chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RHEUMATOID ARTHRITIS FLARE UP; This spontaneous report received from a patient via another manufacturer (Abbvie) concerned a 52 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient was previously treated with covid-19 vaccine ad26. cov2. s for covid-19 vaccination (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 01-APR-2021 for  prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date were unknown) dose was not reported, 1 total administered on 01-NOV-2021 for prophylactic vaccination (dose number in series was 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient received additional non-company suspect Humira (Solution for injection in pre-filled pen, subcutaneous, batch number and expiration date were not reported) dose was not reported, for moderate to severe rheumatoid arthritis.  No concomitant medications were reported.  On unspecified date in NOV-2021, the patient experienced rheumatoid arthritis flare up (dose number in series was 2). Laboratory data (dates unspecified) included: Blood test (NR: not provided) not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with Humira was unknown. The patient had not recovered from rheumatoid arthritis flare up. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211217128-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned an 87 year old White and Non Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) 1 total, dose was not reported, administered at right arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  Patient needed a blood test after she was vaccinated and patient asked the doctor to check for antibodies against covid-19. On 05-OCT-2021, it was reported that patient had less than 1 %, that means patient had no antibodies (Confirmed immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative, Less than 1% (No antibodies). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000196260.; Sender's Comments: V0:20211011984-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
After receiving Tdap patient had swelling at injection site which spread to shoulder/back. Reaction happened within 5 mins of receiving vaccine. Given 25 mg of BENADRYL. Sxs began to resolve while being monitored in office. Prednisone 40 mg given to hold in case of systemic reaction.
Pneumovax administered 11/21/05 in left upper arm. Received a phone call from patient on 11/22/05 that her arm was stiff and sore. Was advised to apply cold compresses for 48 hours. On 11/23/05 presented to office. Arm was significantly  red fro elbow to axilla area - completely around but not involving injection site area. Hot to touch. Most pronounce redness and heat was ulnar aspect above antecubital area at hands breadth in size.
EMT and PHN responded to Pt hunched over, C/o sudden onset of abdominal cramping and pain, 7/10, and throbbing HA 7/10 pain. Denies dizziness, nausea, itchiness, swelling. Vitals taken at 1:53 pm: BP 510/88, HR 60. Pt request to go to bathroom, ambulated self with steady gait to restroom. Pt assisted by son, in bathroom. NO BM, reports pain comes and goes from 7/10 to 3/10.. Pt walked back to reclining chair in vaccination observation area. Vitals recheck at 2:13: BP 156/90, HR 52, 28 respirations., reports no change in pain or HA. Pt wincing and bending over, 9-1-1 activated, EMS on scene at 2:20 pm. Pt refused ED transport/and care, Pt walked off site with son, states will go to clinic ASAP.
Varicella vaccine given too early. MMR vaccine given on 6/29/22 per other registry patient brought with. Nurse called and spoke to MD regarding vaccine requirements. Nurse reviewed with MD the dates of MMR and COVID-19 vaccine given per other registry. MD gave verbal order to give vaccines administered on 7/14/22 and nurse ordered the vaccines. Live vaccines require a 4 week gap unless they are given at the same visit. Varicella was given to patient on 7/14/22 and will not count as a valid dose as 4 weeks has not passed since MMR was given on 6/29/22. No observable signs of injury to the patient post-vaccine administration.
Admitted to hospital unit from clinic appt with critical K+, increased SOB, and COVID postiive.  He is also s/p TVAR 1 week.    Discharged home on 1/12/22, and expired following cardiac arrest.
This is a spontaneous report from contactable consumer or other non-HCP. A patient, of unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient experienced headache, 102ºF fever and fatigue. The patient underwent lab tests and procedures, which included body temperature: 102ºF fever on an unspecified date. The outcome of the event: unknown (at the time of report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
mom noticed eye rolling & stiffening of upper extremities;these episodes happened every 5-10min & lasted about less than 30seconds;adm to hosp for observation;these episodes lasted about 4hr;
Patient has refused second dose of vaccine due to adverse effects of the first. "Flu like symptoms, pain at the injection site."
symptoms 01Jan2023 ST mild cough home Ag positive 02Jan2023; symptoms 01Jan2023 ST mild cough home positive 02Jan2023; prev_dose_brand=Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 3 (booster), single (Lot number: Cj6742) at the age of 41 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Nov2022, outcome "unknown", described as "prev_dose_brand=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2023, outcome "unknown" and all described as "symptoms 01Jan2023 ST mild cough home Ag positive 02Jan2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Positive, notes: home test, Nasal Swab. It was unknown if therapeutic measures were taken as a result of interchange drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "interchange of vaccine products", "drug ineffective", "COVID-19".
Shot received 3/25/21. 3/26/21: fatigue, headache, pain in left arm and neck 3/27/21: rash on left arm and left leg, swollen lymph in left armpit
Pt received his 1st moderna covid 19 vaccination on 4/8/2021. He was admitted to hospital on 4/15/2021 with c/o sudden loss of consciousness x 2 that morning after his AICD fired at home. Interrogation of the AICD noted recurrent episodes of ventricular tachycardia. He also tested positive for covid 19 on admission. He was ultimately discharged/transferred to another hospital on 4/28 after 7 days having been treated with amiodarone and lidocaine drip. He was hospitalized at this facility until his discharge to a covid rehab facility on 5/5/2021 as he is still testing positive for covid 19.
Headache Narrative: inj site soreness and hard to lift up arm; fatigue, back pain, L neck pain hard to turn head, weakness, tiredness, headache; used acetaminophen to help with symptoms
Flu like symptoms, tired, headaches, body aches, coughing, burning sensation in my tongue, feet and hands temporarily , panick and cold sweats
Worsening redness, swelling, warmth, pain at site of injection, right deltoid.  Intermittent numbness to right hand/fingers.
took it have gotten shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter reported that she/he know many patients that took Shingles vaccine and gotten shingles. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient who was a nine month old was administered the third dose of oral ROTATEQ (lot number, expiry date and route were not reported), orally. No adverse effects reported. Additional information has been requested.
I have Bursitis in upper left arm and it is prolonged. I also felt really bad after the vaccine for about 24 hours and it went away except the Bursitis.
This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID: (159558). A 5-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (orange cap), single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "Pharmacist seeking guidance after administering undiluted orange-cap Covid vaccine to 5 year old patient."; RASH (non-serious), outcome "unknown", described as "caller reported a rash on patient's neck.". Additional information: It was reported that the patient was waiting for vaccination. They were accidently administered a COVID 19 vaccine to a patient without diluting. The patient's mom and dad are outside. The patient had a rash on his neck. She just wants to know what to do. She was filling in at this store today. Pharmacist was seeking guidance after administering undiluted orange-cap Covid vaccine to patient. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No Adverse reaction, patient was given 1st dose of Moderna on March 27th, when patient arrived for 2nd dose it was identified that they were under 18
I had a breakthrough case, tickle in throat, shortness of breath, congestion insomnia, hair loss. Lost my voice, sinus pressure.
Beginning same day, severe intermittent each ache in right ear only. Continuing during the following day (Saturday)
persistent bruise about  1 inch by 2 inches that patient said appeared after 2 days. and has not resolved by 11/20/2020
This spontaneous report was received from a consumer refers to a friend, patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, strength, route were not reported, lot number and expiration date). Co-suspect and concomitant therapies were not reported. On an unknown date the patient developed shingles after receiving dose of ZOSTAVAX. At the time of the report the outcome was unknown. Additional information is not expected.
Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit
Tightness, swelling, redness, fever, nausea. Treated with BENADRYL-still taking it.
Received vaccine Saturday Feb 27th 3 hours after shot starting having chill and body aches 5 hours after shot high fever up 103,  Sunday Feb 28th evening started taking Tylenol every 6 hours to reduce fever. Monday March 1st a severe rash began on the arm where the vaccine was given. Rash covered the whole area on front of the arm and area where the shot was given. It was patchy red, extremely itching and painful to the touch started using Hydrocortisone Cream to relieve the itching. Rash slowly subsided by March the 5th rash disappeared.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were received as follows: This case was reported by the patient. The age at vaccination was not reported. The patient experienced soreness at the injection site.
Case number PHHY2012US051907 is an initial literature report received on 12 Jun 2012, Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received INFLUENZA from 01 Jul 1999 through 30 Jun 2009. This case refers to a baby born (sex not specified) to mother (age not specified). The mother was vaccinated with INFLUENZA (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009 (see linked mother file: PHHY2012US051905). The fetus was exposed to this vaccine via transplacental route. On an unknown date at an unspecified gestational period, the baby was born. The baby developed jaundice on an unspecified date. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of INFLUENZA vaccine.
stated w/few spots on 1NOV by 4NOV more spots & on face; feverish to MD-MD did not feel it was related to shots; felt it was a skin infect however 530PM t103 & pt vomited, has been lethargic since that time; still has rash;
Sore arm after injection; This is a spontaneous report from a non-contactable consumer. A patient of unknown gender and age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date the patient experienced sore arm after injection. The clinical outcome of the event sore arm after injection was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter information and narrative were amended.
raised crusty bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (raised crusty bump) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0xgl21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (raised crusty bump). At the time of the report, VACCINATION SITE SWELLING (raised crusty bump) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
On May 4th I began to experience sinus headache, post nasal drip and cough. On May 5th the headache increased terribly, nasal congestion increased, and cough worsened.
Patient appeared to have fainted. He fell as he was leaving the building after being observed for 15 minutes following his vaccination. He sustained a laceration to the back of his head on the left-side and also to his left elbow. Pressure was applied using sterile gauze to both lacerations. EMS was called, arrived about 10-15 minutes following the incident, loaded him onto a cart and transported him to the ambulance for further evaluation.
Vaccines were kept frozen until they are ready for administration; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated. No treatment medication was provided by reporter.
Information has been received from a pharmacist via company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot#, expiration date, dose, strength and route were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Moderna COVID-19 Vaccine EUA consistent elevated bpm 80-147, chest pain, shortness of breath, dizziness, fatigue day 1 to current day 6.  Severe body aches on day 1.  Bilateral axillary lymph node swelling and tenderness day 2 to current day 6.
difficulty breathing dec B/S both lungs; BP 130/110-88 c/o vertigo; face flushed; watery eyes & nose; no relief & inhaler & rest taken to ER;
Cough. Body aches Sharp pain shoulders, neck, torax. Could not move his head, could not move his arms. Fever, chills. Short breath Sharp pain right wrisk (fractured long ago and healed) - X-Rays showed arthritis.  He did not complain before or it did not bothered before. A sharp pain in a specific point of his head (Right - front - up side). Not being able to laid down. Moving hurts.
This spontaneous report was received from a nurse (also reported as "medical assistant"), concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were subcutaneously vaccinated with improperly stored doses of VARIVAX injection (dose and frequency were not reported) lot # M040139 with expiration date of 24-SEP-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the VARIVAX were properly stored. The temperature excursion of the VARIVAX was between 6 °F and 14 °F for a time frame of 2 hours and 45 minutes and between 15 °F and 46 °F for a time frame of 5 hours and 45 minutes. Also, a previous temperature excursion occurred between 6 °F and 14 °F for a time frame of 4 hours and 30 minutes and between 15 °F and 46 °F for a time frame of 6 hours and 25 minutes. No side effects were reported. Data logger was involved. Additional information has been requested.