chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis at her injection site; Arm was inflamed and red; Arm was sore and even under armpit; A lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Accident (She crushed her right arm in May 2020 with 18 screws in place.) in May 2020, Tumor (Stomach Tumor which was operated on at an unmentioned date.) in 2019 and Staphylococcal infection (Staph infection from the stomach tumor surgery.) in 2019.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit). The patient was treated with CEFIXIME (ANCEF O) ongoing from 02-Feb-2021 at a dose of 1 dosage form and CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included 2G IV Ancef with 2 doses total on 02FEB2021and 03FEB2021 and 10 days of Keflex 500mg/280mg. No concomitant medications were provided by reporter.
Information has been received from a physician concerning an 8 week old white female with no allergies or pertinent medical history who on 01-OCT-2008 was vaccinated po with a 2ml second dose of ROTATEQ.  There was no concomitant medication.  The physician reported that the patient immediately spit up what appeared to be entire dose of ROTATEQ as well as the milk just given.  The physician stated they could see the ROTATEQ in the milk.  Unspecified medical attention was given in the physician's office.  No laboratory diagnosis were done.  A product quality  complaint was not involved.  Follow up information was received on 21-OCT-2008.  The patient was reported to be 16 weeks old.  It was reported the patient experienced emesis on "08-OCT-2008".  The patient vomited up ROTATEQ and formula immediately after dose.  The patient recovered the same day.  Additional information has been requested. 12/03/08 This is in follow-up to report(s) previously submitted on 11/14/2008. In formation has been received from a physician concerning an 8 week old female with no allergies or pertinent medical history who on 01-OCT-2008 was vaccinated po with a 2 ml second dose of ROTATEQ. There was no concomitant medication. The physician reported that the patient immediately spit up what appeared to be the entire dose of ROTATEQ as well as the milk just given. The physician stated they could see the ROTATEQ in the milk. Unspecified medical attention was given in the physician's office. No laboratory diagnostics were done. A product quality complaint was not involved. Follow-up information was received on 21-OCT-2008. The patient was reported to be 16 weeks old. It was reported the patient experienced emesis on "08-OCT-2008". The patient vomited up ROTATEQ and formula immediately after dose. The patient recovered the same day. Additional information has been requested.
A few hrs. after administration of vaccine patient reported local pain and irritation.  Next day she came in and had local pain, swelling and redness.
PATIENTS REPORTS A VERY SORE ARM AND FLU=LIKE SYMPTOMS INITIALLY...MISSED THREE DAYS OF WORK. CONTINUES TO FEEL ILL AND LIGHT HEADED/DIZZY
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female with no medical history and no drug allergies, who on 26-NOV-2007 was vaccinated intramuscularly in the left arm with a 0.5mL first dose of GARDASIL (Lot# 658563/1063U). On 28-JAN-2008 the patient was vaccinated with a second dose of GARDASIL (Lot# 658563/1063U). There was no concomitant medication. Subsequently, the patient was pregnant. The patient believed her last menstrual period to be 20-NOV-2007 and her estimated delivery date was 26-AUG-2008. The patient was seen in the office. A urine pregnancy test was taken. No symptoms were reported. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow up information was received from the physician who reported that the patient's EDD was 11-AUG-2008. On an unspecified date the patient aborted her pregnancy as it was unwanted pregnancy. Upon internal review, pregnancy aborted was considered to be an other important medical event. Additional information is not expected.
Guillain-Barre syndrome with symptom appearance approx. 2 weeks after vaccine administration.  12/11/09, 12/14/09 and 12/15/09 - Hospital records and discharge summary received. Service dates 11/18/09 to 12/11/09. Assessment: Guillain-Barre Syndrome. Patient has been see 5 times during the past week. Patient c/o pain and burning all over. Weakness. Ears bulging and erythema. Oropharynx inflammed with enlarged tonsils and exudate. Neck stiff with lymphadenopathy. Headache. C/O Chest tightness, difficulty breathing. Discharged. Patient later presented with 5 day hx of diffuse body numbness and aches. Muscle spasms and pain. Post Vaccination Polyneuropathy. Readmitted 12/5/09. Significant weakness upper extremities bilateral. Tight feeling neck and shoulder areas. Constipation. Numbness lower extremities. Decreased reflexes upper extremities, increased reflexes at knees, upgoing toes. IVIG administration. Difficulty standing and walking. Walker use. Endurance decreased. Coordination impaired. Sensory changes. To rehabilitation 12/11/09.
(L) deltoid with swelling and erythema - (L) upper arm. Redness migrates down to elbow with assoc. pruritis.
Rec'd tetanus immun. 1/12/04. Large lump and swelling, red, warm to touch 2 1/2 by 3 1/2cm swelling going down arm to elbow.
Shortness of breath.  August 6th.  Admitted to the hospital August 9th.  CT confirmed unprovoked cluster of pulmonary embolisms in both lungs.
Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L042257, 17-AUG-2018; lot # L051123, 13-OCT-2018, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient received BNT162B2 in left leg; She had a rash over her body; high fever; excessive diarrhea; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 19-month-old female patient received BNT162b2 on 17Jul2022 as dose 2 (maroon cap), 0.2 ml single (Lot number: FT9142) at the age of 19 months, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), 0.2 ML SINGLE, Lot no: FT9142), administration date: 26Jun2022, when the patient was 18-month-old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset Jul2022, outcome "not recovered", described as "high fever"; RASH (medically significant) with onset Jul2022, outcome "not recovered", described as "She had a rash over her body"; DIARRHOEA (medically significant) with onset Jul2022, outcome "not recovered", described as "excessive diarrhea"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 17Jul2022, outcome "unknown", described as "patient received BNT162B2 in left leg". Therapeutic measures were not taken as a result of rash, pyrexia, diarrhoea. Parents did not know what to give her. Parents were going to take her to the hospital.
DOB Nov 9th 1994, received a Kinrix dose; Kinrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a Kinrix dose by mistake, which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient went t facility to be administered with Boostrix. The reporter consented to follow up.
Pt recvd 1st dose of Hep B on 7FEB92 & 10 days later exp lt upper quad pain, hematemesis & stomach cramps; On 20FEB92 exp a dec appetite & a bloated feeling; malaise, diarhea, flatulence, mild elevations of liver funct tests;
Total of 6 pts recvd Engerix-B & 2 days p/dose 3 pts had muscle aches 1 pt had local injection site reaction, 3 pts had nausea, treatment Excedrin otc tx; all 6 pts improved;
fever and fatigue  My daughter was told by her Primary Care Physician and the Pharmacist that my vaccine was not effective because I received the 2nd dose to soon.   Please note that the pharmacist advised her to report this information because this could have happened to others.    Also, the Dr. charged each of us $10.00 for each injection.
Regarding The Health on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
This case was reported by a healthcare professional and described the occurrence of injection site swollen in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to IMODIUM and allergy to KEFLEX. On 5 September 2012 the subject received 1st dose of FLULAVAL (.5 unknown, intramuscular, right arm). On an unspecified date in September 2012, at an unspecified time after vaccination with FLULAVAL, the subject experienced injection site swollen and injection site pain. The subject received FLULAVAL and complained to the healthcare professional about injection site being swollen, sore and painful. At the time of reporting the outcome of the injection site swollen and injection site pain were unspecified. The healthcare professional reported the office had up to 10 subjects or possibly more, with injection site swelling, soreness and pain, in some cases induration size of coin. Please see case A0996526A.
Dizzy 45 minutes after dose. Then left side of face swelled by jaw.  Pins and needles in sinus cavity and lymph nodes swelling
Mom called our office on 1/13/2020 describing patient with buckled legs, equilibrium off, dilated pupils, not blinking alot and just "acting odd". Mom was instructed to go ahead and bring patient to our office. At our office, patient was evaluated and diagnosed with Acute Cerebellar Ataxia and sent to Hospital Emergency Dept.
Pt felt light headed and distant post vaccine.  Pt assessed.  No other complaints or findings. Vitals obtained and repeated 10 minutes later. Stable. Pt discharged.
mom reported pt c/o lt upper arm from shoulder to elbow & around sides of arm warm to touch, hard, no fever but has been given APAP since last noc;
constant feelings that I'm dying; Brain fog; muscle fatigue; fatigue; tinnitus spikes; cold feet and hands; pins and needles in limbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 21 years, in right arm for covid-19 immunisation; influenza vaccine (FLU), on 23Feb2022 (Batch/Lot number: unknown), in left arm. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 28Dec2021, when the patient was 21-year-old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 01Mar2022, outcome "not recovered", described as "Brain fog"; FEELING COLD (non-serious) with onset 01Mar2022, outcome "not recovered", described as "cold feet and hands"; NEAR DEATH EXPERIENCE (medically significant) with onset 01Mar2022, outcome "not recovered", described as "constant feelings that I'm dying"; FATIGUE (non-serious) with onset 01Mar2022, outcome "not recovered"; MUSCLE FATIGUE (non-serious) with onset 01Mar2022, outcome "not recovered"; PARAESTHESIA (non-serious) with onset 01Mar2022, outcome "not recovered", described as "pins and needles in limbs"; TINNITUS (non-serious) with onset 01Mar2022, outcome "not recovered", described as "tinnitus spikes". The events "constant feelings that i'm dying", "brain fog", "muscle fatigue", "fatigue", "tinnitus spikes", "cold feet and hands" and "pins and needles in limbs" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of near death experience, feeling abnormal, muscle fatigue, fatigue, tinnitus, feeling cold, paraesthesia. Began taking Paxlovid within 12 hours of onset of Covid symptoms (fever, aches). Was symptom-free within 18 hours of first treatment. Completed five-day treatment with Paxlovid. Remained symptom-free for seven days after completing treatment, then redeveloped cold symptoms and tested strongly positive again. Cold symptoms subsided within about three days but still testing positive five days after return of symptoms. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sore throat, pale, rash over entire body, chest pain, diff swallowing;MD dx scarlet fever;
pt recv Comvax & hep B vax instead of peds HIB & hep B & p/vax pt exp unspecified reaction;pt sought unspecified medical tx; product confusion
Arm pain fromthe vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the injection site pain 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 received a dose of Shingrix vaccine and experienced arm pain. The patient asked should he/she put hot or cold compresses on vaccinated arm to relieve arm pain from the vaccine. The follow-up would not possible as no contact details were available.
A few days after November 8, 2018 after receiving the 1st of the two shots Shingrix i noticed a small circular patch of pink on my left calf...a month later it had spread a bit and at my annual derm appt. end of November 2018 i was put on a steroid cream for the spots...still spreading a few months later it had eventually spread to my entire body except face, and soles of feet ... after being diagnosed in April 2019 with a skin shave i've been diagnosed as Pitiriosis rosea and excema.  i was sent to phototherapy for almost 3 months which made everything worse...more things were coming out on my body...moles, and wart like things.  Something has spread to my hair and now i'm on a special shampoo and a night time oil.  Recently on 6 day prednisone pak, and the other day i had an appointment with clinic Dermotology .. i have another appt. with them in September.
Within 5 minutes after vaccination, Client had gotten up and stated he needed to use the restroom. As the client was walking towards the door, he began saying. " I feel like im going to pass out". Client was assisted to the chair. Cool rags were applied to the clients forehead. Client VS include BP 104/64 and HR 80. Client remained seated  for another 5-10 minutes. Client reported feeling better quickly after he sat down and was able to stand up and walk without  feeling lightheaded. Client was provided with crackers and juice. Client denied SOB, tightness in chest,or feeling like his tongue was swelling.  No cyanosis, or swelling of the face noted.  No rash noted.
Two days post vax, the pt developed an area 17 X 15 cm of the left thigh that was warm to the touch and swollen accompanied by a slight fever. Further information requested.
Fever of 101.8 (12-36 hours after vaccine) Body Aches and Chills (12-36 hours after vaccine) Sore lymph nodes (12-36 hours after vaccine) Arm soreness (onset 5 days after vaccine) Redness (onset 5 days after vaccine)
Information has been received from a nurse, for the Pregnancy Registry for GARDASIL vaccine (yeast), concerning a 15 year old female with no pertinent medical history or drug allergies who at the end of June 2008, was vaccinated with a dose of GARDASIL vaccine (yeast). The nurse did not have lot numbers or number of GARDASIL vaccine (yeast) doses received. There was no concomitant medication. It was reported the patient was pregnant. No adverse effect was reported. The patient sought unspecified medical attention via office visit. Additional information has been requested.
On the evening of the 25th of January,  I experienced the sudden onset of severe itching at the site of the vaccine.  The site eventually became red, raised, painful and hard and very warm to touch.  Overnight, the redness and discomfort increased.  I was seen by a nurse practitioner that morning. I was informed that it was a delayed reaction to the injection and to ice the area and take antihistamines and that it may take 3-5 days to subside.  I was told that I should still get the 2nd vaccination that is scheduled for February 15th.  Within the next 2 days, the redness diminished and the area was still slightly itchy and warm.
feel weak; feel "off"; Vaccination site pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feel weak), ILLNESS (feel "off"), HEADACHE (headache) and VACCINATION SITE PAIN (Vaccination site pain) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (headache). On 23-Apr-2021, the patient experienced ASTHENIA (feel weak), ILLNESS (feel "off") and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ASTHENIA (feel weak), ILLNESS (feel "off"), HEADACHE (headache) and VACCINATION SITE PAIN (Vaccination site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.
Patient developed facial flushing and hives during monitoring period. Patient was given 50mg Benedryl IM and patient and patient's O2 sats were monitored. Sats were maintained in normal range. Patient was monitored for an additional period of time until their symptoms subsided. Patient was with family who could continue monitoring them with the instructions to take them to an ED if symptoms recur.
feeling light headed, nausea, some coughing tightness in chest, some loose stool, lower back ache, weakness, lack of sleep the first night.  ate chicken noodle soup, tylenol PM, slept, drank white tea with peppermint tea, sucked, on Ricola drops and EmergenC drops
pt recv vax 6MAR96 & 2 hr later pt exp chills, malaise, SOB, & a local rxn;pt seen in ER & dx as a probable adverse rxn to vax;pt seen by MD w/SOB, chills, joint aching;
Mom stated that where the son had the shot at he had blood coming up through the pores. Went to the ER, the doctor stated that it was not blood and it happen again but went away.
Felt like throat was constricted; Increased heart rate; This is a spontaneous report received from a non-contactable consumer (patient). This 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on unspecified date in 2021 as dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that after the first vaccine he had an increased heart rate that came out of nowhere. He also felt like his throat was constricted both in 2021. He got it three weeks ago and his second dose was coming up. stated that he was trying to figure out if he should get the second shot or not due to the reaction he had after the first one. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.