chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified nurse midwife concerning a 23 year old female with no known drug allergies, who on 10-AUG-2007 was vaccinated with a first dose of Gardasil (Lot # unknown) at another office.  On 13-NOV-2007 and 20-FEB-2008 the patient was vaccinated in the left deltoid with a second and third dose of Gardasil (Lot # 659437/1266U & 659655/1486U), respectively.  Concomitant therapy included SEASONIQUE, CYMBALTA and VALTREX, as needed.  On 13-NOV-2007 and the 20-FEB-2008 the patient experienced swelling between fingers of injected arm that lasted 2 days each time.  The swelling between the pointer and middle finger had small bumps on skin.  It was noted that the adverse events were less intense after each injection.  The outcome was reported as recovered.  There were no illnesses at the time of the vaccination.  Additional information is not expected.
Two minutes after the vaccination, PT walked up to the counter and said he feels dizzy.  I asked him to sit down and started walking around the counter to check on him and check his blood pressure. At that moment he fainted and lost consciousness. Another patient caught his head and he did not hit his head. He remained unconscious for 30 seconds and we were preparing to start CPR breaths as he had a pulse but was not breathing.  His eyelids were fluttering.  He regained consciousness at that time and we waited with him until EMS arrived. His blood sugar was very low when EMS arrived.
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 13-Nov-2013. The reporter stated that the patient's nose was bumped during the administration and started the nose bleed after that he did not let us do the second side which started on 13-Nov-2013. The patient recovered form the event of nose bleed on 13-Nov-2013. The patient recovered from the event of nose was bumped during the administration on an unspecified date and the outcome of the event of not let us do the second side is unknown. The event of nose bleed was considered to be non-serious by the reporter. The events of not let us do the second side and nose was bumped during the administration have been identified by the company physician from the source documents and added as non-serious adverse events. Summary of follow-up information received by AstraZeneca/MedImmune on 20-Nov-2013 from a Health Professional: New reporter was added (patient). The outcome of the event of nose bleed was changed from unknown to recovered. Corrected report on 29-Nov-2013: The event onset date of the event of nose bleed was added. Two new events were added (not let us do the second side and nose was bumped during the administration).
After administering the vaccination, I realized that the vaccine was given after the recommended beyond use time. The vial was punctured at 9:15AM on 5/31  and the beyond use time was 3:15 PM. The vaccine was administered to the patient at 3:45 PM, 30 minutes  after the beyond use time of 6 hours. I attempted to reach the patient several times to inform him of this error, but I was unable to reach the patient.
2 mos old infant received 1st Hib vaccine at 930 AM 1/10/08. Pt present 5 hours later, crying, inconsolable with 5x5cm area of swelling, redness, increased warmth around injection site. Treated with ice and Tylenol.
really bad headache; extreme chills; extreme fatigue/exhausted; she wasn't able to eat; feel like pressure in her head; cough/ outcome of the cough persistent; soreness in my arm, right after/left arm was sore where she received the injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient) from medical information team for a Pfizer sponsored program.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 10:45 (Lot number: FC3180) at the age of 49 years as dose 2, single for covid-19 immunisation. Family history included: "high blood pressure" (unspecified if ongoing), notes: her mom has high blood pressure but patient's blood pressure is fine. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: FA7485, Dose: Unknown strength/volume/dose injection to left arm at 15:25), administration date: 08Aug2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Aug2021, outcome "recovered" (31Aug2021), described as "soreness in my arm, right after/left arm was sore where she received the injection"; HEADACHE (non-serious) with onset 07Sep2021, outcome "recovered" (Sep2021), described as "really bad headache"; CHILLS (non-serious) with onset 07Sep2021, outcome "not recovered", described as "extreme chills"; FATIGUE (non-serious) with onset 07Sep2021, outcome "recovering", described as "extreme fatigue/exhausted"; EATING DISORDER (non-serious) with onset 07Sep2021, outcome "unknown", described as "she wasn't able to eat"; HEAD DISCOMFORT (non-serious) with onset 07Sep2021, outcome "unknown", described as "feel like pressure in her head"; COUGH (non-serious) with onset 07Sep2021, outcome "not recovered", described as "cough/ outcome of the cough persistent". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Consumer administered 2nd dose Pfizer-BioNTech Covid-19 Vaccine 29Aug2021.Onset of side effects 07Sep2021: slight headache, extremely fatigued. Took COVID test 07Sep2021 which came back negative.08Sep2021 onset of extreme chills, still had extreme fatigue and sometimes when would stand up would feel like pressure in head; gets this cough every now again that just shows up, unknown if it's from the chills or sweating; but the cough is not constant, it just comes out of nowhere. Cough started when started getting chills-cough persistent, kind of the same.    No follow-up attempts are possible. No further information is expected.
High fever, chills, uncontrollable shaking/teeth chattering, nausea.
After both vaccine patient observed blood in one right side ear; blood can be feel on earbuds; This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (After both vaccine patient observed blood in one right side ear; blood can be feel on earbuds) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR HAEMORRHAGE (After both vaccine patient observed blood in one right side ear; blood can be feel on earbuds). At the time of the report, EAR HAEMORRHAGE (After both vaccine patient observed blood in one right side ear; blood can be feel on earbuds) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received and contain non significant information.
This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 27-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot number: L017406, expiration date 26-FEB-2017 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
pt recv vax 22MAR95; 26MAR itching, light rash 27MAR saw MD rash over entire body w/itching & fever; MD told pt had rubella D/T shot; swelling of face, arms & trunk; father stated pt red all over body; swelling like hives-ERMD not rubella
2 month old infant received PENTACEL, PREVNAR 13, HEPATITIS B and ROTARIX on 11/18/2010 in afternoon and spiked fever of 103 degrees F - approx. 4 hr later. Seen in ER - benign exam. Seen in office 11/19 - Exam suggested viral pharyngitis, however no fever - T 99 degrees F.
15 to 30 minutes after influenza vaccine administration patient complained of a 'weird taste in mouth and a tight throat." Her BP and pulse were normal at 30 minutes and 45 respectively (120/68, pulse 72 and 116/80, pulse 74) with no evidence of bronchospasm, difficulty breathing, swelling of face/tongue or redness. She was given a 50mg oral dose of diphenhydramine since she did not meet protocol criteria for epinephrine administration at this time. Approximately 50 to 60 minutes after influenza vaccination, patient's  bp and pulse were beginning to rise (136/89 with pulse 93) and she began to experience palpitations, dizziness, sweating and itchy,red palms. At 6:48pm a 0.3mg EPi-pen was administered in right outer thigh by lead immunizer, and EMS was notified. EMS arrived at approx. 7pm and took over care and monitoring of patient. They administered oxygen and continued to monitor bp, pulse and checked cardiac rhythym. At no time did patient become unconscious, stop breathing or require CPR. Paramedics noted increased bp/pulse most likely due to epinephrine administration. EMS and lead immunizer advised patient to seek follow-up care and she was released by EMS at 7:30pm after signing a release that she refused to be taken to the hospital.
Patient received the Afluria and Shingrix vaccines on 09/16/19 in the same arm 1 inch apart.  Patient reports muscle pain at injection site for the last 1.5 months with interference with daily activities such as putting on clothes.  Patient reports that there is no external swelling or redness at the site of injection.
Started with a low grade fever, that evening into the next day severe headache, body aches, chills and temperature. Friday afternoon fever was 104, very severe body aches and headache. I was brought to the ED at 2:30 in the afternoon. Upon arrival I was vomiting and passed out. After being treated and discharged home I continued with headache and nausea, which continues until today (Tuesday) the 9th.
This spontaneous report was received from a pharmacist and refers to a 18 year old patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection, 1 dosage form (route of administration, lot # and expiration date were unspecified) for prophylaxis. On an unknown date, the patient experienced drug administered to patient of inappropriate age. No adverse event was reported.
2 days after vaccine administration, she developed a fever to 103.7 and subsequently diffuse rash. Worse at site of injection with large patch. Admitted 5 days after administration, diagnosed with Stevens Johnson Syndrome via biopsy and clinical status. Received IVIG 1mg/kg x 3 days. 9/29/09 MR received for DOS 9/11-19/2009 with D/C DX:  Stevens-Johnson Syndrome. Pt presented with maculoapular rash and fever. Pt developed hypotension and shock and was admitted to the PICU. Tachypneic and on O2. Tx IVIG.
Information has been received about a pt who on same day of vaccination developed edema right arm , wrist to shoulder for 4 days. On 10/08/00 the pt recovered.
Severe rash on right shin and abdomen; Severe rash on right shin and abdomen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Aug2021 10:45 (Lot number: Fc3181) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Administration Time: 10:45 AM, Vaccine location: Right Arm, Lot Number: Fa7484), administration date: 25Jul2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: RASH (non-serious), RASH (non-serious) all with onset 16Aug2021 08:00, outcome "not recovered" and all described as "Severe rash on right shin and abdomen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash, rash.  Additional information: The patient had no other medical history and had no known allergies. Prior to vaccination, the patient was diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. List of any other medications the patient received within 2 weeks of vaccination was noted as none.  Follow-up attempts are completed. No further information is expected.
Mom states Pt woke up around 3am with abdominal pain and covered in hives. Pt went to ER and given SOLU-MEDROL 125mg and Benadryl. Sent home with Rx for prednisone & told to take Benadryl three time today.
Started feeling some left arm, neck, back and thumb soreness 4-5 hours after getting imm. By late evening could not lift left arm. Yesterday had a fever most of the day and last night saw some redness on left arm. Is raised/"welty" Today arm is still sore but can move better. Right arm is a little sore (had flu shot in right arm). Feels "crummy". ST. Feels feverish but no elevated temp.
About 30 minutes after receiving the vaccine, client became syncopal. He was driving a motor vehicle. He pulled over and had his wife drive him to the local emergency room. Wife stated he had seizure like activity including head rolling back, eyes twitching, upper body movement. He also complained of chest pain. He was given an EKG, chest x-ray and blood work. All were normal. Client was given 2 liters of fluid. He had not eaten since 6 am that morning
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023).    No concomitant medications were reported. BUD for vial was reported on 12-Mar-2023 No treatment details were reported.  This case is reported for Patient 1 out of 2 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-717126 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717126:Patient 2 out of 2 Patients
Presented to ER DOA, autopsy pending.  10/7/08 Autopsy states COD as undetermined.  Pathological diagnosis: hyperglycemia, likely related to physiologic stress.  10/7/08 Autopsy report states patient experienced irritability w/teething at time of vaccination.  Infant sleeping in car seat within cluttered closet w/door partially closed & baby monitor in closet.  Parents bedroom (w/monitor found turned off) on another floor in house.  Infant was put to sleep approx midnight but not checked or attempted to be fed until approx 2PM when parent entered closet for clothing. Found unresponsive, damp w/sweat, w/blanket partially over face.  DOA in ER w/core temp of 85.  Autopsy found no traumatic injury.
information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated IM with a first dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). Subsequently the patient fainted and was unconscious for about 15 seconds and then came to. Subsequently, the patient recovered from fainting. Additional information has been requested.
Patient immediately reported feeling extreme, severe pain radiating down his arm right after injection was given. Pain was so severe patient got teary-eyed and described it as one of worst pain he has experienced. He has had a flu shot every year for many years due to his chronic emphysema and has never had a reaction before. This is the first time he has experienced pain so severe in all his years of flu shots. Also the first year he has ever received FLUBLOK QUADRIVALENT. Previously reports no problems with FLUVIRIN, FLUARIX QUAD, FLUZONE, FLULAVAL QUAD.
14 days after vaccination, lethargy, diarrhea, headache, sore throat and congestion. Persisting for 3 days now.
vaccines developed Dermatomyositis; This spontaneous case was reported by a consumer and describes the occurrence of DERMATOMYOSITIS (vaccines developed Dermatomyositis) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DERMATOMYOSITIS (vaccines developed Dermatomyositis) (seriousness criterion medically significant). At the time of the report, DERMATOMYOSITIS (vaccines developed Dermatomyositis) outcome was unknown.            Concomitant medications were not reported.  No treatment information was reported Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected and serious (medically significant) event of dermatomyositis after receiving a dose of mRNA-1273.222, which was the patient's unknown dose of COVID-19 vaccination schedule. Exact onset date for event is not known and dose vaccination date is also unknown therefore the latency cannot be assessed. There is limited information in the case- demographic data, onset dates of the event, vaccination date and consecutive dose number in Covid-19 vaccination schedule, family and medical history, concurrent diseases, concomitant medications, diagnostic workup, treatment and event outcome. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-713514, US-MODERNATX, INC.-MOD-2023-713516 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713514: US-MODERNATX, INC.-MOD-2023-713516:sister case
A spontaneous report has been received from a Physician concerning, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient reported received expired FLUMIST which started during 2014. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Pt in center. Went to center to administer Hep A and COVID vaccine. Pt stated he wanted to receive Hep A vaccine. Pt asked if he had received Hep A vaccine prior and patient stated he had not. Upon further evaluation when putting records into system patient had received pediatric series on 7/25/2007 and 05/07/2008. Pt notified of receiving extra dose of Hep A. No adverse events noted.
Pt recvd vax  on 12OCT92 & 14OCT92 devel profuse sweating, itching & a red rash around ankles, lower back, bilateral wrists;
Missed to take her 4th dose; took it 3 days later; A spontaneous report was received from a pharmacist on 15SEP2022. It described a female patient of unknown age who "missed to take her 4th dose; took it 3 days later" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first 3 doses of Vivotif as per recommended schedule but did not take her fourth dose of Vivotif as per schedule and took it 3 days later. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient missed to take her 4th dose; took it 3 days later (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient missed to take her 4th dose; took it 3 days later (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (dosing details were not reported) (lot # K019502, expiry date: 04-FEB-2016) which was expired. The reporter could not provide a date of administration for the expired dose. No adverse effects were observed in the patient. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
pt recv vax 1MAY97 & pt exp swelling, redness, & heat in rt arm, arm which was vaccinated;pt was taken to ER & was hosp;No further details were provided;