herpex complex encephalitis, venous thrombosis,or vasculitis.TEE-NO cardiac sorce of embolus  identified. WBC-11.5.Patienthospitalized on 10/9/2020-10/13/2020 for aseptic meningitis possible related to recent flu vaccine. He was seen by neurology and infectious disease specialist.Patient reports decreased strength in left hand, reports loss spatial awareness on the left side reports he bumps into objects/furniture. Walking  isslower.Reports loss of sense of taste. His son reports he also has trouble with organization and complex reasoning.Pt seeing neurology and PT at this point.
This started with feeling sick and a medium case of the chills and then all of a sudden I?ll get warm, almost hot, ( my first dose I had the chills in a very BAD way), muscle pain, tiredness. The long adverse effects are chills and eventually ill get warm, and muscle pain.
About 25 minutes after receiving her dose her throat began to feel like it was closing almost as if she were being choked. Her nose swelled shut and her neck and face became very red. This lasted until about 11pm. She took benadryl and drank a lot of water.
Patient phoned on 4/13/18 at 12:35 pm and stated, "I received the PREVNAR 13 vaccine on 4/10/18 around 5:30 or 6 pm and started on Wednesday morning, 4/11/18, around 10 am with chills, flushing, severe headache pain level 7, severe joint/muscle pain, swollen face, couldn't raise the arm that the vaccine was given in, arm was very painful, and I had a 4 x 6 inch rectangular swollen reddened tricep area. I did not have a thermometer to check my temperature. I had no difficulty breathing. I took ibuprofen, but it didn't help much with the inflammation or pain." Patient was offered appointment for evaluation. Patient declined. Patient stated, "I am feeling better and only have the slight puffiness in my face. All other symptoms have resolved." Informed patient that I will report her adverse reactions to VAERS.
Narrative:  COVID infections following completion of COVID vaccine series 12/31/20 COVID vaccine dose #1 01/21/21 COVID vaccine dose #2 07/22/21 Pt called office reporting COVID POSITIVE test from place, requesting test through agency; reports slight cough but no fever or other symptoms; COVID POSITIVE 07/23/21 Pt reports cough, runny nose but is stable; rx given for DM/guaifenesin 07/26/21 Pt is stable and improving
Wrong vaccine given. Patient needed a dose for primary series, which was not available in office at the time of her visit.
An area 25 mm by 50 mm is noted on back of left arm, red and indurated. Surface slightly raised approximately 2-3 mm.
C/O feeling hot and "shaky". TX: had student sit for 30 min to observe for further s/s. Stated "Felt a little better" returned to class - no hives, itching, SOA n/v.
Patient received expired dose of deptacel vaccine/No AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA046254, 2020SA046245 and 2020SA046250. (same reporter)  This case involves a 15-month-old female patient (patient: 02) who was vaccinated with 0.5 ml expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366AA and expiry date: 07-Feb-2020) via intramuscular route in the left thigh on 14-Feb-2020 for prophylactic vaccination (Expired product administered ).  Medical history, medical treatment, vaccination and family history were not provided.  On 14-Feb-2020, the patient received concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) (fourth dose).  It was case of actual medication error due to Expired vaccine used.  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 holders 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.
Sudden (moderate) hearing loss left ear; tinnitus; fullness in ear; periodic vertigo
Lt thigh swollen fr knee up very red & hot to touch; Crying/screaming x 1hr w/occas dozing; Doesn't want to be comforted; Low grade temp;
Dizziness; High blood pressure episode; headache; she had COVID; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERTENSION (High blood pressure episode), COVID-19 (she had COVID) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for Blood pressure high.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (she had COVID). On an unknown date, the patient experienced DIZZINESS (Dizziness), HYPERTENSION (High blood pressure episode) and HEADACHE (headache). At the time of the report, DIZZINESS (Dizziness), HYPERTENSION (High blood pressure episode), COVID-19 (she had COVID) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Reporter wanted to know if patient can take the booster dose before the second dose because the booster is only half a dose and she doesn´t want to feel those symptoms again.  Patient has not yet recievd the second dose of vaccine.  This case concerns a 71-year-old, female patient with no reported medical history, who experienced the unexpected, non- serious and AESI event of COVID-19. The event occurred approximately 6 months after first dose of Spikevax. The rechallenge is not applicable, as the outcome of the event is unknown. The benefit risk relationship of vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 71-year-old, female patient with no reported medical history, who experienced the unexpected, non- serious and AESI event of COVID-19. The event occurred approximately 6 months after first dose of Spikevax. The rechallenge is not applicable, as the outcome of the event is unknown. The benefit risk relationship of vaccine is not affected by this report.
Employee complained of itchyness, blurry vision, feeling dizzy 10  minutes after vaccine was injected, and then complained she feels burning sensation in her throat. Denies difficlty of breathing, headache.  Transported to ED and treated with Benadryl. Took Benadryl for 3 days.  Headaches lasted about 1wk and took ibuprofen.   Employee reported she had hives for 3 days after her 1st dose. Took Benadryl. This wasn't previously reported to us.
Prominent hematoma in her hand, fingers, in her palm, in between fingers and on thumb. Few days later she developed it in her pinky; Severe pain; This is a spontaneous report from a contactable physician for herself . A 47-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date (after the dose), the patient developed prominent hematoma in her hand, fingers, in her palm, in between fingers and on thumb. Few days later she developed it in her pinky for which the patient needed to go to emergency room due to severe pain. It was reported that patient developed hematoma after the vaccine only and did not had this before. The reporter considered the event as non-serious. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pneumonia with blood clots in right lung, and suddenly I was told I had a new autoimmune disease when I was concerned the vax caused this as I was fine before, just a bit of allergies going on due to my pets.
Limping with a stiff leg Fever of 101 Loss of appetite Loss of sleep Irritable and emotional Nonsensical and confused
Injection site was warm; Injection site was pink; Injection site hardening; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site was warm), INJECTION SITE DISCOLOURATION (Injection site was pink) and INJECTION SITE INDURATION (Injection site hardening) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced INJECTION SITE WARMTH (Injection site was warm), INJECTION SITE DISCOLOURATION (Injection site was pink) and INJECTION SITE INDURATION (Injection site hardening). At the time of the report, INJECTION SITE WARMTH (Injection site was warm), INJECTION SITE DISCOLOURATION (Injection site was pink) and INJECTION SITE INDURATION (Injection site hardening) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient explained that she would experience injection site warmth, induration and discoloration immediately after receiving tetanus shot.
Around noon the day following the shot, I began to not feel good (a little achy) and when my seatbelt strap touched my arm it was noticeable painful. I finished my errands and went home. In the next few hours, the sight became more painful.  I couldn't touch it. When I looked, the site around the injection was red, hot, and beginning to swell. It spread out and was about as big as my hand. By 3:00 pm that same day, I felt feverish.  I had a 100.9.  My body ached, I was very tired, and I had a sight headache. The fever and body aches lasted 24 hours. The injection site stayed inflamed, red & swollen and painful for over a week.  The pain and swelling subsided gradually that week, but the redness stayed for about another week. I had Covid in December 2020 and my fever was only low-grade never getting about 100.2. So my fever with the shot (for a 24 hour period)  was higher than when I actually had Covid.
Information has been received from a pharmacy student concerning a patient who on approximately Oct 14, 2002, about one week ago, was vaccinated with pneumococcal vaccine 23 polyvalent. On approximately Oct 14, 2002, the patient developed anaphylaxis and was hospitalized. Additional information has been requested.
Left arm Cellulitis with fever, headache and bodyaches. Patient forgot her Moderna vaccine info card at home
Limitation of movement; extreme soreness above the injection site (around the shoulder joint); soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Limitation of movement), INJECTION SITE PAIN (soreness at the injection site) and ARTHRALGIA (extreme soreness above the injection site (around the shoulder joint)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J200A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection site). In February 2021, the patient experienced HYPOKINESIA (Limitation of movement) and ARTHRALGIA (extreme soreness above the injection site (around the shoulder joint)). At the time of the report, HYPOKINESIA (Limitation of movement), INJECTION SITE PAIN (soreness at the injection site) and ARTHRALGIA (extreme soreness above the injection site (around the shoulder joint)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
slurred speech; Memory loss; loss of cognitive functions; increased appetite; nausea; headaches; weight gain; unable to stay focused; shortness of breath / difficulty breathing; chest pain near heart; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162) unknown dose via an unspecified route of administration in deltoid left on 15Apr2021 at 01:45 (at the age 29 years) as single dose for COVID-19 immunization. Medical history included depression. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination: Allergy medicine, ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 at 16:00, the patient experienced memory loss, loss of cognitive functions, increased appetite, nausea, slurred speech, headaches, weight gain, unable to stay focused, shortness of breath, difficulty breathing, chest pain near heart. Outcome of the events was recovered with sequelae.  No follow up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse refers to a 49 year old female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 11-JAN-2019, the patient was vaccinated with VAQTA 50/1.0 U/ml, first dose, intramuscular, lot number R027987 and expiration date 09-AUG-2019 (dosage schedule, anatomical location, were not reported). On 11-FEB-2019, the patient was vaccinated with VAQTA 50/1.0 U/ml,  first dose, intramuscular, lot number R031045 and expiration date 18-NOV-2019 (dosage schedule, anatomical location, were not reported). On the same day, the patient received a inappropriate schedule of vaccine administered. No adverse events were reported. The outcome of inappropriate schedule of product administration and no adverse event were unknown.
Received MMRV (Merck Lot L009210) on 5/9/2016 to left thigh and Hep A (SK Lot# X22P4) to right thigh. Mom advised day of vaccination there were 3 dots to his right leg (providers documented as 2 lesions/wheal). These dots were diagnosed as resembling insect bites vs urticaria and was to observe. (Pictures taken). The next day, 5/10/2016, mom advised there were some vesicle like red spots to both vaccine sites that were red but she took to daycare. Daycare called to report that this rash had spread to both legs, abdomen and face. Mom brought child to ER (workplace) where providers diagnosed as urticarial rash. Mom was treating with oral BENADRYL which did reduce the rash significantly prior to exam. The next day 5/11/2016 mom said rash gone but now had splotchy redness to left leg vaccine site (MMRV) that progressed up to his abdomen. This lasted less than 12 hours and resolved. Mom used BENADRYL every 6 hours x 2 days without return of reaction.
Sore arm; Did not feel 100 percent but felt ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9263) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1998 (ongoing), notes: MS; "Immunosupressed" (unspecified if ongoing), notes: has an underlying condition and is immune suppressed. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; MALAISE (non-serious), outcome "unknown", described as "Did not feel 100 percent but felt ok".  Additional information: Indication as Reported by the Primary Source: has an underlying condition and was immune suppressed. She was concerned about health information and how this will be shared and was calling about the newest Pfizer bivalent vaccine and had a very severe reaction to it and ended up going to the emergency room twice and has been diagnosed with acute pericarditis with fluid around her heart and has no other cause of that and it was directly related to the timing of when she got the vaccine. She knows that has been reported in young men and teenage boys but it has not been reported in her cohorts so she called her pharmacy and they directed her to call Pfizer. All the vaccines she received were Pfizer and the 1st dose was administered on 25Jan2021 with EL9263 and her card has no expiry dates or NDC to provide; For the prior dose of the Pfizer vaccine she had on 14Mar2022, all other doses prior to that one she had the typical sore arm for 48 hours and did not feel 100 percent but felt ok and had nothing major Indication for the Pfizer Vaccine: she has an underlying condition and was immune suppressed and every time she has an opportunity to get this she has been advised she should have it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300215077 Same product, patient, different event, different dose;US-PFIZER INC-202300215226 Same product, patient, same event, different dose;US-PFIZER INC-202300215227 Same product, patient, same event, different dose;US-PFIZER INC-202300214232 Same product, patient, different event, different dose;
Mom states pt began to run fever @ 5PM states gave APAP but by 12noon 30MAY92 took pt to MD w/fever of 103, diarrhea, crying & would not eat;
No adverse event; 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 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (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 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (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 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (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 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (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 30day beyond use date.).    No concomitant medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022. No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Full body rash and rash is worse around  elbow, hip and knees. Swelling of areas where rash is worse   started to appear a few days after second dose
patient is done with the first dose and tested positive after; patient is done with the first dose and tested positive after; This is a spontaneous report from a Pfizer-sponsored program, by a contactable physician.   A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was done with the first dose and tested positive after on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient is about to be done with quarantine and asking if it's okay to take the second dose.  Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.