chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash started to cover my limbs, my buttocks, and my torso; It is terribly itchy.; Pfizer Bivalent; Dose Number: 1; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 at 15:00 as dose 1, single (Lot number: GH9702) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Dec2022 at 15:00, outcome "unknown", described as "Pfizer Bivalent; Dose Number: 1"; RASH PRURITIC (non-serious) with onset 24Dec2022 at 15:00, outcome "not recovered", described as "It is terribly itchy."; RASH (non-serious) with onset 24Dec2022 at 15:00, outcome "not recovered", described as "rash started to cover my limbs, my buttocks, and my torso". Therapeutic measures were not taken as a result of rash, rash pruritic.  Additional information: On 24Dec2022 a rash started to cover patient limbs, buttocks and torso. It was terribly itchy. No other vaccine in four weeks. No covid tested prior and post vaccination. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Reactive cellulitis (R) thigh and mild rxn (L) thigh. Azithro prophylactic ac tid-qid. Cool compresses x 48 hrs then low heat OK, ER if needed.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 23-NOV-2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # K022995, expiration date 22-JUL-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I am unsure of the dose number in the series or the manufacturer of the vaccine.  I am also no t sure which flu vaccine I received.      I have a 2 inch diameter welt on my arm where the vaccine was given and soreness to the area.
injected the wrong solution, they used saline vs sodium chloride/ mistakenly used sterile water for injection; injected the wrong solution, they used saline vs sodium chloride/ mistakenly used sterile water for injection; I have something in my body; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), via an unspecified route of administration on Jun2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she received the Pfizer COVID19 vaccine 1 week ago in Jun2021 and the vaccine site has contacted her to inform her they injected the wrong solution, they used saline vs sodium chloride (considered as wrong diluent used and poor quality vaccine administered). Caller was asking what is going to happen and how will this affect her health and felt a certain way, feel very unsafe. Mistakenly used sterile water for injection instead of sterile sodium chloride as the diluent for the Pfizer-BioNTech COVID-19 vaccine. After being advised to further consult with HCP as they may have ability to access additional information and provide better guidance for individual patient care she states that Pfizer was very secretive because do not provide more information. She further stated that due to no information being provided to the consumer this causes more panic mode. Now she had something in the body and she was calling Pfizer for help. She was trying to find the truth and protect her health. The outcome of events is unknown.  Information about batch/lot number has been requested.
PATIENT REPORTS THAT SHE NOTED REDNESS. SWELLING & ITCHING AROUND THE MOUTH FIRST & SPREAD ALL OVER HER FACE. SHE NOTED RASH ON HER LEGS. FEELS SWOLLEN BUT NO PROBLEM WITH BREATHING. 4-5 HOURS AFTER VACCINATIONS
Narrative: 84yr patient who presented to the ED on 9/14/2021 with a 2 ay history of congestion, runny nose, fatigue and cough, and productive of clear sputum following a recent travel history for a funeral (potential for exposure; dinner at a restaurant and funeral goers not wearing masks). (COVID related): In the ED was found to hypoxic to the low 80s with minimal movements. Was admitted to ICU for further care (on 2L oxygen via NC) given PMH acute hypoxic respiratory failure in the setting of COVID and known COPD & restrictive lung disease 2/2 resections due to metastatic colon cancer. Along with non-COVID clinical findings (see H&P note for non-COVID work up). Pertinent medical history: colon cancer metastatic to the lung s/p LUL and LLL wedge resection (2004), CAD s/p PCI RCA (2004), complete heart block s/p pacemaker (2018), CKD3, HTN, mixed obstructive (COPD) and restrictive lung disease, known thoracic aortic abdominal aneurysm. Received moderna vaccine x 2 (1/21 and 2/21). Hospitalized in  ICU for COVID PNA X 5 days; received dexamethasone and remdesivir (5 total doses) and was on supplemental oxygen (2L NC). discharge at day 5; stable.
low grade fever 99.5F; Soreness; Pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy), PAIN (Soreness) and PYREXIA (low grade fever 99.5F) in a 32-year-old female patient who received mRNA-1273 (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Jan-2021, the patient received dose of mRNA-1273 (Intramuscular) at an unspecified dose. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-Aug-2021. On 08-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 07-Jan-2021, the patient experienced PAIN (Soreness). On 10-Jan-2021, the patient experienced PYREXIA (low grade fever 99.5F). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy), PAIN (Soreness) and PYREXIA (low grade fever 99.5F) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with  associated AEs for this 32-year-old female. 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.    Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
It was reported post vaccine the pt developed a fever of 104.5F. She also developed an injection site reaction characterized by a 6.5" by 3.5" in area of redness and swelling. As of the date of this report the child is not much better. Follow up information received from the physician on 04/17/2001 indicated that the patient received the injection of Prevnar on 02/19/2001 and recovered.
I had a throat closer right after the shot. A few hours later, I got a severe headache that would not go away. My period cramps and flow got worst that lasted for about 4 months. My heart rate was high and would not go down. I went to the ER. They did EKG and said my heart was fine. I am still having evaluated heart rate.
Total body muscle and joint aching pain, fever 101.5, nausea, headache and back of neck pain, rapid heart rate, dizziness, weakness. Started about three hours after being administered. The worst of symptoms lasted approximately a day and a half. Was not completely recovered until almost three days later. I did not seek medical help and chose to self monitor.
pt exp heartburn 3 1/2hr p/vax, h/a 3 1/2hr p//vax, & swelling & rash on feet & lower legs 4hr p//vax lasting 24hr;upset stomach & diarrhea 4hr p/vax lasting 24hr;
Body aches started around 10pm 1/30/21, woke up with chills, fever, significant headache 0330 1/31/21; better by 6:30pm 1/31/21; all resolved  except aches am 2/1/21.
Ears itchy; Ears tingly; Hives on left side of body; Elevated heart rate; Elevated blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Ears itchy"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Ears tingly"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Hives on left side of body"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Elevated heart rate"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "Elevated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported as, within a few hours of getting the vaccine, her ears were itchy and tingly, in 48 hours, her arm hurt, and she broke out in hives on the left side of her body, the side she got the vaccine. Patient was not sure if it was her anxiety or a reaction to the vaccine, but she also had an elevated heart rate and high blood pressure. She consulted with her doctor, and he thought the hives on her left side, he believed to be an allergic reaction to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On left arm where client received Dtap 5 and polio 4, arm was red and swollen approx 7"x5". In the center of the redness was a large blister 1"x 1/2" with small blisters surrounding approx 3"x3".  Mother states he gets this reaction when he gets mosquito bites. Referred to physician.
Pt came to ED on 3/6/21 with allergic reaction symptoms (diaphoresis, facial swelling, nausea, vomiting, urticarial rash, tachycardia) due to 2nd dose of Moderna COVID-19 vaccination. This Moderna COVID-19 vaccine 2nd dose was received on 3/4/21 at Health Dept (Lot# 030A21A). On 3/6/21, "a 49y/o F with a past medical history of migraines and hypothyroidism who presents to the emergency department for syncope. Patient states she believes she is having an allergic reaction to the moderna COVID-19 vaccine. She received the vaccine two days ago and last night began to notice a few hives on her body. This morning she woke up with more hives diffusely throughout the body and swelling to the face and lips. She presented to  urgent care for this and while at the urgent care, she began to feel lightheaded, nauseated and had a syncopal episode while sitting in the chair. She denies hitting her head. After she woke up, she vomited after. Her mother states she was diaphoretic and pale during this episode. She was given benadryl and solumedrol at the urgent care. Paramedic was called and patient was brought in for evaluation of the syncopal episode. Patient denies any chest pain or difficulty breathing. She denies any throat swelling. She has had some diarrhea with this. No abdominal pain. She denies recent fevers or chills. She denies prior cardiac hx. No significant family history. Non-smoker.   Labs are notable for mildly elevated liver enzymes. D-dimer is elevated so CTA chest was obtained and is negative for PE. Patient was given solumedrol and benadryl prior to arrival. Symptoms improved during ED stay. No uvular swelling or oral involvement. Airway is patent. Patient advised to follow up with her PCP for re-evaluation and repeat labs. Rx for prednisone and pepcid. Continue benadryl."     Pt was given NS 1000 mL IV x1, diphenhydramine 25 mg IV x1, and famotidine 20 mg IV x1 while in SCH ED. Pt did already received diphenhydramine and methylprednisolone at the Urgent Care. Allergy added to patient chart for Covid-19 MRNA vaccine.  Then, on 3/7/21, patient did return to ED with continuing reaction (new upper lip swelling). Dr  noted: "Presentation c/w allergic reaction to Moderna vaccine. New upper lip swelling, but lower lip swelling and urticaria have resolved. No airway compromise or acute bronchospasm. Discussed option of switching from Benadryl to Zyrtec, if overly sedating. Continue Prednisone. Consider Pepcid twice daily. Discussed angioedema, with possibility of improvement without repeated exposure. Dose of Pepcid given in ED. Comfortable with plan to release."
Initial report received from a consumer on 18 June 2013. A 35 year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of YV VAX (lot number, route and anatomical site of vaccination was not reported) and received ADACEL (lot number, route and anatomical site of vaccination was not reported) both on 18 April 2013. The patient reported that on an unspecified date she experienced injection site reaction of a dime sized welt and that was mildly sore. The patient was not sure that which one cause the reaction, she believed "it to be the yellow fever just because the welt correlated with where that vaccine was injected." It approximately took 10 days for welt to completely fade. As of 18 June 2013, the outcome was recovered. List of documents held by the sender: None.
Redness and swelling on right upper arm, started on 1/26/21, no fever, no streaking
On dose number one: had chills and fevers of 101f for 2 days after the injection, managed with tylenol and rest. I also had a large lump on the site for over a week after the injection. It didnt hurt nor did it itch, no treatments.  On dose number two: i initially had fevers of 100-101 with some chills about one day after the vaccine.    Exactly one week and one day i woke up with watery diarrhea and abd cramping. I couldnt eat anything without feeling to need to run to the bathroom moments later. I then spiked a fever that evening that was nearly uncontrollable overnight at 103.9 but typenol and showers helped it come down. I figured a stomach bug but today on sunday 9th of may i woke up at 0830h w an itchy bump right upper arm and just assumed i may have been assaulted by a mosquito. But after a nap around 4pm to 6pm i woke up with hives on my bilat knees, as upper and lower, and some hives on my stomach as well. Itchy, different sized blotches of red scatter with no pattern all over my mentioned locations. I put on an antiitch lotion and took 50mg of otc benadryl and an hour later the itching has ceased, the meds are working and the hives are almost all gone.
Reporter is MD states would have required Dr visit if wasn't an MD. Vaccinated with Influenza developed slight soreness at site 6 hrs later. 24hrs later mild swelling, erythema 3" diameter & pruritis.
Patient presented 2 days after receiving vaccination with hard, raised, red  nodule at injection site. Nodule was warm to the touch. Discussed watching perimeter of inflamed tissue and to seek medical care if worsening. Pt will monitor, and treat nodule with cold compress and OTC antihistamine for itching.
Pfizer-BioNTech COVID-19 Vaccine EUA Headache without fever, 3 days, treated with acetaminophen
Patient took 2nd dose over 42 after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose over 42 after the 1st dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose over 42 after the 1st dose). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose over 42 after the 1st dose) had resolved.            No concomitant medications were reported. Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non-significant followup added to include AE contact information.
Little tenderness at injection sight (1-2 days); The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (04Aug2021), this case now contains all required information to considered valid.  This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in Arm at the age of 72 years old on 25Feb2021 08:00 (Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 Intramuscular administered in upper arm on 31Jan2021  at 09:15 am (Batch/Lot Number: EL9265; Expiration Date: 31Feb2021) at the age of 72 years old for COVID-19 immunisation. The patient experienced little tenderness at injection site (1-2 days) on an unspecified date. The patient stated that she is having open heart surgery and is concern about the Pfizer vaccine protection being compromised by the surgical procedure. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
That evening at bed time it became itchy, it became swollen and painful, burning sensation, it became enlarged. Itchy all the time. 5 days later went to the doctor and he prescribed an antibiotic, it began to help within 3 days after starting.
States arm was red and swollen 5/20/03 - given Benadryl at bedtime. Woke up 5/21/03 - had scratched - swollen and red upper right arm to elbow, few blisters and weepy, went to ER because had no regular MD. MD at ER saw pt. CBC done per ER and ER nurse states CBC OK and WBC 10.1. ER felt was cellulitis. Biaxin bid per ER - see ER MD or pediatrician tomorrow for evaluation. Ibuprofen per ER q 4hrs prn. Adverse reaction report filed.
On 10/16/2009-patient woke up with c/o not being able to move R leg, c/o pain. Patient's mother took patient to her doctor. Doc diagnosis patient with toxic synovotis
Severe abdominal cramping/discomfort followed by diarrhea, vomiting, chills, lethargy, muscle aches, fever of 102.5 with Tylenol.
1st booster about 6 months ago, one month later (around December) they got Covid; 1st booster about 6 months ago, one month later (around December) they got Covid; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "1st booster about 6 months ago, one month later (around December) they got Covid". Same patient received 2nd booster about a month ago, got covid again about a month after and it was their worst case of covid. They were sicker than they were the first time, hit harder than before. They were still ill, still having mild congestion issues.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Right-sided tongue swelling 13.5 hours after administration of second dose of the vaccine.  Resolving with benadryl and pepcid.
Patient received vaccine, was waiting for about 5 minutes in the waiting area when another customer yelled "He's passing out!". Upon running over, I noticed that the patients eyes rolled in the back of his head, his legs were straight out, and was making "groaning" noises. He was in this state for about 30 seconds. 9-1-1 was called immediately and patient was given water. When asked if he knew where he was, he stated "a pharmacy store for my COVID shot." He told me he remembers everything, saying he felt like he was in a dream during seizure. Questioned if he had ever had seizures before and he stated once when he was giving blood. No shortness of breath or hives noticed, therefore no EpiPen was administer. Ambulance arrived and asked similar questions that we had asked, and patient stated he was "just hot." He also seemed a bit yellow in color. Patient was able to stand up and walk to the ambulance with little to no help. All of this occurred in about 10 minutes total.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patient received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from the registered nurse regarding 1 day old female patient who on 06-JUL-2014 at 20:42 was vaccinated with improperly stored first dose of RECOMBIVAX HB (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, between 14-MAY-2014 and 21-JUL-2014, vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degrees. No symptoms reported. Additional information is not expected because all follow up information was received.
Right facial palsy following administration of GARDASIL. Followup will be 9 2-10.
The day after the vaccine on 11-12-2023, I experienced the following: headache, shivering, upset stomach. nauseous, feeling tired and weak. On Monday 11-13, I had stomach pain and diarrhea, very dry throat, trouble swallowing and lack of appetite.   Today 11-15 I am still feeling tired and weak and have intermittent diarrhea.
exp weakness & collapsed 2 days p/vax;pt adm to hosp & found to have E coli in blood;devel thrush & esophagitis & diff swallowing & a esophageal ulcer was suspected;HGB dec from 11.8 to 8.0;pt was losing blood;pt devel resp failure;BP
Moderna COVID-19 Vaccine EUA . Day of vaccine, soreness and swelling at the point of injection (upper left arm).  Headaches and low-grade fever (99.8 F to 99.0 F) continued for 6 days (current). Headaches were more intense in sensation with periodic sensitivity to sound in the first 24 hours.  Arm pain and swelling dissipated after approximately 36 hours.
Developed 3-4" diameter very hot red marking approximately 3" below injection site that persisted for several days despite use of hydrocortisone ointment as treatment. Almost gone at 6 days post injection.
this is one of two pt from this site to exp inconsolable crying for 3-4 hr after recv vax