chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I ended up with an infection in the glands in my neck and throat. Caused edema and cellulitis ended up in the hospital for an overnight of IV antibiotics, steroids' and pain meds because my throat was closing. The swelling was restricting my airway. I was instructed by my MD to file this report.
"bright red belly button"; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA ("bright red belly button") in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA ("bright red belly button"). At the time of the report, ERYTHEMA ("bright red belly button") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Breakthrough case after fully vaccinated/Boosted, C/O sore throat, runny nose, sneezing, and head congestion
Local Symptoms: itching. General symptoms: chills, fever, joint pains, fatigue, nausea, vomiting, diarrhea. Narrative:
Pt recvd 3 doses of Engerix-B in 1989 & titer was checked post exposure in NOV91 found to be non responsive; tx will revax or give booster dose;
Patient received flu vaccine went down to pharmacy had a syncopal event. Mom reported it was brief about a second or two pt jerked and vomited. Upon questioning mom she reported patient's sister had seizure similar to this after flu vaccine. Vitals taken within normal range.
Information has been received from a licensed practical nurse concerning an 18 month old female with no known drug allergies who on 04/05/2001 was vaccinated with varicella vaccine. There was no concomitant medicaiton. On 04/25/2001, the pt returned to the office with a vesicular rash of 5-10 lesions on her trunk and face, for which medical attention was sought. Additional info has been requested.
Initial report received from a health care professional on 18 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 10073804) on 15 Dec 2009. The patient experienced bad headache after 1 hour and felt dizzy with vision problems after 5 hours of vaccination on 15 Dec 2009. The events resolved on 16 Dec 2009. Outcome of the events was reported as complete recovery.
Chills, fever, headache, muscle pain, nausea, dizziness, vomiting, teeth chattering.
I tested positive for COVID-19; I tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 17Dec2020 19:45 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient tested positive for COVID-19 on 03Jan2021. Outcome of event was recovering. Patient has not been diagnosed with COVID-19 prior to vaccination.
Initial misuse report received from a healthcare professional on 26 September 2013. The case was received on 21 March 2014 at agency. A 0.5 ml dose of FLUZONE was given to a pediatric patient. No adverse event was reported. List of documents held by sender: none.
Adverse events included facial swelling, extreme fatigue, headache, nausea, vomiting, sore throat, rash, "creaky" bones, diarrhea, loss of appetite, leg pain, stomach pain (described as a "stinging" pain), generally not feeling well, congestion, wheezing, coughing, visual disturbance, single incidence of SVT (racing heart).  Symptoms progressed and worsened over a 4-month time span.  Symptoms were inconsistent on a daily bases, and persisted over a 4-month timeframe.  Patient missed over 40 days of school due to severe and ongoing symptoms.  Course of illness began with facial swelling, progressed to flu-like illness including diarrhea, then to visual disturbance in Dec 2019, and incidence of racing heart occurred in Feb 2019.  Patient ended up in ER on March 1, 2019 where tests were run, mild UTI and Wolfe-Parkinson-White were detected and diagnosed.
Pt had 2 episodes of emesis after receiving the vaccine. Pt then developed fever, cough, runny nose, and malaise. Symptoms are improving with Nyquil.
Severe H/A left side, nausea, tachycardia, SOB, diaphoresis. Symptoms resolved within hour without treatment. Declined ED visit.
Patient received  vaccine first dose. Patient is 17 years old and this has not approved for this age group to receive this vaccine. Patient's mom was informed error of administration and was scheduled to have a telehealth appointment with a pediatrician to discuss receiving the second dose. Patient had no adverse reactions with the vaccine she received.
pharmacist administered 1.0 ml dose instead of 0.5 ml dose.  pt  & clinic notified immediately upon discovery of error.  pt reported no pain at injection site or other issues at the time (about 2 hrs after immunization).   CDC guidance document says pt may experience more pronounced post-immunization s/sx and the 2nd dose may be skipped unless the pt & dr feel it is in the pts best interest to administer.
Sudden abdominal pain, shortness of breath on day after vaccine was administered. Felt like was going to pass out/weak  - patient was seen by Dr. in office.
Dizziness & Seizures Narrative: EMPLOYEE REPORT FEELING DIZZY ON THE MORNING AFTER RECIEVING THE VACCINE.HE LOST CONSIUOSNESS IN THE  BATHROOM AND FOUND IS WIFE HAD CALLED 911 FOR HIM.HE WAS UNCOUNCIUS FOR ABOUT 30 MINUTES.
Sub dural brain hemorrhage; Thrombocytopenia; ITP; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0176) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number=1, product=COVID 19,, brand= Pfizer,, lot number=ER8731, administration date=21Apr2021 , vaccine location=Left arm), administration date: 21Apr2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (hospitalization, medically significant, life threatening) with onset 09Nov2021, outcome "recovered with sequelae", described as "Sub dural brain hemorrhage"; THROMBOCYTOPENIA (hospitalization, medically significant, life threatening) with onset 09Nov2021, outcome "recovered with sequelae", described as "Thrombocytopenia"; IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant, life threatening) with onset 09Nov2021, outcome "recovered with sequelae", described as "ITP". The events "sub dural brain hemorrhage", "thrombocytopenia" and "itp" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of cerebral haemorrhage, thrombocytopenia, immune thrombocytopenia.  Clinical Course: Patient had no other vaccines in four weeks and no other medications in two weeks. AE treatment included surgery. Patient was not tested covid prior vaccination. Patient was tested covid post vaccination. Patient had no known allergies.  No follow-up attempts are needed. No further information is expected.
1/18/00, stated child had enlarged liver & jaundice, as examined per a friend. 1/19/00, went to MD Dr, stated MD is not sure of DX & cause but has drawn labs.
Progressive weakness and muscle atrophy in lower extremities, L>R with intermittent parathesias.  3rd vaccine given around Sept. 9 and unusual gait noticed shortly after. 2/23/09-records received-presented on 11/25/08-with C/O left lower extremity tightness, tingling and leg cramps. Limping. Fainted prior to 12/23/08, weak spells, left leg continue to have tingling. PE developing cavus deformity of foot and muscle wasting of left calf. initial complaint 9/12/08.  Now blance difficulties. Neurolgoy consult 1/20/09-presented with C/O foot weakness and 4 month history of balance problems. Gait changes, waddling. C/O loss of sensation at left big toe, increasing clumisness while walking, including tripping and rolling her ankle. Episode of numbness and tingling of hands when rock climbing, muscle cramps in legs. PE: revealed heel cord tightening, left foot drop.Treated with IVIG. 2/11/09-neurolgoy follow-up, decreased DTRs, positive Babinksi and heel cord tightening.  Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms. Hospital records for DOS 1/21-1/25/09-DC DX: Inflammatory polyneuropathy.  2/11/09-follow-up visit, No progressive weakness over last 2 months with no change in symptoms.  2/11/09-follow-up visit-over last 2 months has shown no progressive weakness no change in symptoms, wearing ankle-foot orthotics. Feeling well able to walk easier not running. PE: decreased DTRs, positive Babinski and evidence of hell cord tightening. IVIG treatments monthly. Office 3/4/09-Holter monitor showed episode of asymptomatic tachycardia. Impression acquired immune neuropathy versus genetic diseases.  4/13/09 CDC staff, FDA staff and UCSF neurologists reviewed VAERS # 339034 and have concurred that their patient originally diagnosed as CIDP is really juvenile ALS.
Kinrix to a 8 months old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Sep-2022 Reporter's Comment: The case was reported by the nurse. Nurse stated administration of Kinrix to an 8 months old patient. Nurse did not report any additional information apart from the age of the patient and the vaccine administered. Nurse did not know patient´s initials and gender and any information regarding vaccine lot number and expiration date. Additional supportive information: As Kinrix was administered to 8 month patient which led to inappropriate age at vaccination.
Vaccine administered to the patient past the 12 hours after the vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient past the 12 hours after the vial was punctured) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient past the 12 hours after the vial was punctured). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient past the 12 hours after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was an HCP stated that the pharmacy opened the Moderna vial for booster doses on 29-Nov-2021 and they used it past the 12 hours. The patient received the booster dose on 30-Nov-2021.  It was reported that the vial was initially stored in the refrigerator on 15-Nov-2021 and the vial was first punctured on 29-Nov-2021 around 9:00 AM. The date of administration of vaccine was 30-Nov-2021 from 9:30 AM to 10:30 AM. The vial was stored back in the refrigerator post puncture. The reporter also stated that the vial didn't undergo any temperature excursions.  No Concomitant product use was reported. No treatment information was provided.
Injection site arm hurt from shoulder down to my elbow. Not sharp pain, achy.  I took 1 naproxen 500 which I use occasionally for my arthritis and it helped alot.  It was still slightly achy until March 11, 2021.
Dry mouth; Lethargy; Severe chills; Fever of 101.4; Headache; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical histories. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 14:00 (24 hours post vaccination), the patient experienced severe chills, fever of 101.4, dry mouth, severe headache and lethargy. The patient experienced severe headache for three days post vaccination and was still having a milder headache in the morning. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of chills, fever, dry mouth and lethargy was resolved with sequelae (reported as recovered with lasting effects). The clinical outcome of the event headache was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.
Sore throat, and congestion then woke on 10/3/2014 with swollen eyes.
Elevated heart rate - 156/96 (pulse 125). Later pulse decreased to 96. Patient has history of anxiety. Improved with water intake.
He started with a high fever that ended up with a siezure since the seizure he has complained of constant pain ans severe headaches with vomiting and light sensitivity he is not speaking as well as he did prior and is disoriented and unbalanced constantly and he has ran a constant low grade fever since the shots.
inflamed arm at the injection site; inflamed arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received BNT162b2 (COMIRNATY), on 14Dec2021 as dose 3 (booster), single (Lot number: 33130BA) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "recovering" and all described as "inflamed arm at the injection site". Therapeutic measures were not taken as a result of vaccination site inflammation, vaccination site pruritus.  Additional information: Patient reports itchy and inflamed arm at the injection site of last vaccine administration months after receiving dose. The patient did not have COVID prior vaccination and it was unknown if the patient was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Beginning the day after the shot, I did not have much strength and my stomach became very acidy. On Wednesday after the shot, I slept practically all day. Thursday through Saturday my strength came back some, but my stomach was still very acidy. Sunday, the 11th, I was better and had more strength. Today, Monday the 12th, I feel much better but still have an acid-stomach. I?ve been told by the pharmacist at my regular pharmacy store that reactions should really only last a couple of days, but mine lasted a week.
Fever of 100.6, chills, severe aches and pains, inability to conduct normal activities. Serious enough that I won't consider the booster, won't do this again.
chest pain; difficulty breathing; This is a spontaneous report from a contactable nurse. A 20-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL9581), via intramuscular, administered in Arm Left on 18Feb2021 (at the age of 20-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number=EN9262) via intramuscular route of administration in left arm on 22Jan2021 as 1st dose, single for covid 19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021 03:00, Patient reported chest pain and difficulty breathing and reported to ED. He was given Benedryl and morphine and stated that he was fine four hours later. He followed up with his PCP. Therapeutic measures were taken as a result of chest pain (chest pain), difficulty breathing (dyspnoea). Treatment received for the adverse event was Benedryl and morphine. The outcome of the vents was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted event chest pain cannot be excluded based on a compatible temporal relation.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. In July 2017, the patient received the 2nd dose of BEXSERO. On an  unknown date, 1 day after receiving BEXSERO, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the  injection site erythema and injection site pain to be related to BEXSERO. Additional details were provided as follows: In June 2017, the patient received 1st dose of BEXSERO. In July 2017, the patient received 2nd dose of BEXSERO and developed pain and erythema at injection site about 2 inches in diameter. The patient required emergency room visit and returned to doctor's office the next day for further assessment of the area following the reaction. No further information was reported regarding the event.
Left thigh where MENACTRA and MEN B were given=red, warm, swollen, hard, -gold ball size.
My period came weeks early the day after my first dose. I?m not in as much pain like a regular period but I?m still bleeding/spotting 2 weeks out. Low to moderate bleeding.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 19-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113:
around 8PM pt got a fever 103.5 rolled eyes shaking of arms, foam in mouth-911 was called they gave pt some 02 @ ER did blood & urine test & gave pt motrin for fever;febrile sz
I noticed discomfort in the area below my right shoulder blade while driving home from work.  After arriving home, I discovered a red rash in that area. Subsequent to calling pharmacy and then going to an urgent care center (where I was diagnosed with a non-specific dermatitis), I applied Cortaid to the rash at bedtime.  The rash had slightly subsided as of 10/30/15 A.M.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 35-day-old female with no medical history or allergies, who on 20-NOV-2006 was vaccinated intramuscularly with a second dose of Recombivax HB. There was no concomitant medication. On 21-NOV-2006 the baby broke out in a rash. Unspecified medical attention was sought and no laboratory or diagnostic test were performed. Subsequently, the patient recovered. No product quality complaints were involved. Additional information has been requested.
h/a, cold sweats, mild chest tightness, tingling, mild GI upset; resolved w/in hr p/taking some DPH & APAP;
Patient received Jansen Covid vaccine on 3/31/21. He presented to clinic on 10/25/21 for booster vaccine. He was administered fill dose (0.5mL) of Moderna vaccine as booster instead of 0.25mL dose.
Lymphadenopathy to Right axilla, fever, body aches, chills, injection site erythema/pain/swelling
DUE TO THE FINDING ON 6/26/2020 WHEN REVIEWING THE PATIENTS CHART FOR UPCOMING VISIT I NOTICED THE  VACCINE ZOSTAVAX WAS GIVEN BACK ON 12/04/2018 VERSES A VARICELLA VACCINE FORTHE PATIENT.  AT THE TIME THERE WAS NO REPORT BY THE PARENTS AFTER THE INJECTION THAT THE CHILD HAD ANY REACTION.  IN THE PAST YEAR AND A HALF WE HAVE SEEN THE CHILD TWICE  AND THERE NO REPORTED COMPLAINT BY THE PARENTS THAT THEY NOTICED ANYTHING DIFFERENT WITH THE CHILD.
after first dose, patient experienced laryngospasms while in the office; This spontaneous report was received from a nurse practitioner via a company representative regarding a 2-month-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies were unknown by the reporter, however it was reported that there might have been other vaccinations (non oral) on an unspecified date (reported as "that day").  On an unspecified date (also reported as "about 1.5 to 2 years ago"), the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for rotavirus (lot number, expiration date, dose and frequency were not reported).  While in the office for the 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), after being administered with the first dose, the infant experienced laryngospasms. No treatment was given for this adverse event (AE). No laboratory diagnostics or studies were performed regarding the event. The patient sought medical attention. Limited information was provided by the reporter. The patient recovered from the event in 15 to 20 minutes.   The relatedness between the event of laryngospasms and the suspect vaccination was not provided.