chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kidney function worse; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced renal impairement.  The patient's medical history includes diagnosis of COVID-19 infection on an unknown date in October 2020, which required admission to the ICU for 5 days, and chronic kidney disease stage III.  On 27-Feb-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date in March 2021 at the patient's physical, his primary care physician informed him of worsening kidney function. Patient inquired if his health condition had any relation with the Moderna COVID-19 vaccine.   Action taken with mRNA-1273 in response to the events was reported as unknown.   The outcome of the event worse kidney function was considered unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rec'd 2 mos vaccines, including ROTATEQ 9/28/11. On 9/29/11 mother noticed blood streaks in stool in afternoon. Family Hx of Crohn's Disease.
at injection site little warm; at injection site have a bump; red at injection site; A spontaneous report ( United states) was received from a consumer concerning a 30 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ( vaccination site mass, vaccination site erythema, vaccination site warmth) lists.  The patient's medical history was not provided. No relevant concomitant medications were reported.  on 14/jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch : 011L20A ) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  Laboratory details not provided.  No treatment information is provided  action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was not reported.
cellulitis-redness, swelling, area 8 1/2cm x 14cm immunization given on 14APR99 reaction 15APR99;
Noticed swelling, itchiness, redness as of 6/27/14 at night. Improved within weekend. Measured in office 35x45 mm.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Mild
Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021  In a retrospective chart review that was conducted in 2 HIV primary care clinics. Patient, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA undetectable, CD 4 count 214 cells/uL, CD 4 14%, positive for anti-HBc and negative HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This spontaneous report was received from a licensed practical nurse and refers to a 12 year old male patient. The patient has had no significant intercurrent illnesses over the past couple of months. Patient has myopia and currently wore glasses. The patient was pleasant, alert and active. Neurological examination was normal with CNs 2-12 intact, normal sensation and strength, motor strength-5/5 upper and lower extremities. The patient's medical history included heart surgery at the age of 5. The patient was allergic to ketamine (developed rash). The patient had one chicken pox vaccination on an unspecified date. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) 0.5, lot number L008273.on the left deltoid. Concomitant medications were not reported. The outcome of the incorrect product storage was not known. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
20min p/vax pt became irritable w/cough, digging @ ears, congested eyes & spitting;quickly devel hives on trunk & back;no wheezing;pt sent to ER;
Pt.'s mother states that after receiving the 2nd dose of Phizer vaccine the Pt. collapsed 05/26/2021 and passed away. Currently waiting for Autopsy results.
Left (non-dominant) wrist pain increasing over a week. Occurred after sustaining no injury. Visited ER after not being able to use wrist because of severe pain for around 12 hours. Diagnosed as tenosynovitis with an unknown cause. Put in a splint for 1-2 weeks, following up with primary care tomorrow.
Immediate swelling of (L) eyelid progressing to (L) side of nose and (L) side of lip. Mom applied ice on eye. The swelling was gone in the next morning.
Information has been received from "mid to late fifties" year old male who, "in early November 2008", on approximately 01-NOV-2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included influenza virus vaccine (unspecified). "Within 12 hours of receiving the vaccine", the patient experienced soreness, redness and swelling of his entire upper arm. The patient reported that he normally got the PNEUMOVAX vaccine every five years because he had a history of a heart condition. The patient reported that his entire upper arm was warm to touch and the symptoms he experienced had started initially at the injection site. The patient reported that he had trouble in putting on his shirt because his arm was so swollen and sore. The patient returned to his physician to seek medical attention. At the time of this report, 03-DEC-2008, the patient was fine. Follow-up information was received from a physician who stated that the 61 year old male patient on 28-OCT-2008 was vaccinated with PNEUMOVAX vaccine in his left arm (LOT# 658074/0803U). Twenty four hours after vaccination on 29-OCT-2008 (also reported as 29-OCT-2009) the injection site was swollen, tender, and redness. Then forty-eight hours, his left forearm swollen twice the size and had shoulder and joint pain. The patient called office, the physician told him to use heat and ice on site and Motrin for pain. 5-7 days later, the patient was recovered from the adverse events. The patient did not call back. No further information is available.
pt recv vax 14OCT98 & 24hr later devel redness @ the inj site;
FLUE LIKE SYMPTOMS  STARTIED ON THE FIRST DAY OF THE INJECTION.  THE SECOND NIGHT I WAS ENVELOPED IN SWEAT AS I SLEPT, BUT NO ACHING BONES.  THIS HAS  OCCURRED FOR TWO  NIGHTS.
had covid before/her previous covid vaccines were of Pfizer's; had covid before/her previous covid vaccines were of Pfizer's; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "had covid before/her previous covid vaccines were of Pfizer's". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was currently taking Xeljanz and was thinking of getting the flu shot and the bivalent covid vaccine. She mentioned that she had covid before and was taking Paxlovid for it. She added that she took her last dose of Paxlovid in the morning of 30Jul2022. She also added that her previous covid vaccines were of (withheld). She is wondering how long does she need to wait to get the bivalent vaccine after having covid. Caller also asked as follow-up, since she took Paxlovid during her covid infection, she wanted to know if how long she should also wait before getting the bivalent vaccine if her last dose was on 30Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient received a 0.25ml booster shot, was supposed to receive a 0.5ml Additional dose, due to being immunocompromised. patient will return to get the correct shot.
2 days after the Moderna shot I awoke with medium sized pimples, very itchy, tipped with white, mostly on right upper body, mostly in hollow under clavicle and on midriff below breast.  There were also random sites: on right leg, on left arm, on belly.  They kept appearing for about a week and even now another will pop out.  I had myself checked out at the above clinic, with a triage practitioner.  I was concerned that perhaps it was shingles, but she advised that it was not.  She thought it could be a reaction to the Moderna shot
About 8 days after getting the vaccine, the injection site started to itch and swell up. The area swelled up is about 2 inches long, about 1.5 inches across.  I've used hydrocortisone on it. It does not look as red as it initially did and not itching as much, but it has not gone away.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a elderly male patient who received Influenza vaccine Quadrivalent. Concomitant products included PNEUMOVAX. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, 14 days after receiving Influenza vaccine Quadrivalent, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that, the patient received a flu vaccine a few years ago. The patient also received another vaccine, PNEUMOVAX, on the same day with the flu vaccine. The patient developed Guillain Barre Syndrome about 2-3 weeks after receiving the vaccine. The healthcare professional stated that the vaccine was administered at another facility so, the brand of influenza vaccine administered was unknown. The reporter also stated that, the patient reports the hospitalized for a period of 4 days in Intensive care unit during this event. No further information was reported regarding the event.
This spontaneous report was received from a healthcare worker refers to a patient unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 01-AUG-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.feeling faint.   Assessment : Time of assessment 1202. Alert and oriented. Patient stated she felt dizzy and faint.  Patient vital signs taken, patient given water and snack.     Actions taken:  Vitals sign taken 1202- BP 143/72, HR 74 oxygen level 99%.  1210- BP 150/75, HR 78 oxygen level 100%.     There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 15 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.  Instructed to follow-up with PCP if dizziness reoccurred.  Patient discharged home at 1228.
Non-pruritic diffuse blanched rash of whole body, nausea, paresthesia (burning sensation), gradually worsening within a few hours of injection. Seen next day. Benadryl and ibuprofen. Pending recovery.
I have a severe Shingle outbreak that impacted my right eye as well. This happened on 4/6/32. I had taken the Pfizer Covid Vaccine on 3/20. Now I have seen an article saying Herpes Infection could be a side effect of Pfizer Covid Vaccine
Vaccines given 7/10/03, wisdom teeth (4) out 7/17/03 with Versed, phentenol, dumethin and droperidol given. Felt OK until 7/23/03. Felt dizzy, falling, unstable, vision- complained of "things falling in and out". Intermittent spells of dizziness continued. On 7/28/03 complained of headache-Imitrex didn't relieve. On 7/29/30 complained of "feeling drunk", dizzy-eyes "jumpy". Today 7/30/03 complained of continued symptoms. Appt to see private physician 7/30/03.
Rebound of COVID-19 symptoms and positive antigen test on day 12; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of COVID-19 symptoms and positive antigen test on day 12) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient did not have any relevant medical history.  Concurrent medical conditions included Penicillin allergy and Sulfonamide allergy (Sulfa).   On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of COVID-19 symptoms and positive antigen test on day 12). At the time of the report, COVID-19 (Rebound of COVID-19 symptoms and positive antigen test on day 12) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) positive antigen test.          It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient tested positive for COVID-19, 6 days after finishing Paxlovid five day treatment. The patient did not receive any treatment. Company comment: This spontaneous case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 170 days after receiving the third dose of mRNA-1273 Vaccine. There was no information regarding the initial two doses. On May 12, 2022, SARS-CoV-2 test was done which revealed a positive result. It was reported that patient tested positive for COVID-19 6 days after finishing Paxlovid five-day treatment. Details of clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 170 days after receiving the third dose of mRNA-1273 Vaccine. There was no information regarding the initial two doses. On May 12, 2022, SARS-CoV-2 test was done which revealed a positive result. It was reported that patient tested positive for COVID-19 6 days after finishing Paxlovid five-day treatment. Details of clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
pt recv vax 29APR94 & 30APR94 pt devel an urticarial rash over trunk & legs; @ the time of the report, the rash persisted; No further details were provided;
3x3 induration with 2x2 redness in center with small bumps and tenderness.
Tingling beginning at thumb and pointer finger, progress to forearm and upper arm over 3 days. Swelling began near elbow, redness and pain followed and immobility. Visited ER on 2/3/21 and diagnosed with superficial thrombophlebitis
Hives on Arms \ Hives on Legs; loss of taste; loss of smell; metallic taste; headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on Arms \ Hives on Legs), AGEUSIA (loss of taste), ANOSMIA (loss of smell), DYSGEUSIA (metallic taste) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20H) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced URTICARIA (Hives on Arms \ Hives on Legs), AGEUSIA (loss of taste), ANOSMIA (loss of smell), DYSGEUSIA (metallic taste) and HEADACHE (headache). On 20-Mar-2021, URTICARIA (Hives on Arms \ Hives on Legs) had resolved. At the time of the report, AGEUSIA (loss of taste), ANOSMIA (loss of smell), DYSGEUSIA (metallic taste) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment information was provided   This case was linked to MOD-2021-265646 (Patient Link).
Lightheaded and nausea within 5 minutes of vaccination. Provided hydration and something to eat. After 15 minutes she complained of difficulty breathing. Located NP and patient HR, breathing, and oxygenation was found to be within normal limits. After 30 minutes, patient was feeling well enough to go home with her mother.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 04Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "interchange of vaccine products" (unspecified if ongoing), notes: Dose 1 &2 - Moderna, Dose 3 &4 Booster- PFizer. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Myalgia, NauseaVomiting, Fatigue, Chills
This is a 88y.o. female  The patient has a past medical history of congestive heart failure anemia CKD diabetes mellitus hypertension the patient comes in secondary shortness of breath has been experiencing intermittent shortness of breath from almost greater than 2 months the patient has been getting worse with cough nonproductive sputum the patient has any chest pain.  Patient was also recently treated for underlying pneumonia at hospital.  In the ED the patient's labs were obtained the patient's glucose 264 troponin 0.04 troponin  On further repeat was 0.10 patient leukocytosis was noted.  Patient's chest x-ray did not show any acute cardiopulmonary process EKG shows tachycardia patient was given DuoNebs aspirin hydralazine labetalol Solu-Medrol and placed on heparin infusion
p/vax pt exp chickenpox, a fever of 102, bad h/a & stomachache & vomiting;
This healthy 27 year old received her 2nd AVA (BIOTHRAX lot # FAV273) and 2nd JEV (IXIARO lot# JEV09m40f) on 6/10/2011 after completing required forms marking no to question 5 on pregnancy. The next day she felt ill attributing complaints of a headache and nausea to recent vaccinations. However, she uses NUVARING for birth control and reinserted ring one week late while remaining sexually active. Her LMP was 5/3/11. A home pregnancy test was positive on 6/11/2011. She advised immunization and medical clinic of this new pregnancy with bHCG 6/13/2011 also showing positive. 6/14/2011 SM presented to clinic to review concerns on pregnancy following receipt of AVA and JEV vaccines.
body aches; chills; fatigue; After every vaccines he experienced pain at the injection site for 12 hours; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "After every vaccines he experienced pain at the injection site for 12 hours"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  Additional information: Patient received multiple Pfizer-BioNTech Covid-19 vaccines as part of the recommended series. After every vaccines he experienced pain at the injection site for 12 hours, chills, body aches, and fatigue.Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 2nd of 10 cases. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that the injection hurt a lot on an unspecified date with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug/event, different patient.