chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 07/Sep/2006 from a nurse.  A 24-year-old female patient with a past medical history of three pregnancies that resulted in the delivery of three, live, full-term babies, and who currently takes ranitidine for nausea had received a 0.5 mL intra-muscular dose of ADACEL, lot number C2457AA, in the left deltoid on 07/Jul/2006.  The patient had a negative pregnancy test at the time of the vaccination.  The date of the patient's last menstrual period was 15/Jul/2006, and her expected date of delivery is 03/Jul2007.  On 31/Aug/2006, the patient had an ultrasound to determine the expected date of delivery, and a small subchorionic hemorrhage was noted.  According to the reporter, the patient had not experienced any adverse events since the vaccination on 07/Jul/2006.  A corrective version was created for the sole purpose of adding the adverse event previously reported of sub-chorionic hemorrhage that was noted on ultrasound on 31/Aug/2006.  No new information was received.
Bilateral tinnitus Bilateral tinnitus started the same day that the vaccine was given. Persistent until telemedicine visit two days later.  No history of tinnitus.
Tonsillitis. Treated with prednisone 5-day pack and 10 days Amoxicillin.
can't even move my both arms; This case was reported by a consumer via interactive digital media and described the occurrence of injected limb mobility decreased in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included pain in arm.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the injected limb mobility decreased to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that arm was very painful and then at the other arm he/she had the flu shot.  The patient could not even move his/her both arms. The follow-up could not be possible as no contact details were available.
Information has been received from a register nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expiration date were unknown). On an unknown date the patient experienced a rash after receiving the ZOSTAVAX. The outcome of rash was unknown. Additional information is not expected as the physician asked not to be contacted.
Patient was administered Gardasil 9 after administered first dose of HPV series (unknown if it was Gardasil Quadrivalent or Gardasil 9); 25 year old patient was administered Gardasil 9 on unspecifieddate after was administered first dose of HPV series as 11 year old; No adverse effects reported; This spontaneous report was received from a physician, referring to a 25 year old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug allergies or reactions, and concurrent conditions were not reported.      On an unknown date, reported as "the patient was 11 years-old", the patient was vaccinated with the first dose of Human Papilloma Virus (HPV) series; however it was unknown if the vaccine administered was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, frequency, route of administration, anatomical site of vaccination, lot # and expiration date were not provided).  Afterwards, on an unknown date, when the patient was 25 years-old, a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered (strength, frequency, route of administration, anatomical site of vaccination, lot # and expiration date were not provided) (interchange of vaccine products and inappropriate schedule of product administration). No adverse effects were reported.
Three unspecified patients received improperly stored VAQTA, lot# L0154607 exp. 20-JUL-2017; three unspecified patients received improperly stored VAQTA, lot# M011839/ exp. 13-SEP-2017; This spontaneous report as received from a certified medical assistant refers to 6 patients of unknown demographics. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On an unknown dates, three patients were vaccinated with improperly stored doses VAQTA which had a lot number of L015460 with expiration date on 20-JUL-2017 and three patients were vaccinated with VAQTA which had a lot number of M011839 and expiration date on 13-SEP-2017  (doses, routes of administrations and anatomical locations were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. As, on 09-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. The narrative was updated.; Sender's Comments:  US-009507513-1611USA000313: MERCK 1610USA003123:Mfr number.
1st one she felt a little foggy and maybe just a little tired; 1st one she felt a little foggy and maybe just a little tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (ongoing), notes: Osteoporosis, takes Prolia 60mg subcutaneous injection twice a year. diagnosed 7 years ago.; "Asthma" (ongoing); "arthritis" (unspecified if ongoing), notes: little bit of arthritis doesn't take medication for this. Gets injections like gel injection in knee for arthritis as needed. Doesn't know the name of medication. Not a steroid it's a gel not cortisone. Got 1st injection last Oct2022; "left branch bundle blockage has had all her life" (unspecified if ongoing), notes: left branch bundle blockage has had all her life. takes no medication for this and there is no treatment. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). The following information was reported: BRAIN FOG (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "1st one she felt a little foggy and maybe just a little tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : Covid vaccine detail : 1st one she had was Oct2021. Clarified she thought first one was 19Mar2021. She had 3 in 2021. March, April and October. All were Pfizer Covid vaccines. 1st one she felt a little foggy and maybe just a little tired.
Approx 30 min after receiving basic vaccines the patient began to break out in hives over his body. mostly on the back of his head and back of his truck though he complained of itching all over.
high fevers; uncontrollable body shakes; teeth chattering; Intense headaches; chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0161) at the age of 29 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fevers"; TREMOR (non-serious), outcome "unknown", described as "uncontrollable body shakes"; CHILLS (non-serious), outcome "unknown", described as "teeth chattering"; HEADACHE (non-serious), outcome "unknown", described as "Intense headaches"; CHEST PAIN (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, tremor, chills, headache, chest pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300024971 same reporter/patient/product, different dose/AE;
shortness of breath, airway obstruction (blood/mucous), several asthma attacks, coughing, vomiting, bloody mucous/vomit, extremely high fever, body chills, aches, headache, vertigo, bladder urgency/incontinence, throat rawness, eye pain & pressure, double vision, poor muscle control
emale client received her first dose of Covid Vaccine (Pfizer, Lot # ER8729, Expiration date: 07/31/2021) at 1132. This minor client, accompanied by her mother proceeded to the observation room for her 15 minute wait period.  Co-lead RN, was present in the observation room assessing another client.  At 1137 this client's mother loudly voiced from the back of the room, "she's feeling dizzy" and co-lead observed client was hanging her head.  Co-lead and EMT1 hurried to her side, and client stated she was feeling lightheaded and dizzy and was suddenly pale and diaphoretic.  EMT1 immediately transferred her from chair to floor with full assistance to prevent a fall/injury.  Client was placed in trendenlenburg position by elevating feet and placing them on the chair.  Client was unresponsive for about 15 seconds until she regained consciousness and returned to baseline mentation.  Client verbalized she "blacked out" and did not remember being placed on the floor.  Client denied pain and respiratory distress. EMT1 called 911 at 1138.  Client and her mother deny she has any medical issues, allergies, medications, or previous incidence of syncope.  At 1145, first set of vitals taken by EMT1 indicate hypotension and bradycardia as follows: BP 68/44, HR 58, and RR 16. At 1145 paramedics arrived and assumed care after receiving report from EMT2.  At 1150 medics took VS with BP 70/50, HR 54, and blood glucose 95, and determined they would start an IV to administer a 500cc bolus for dehydration and to improve BP. Client was also placed on 2L O2 for comfort, no desat noted. At 1200, medics advised client's mother and co-lead they would transport client to the Hospital for further evaluation.  Medics departed at 1205 to transport client to the hospital.
Other complications following immunization, not elsewhere classified, initial encounter on 2022-01-28.
02/03/22 presents to Surgery for "undergo a deceased donor renal transplant". PMHx of "end stage renal disease secondary to diabetic nephropathy, on Hemodialysis"
Narrative:  1/18/23 - Pt presented to ED with fatigue x 3 days, mild sore throat, and productive cough since 1/17 after caregiver visited him. Per EMS, Pt 92% at room air upon arrival, then 98% on 2L O2. Pt reports pain to bilateral hips and legs x 1-2 months. No SOB, fever, or chest pain reported. Provider discussed EUA med. options with patient and Pt would like to take medication for COVID-19. Pharmacy consulted for med. options and paxlovid is not an viable option d/t Rx medications. PLAN: dc home (daughter is a nurse that will assist w/care) pcp f/u customary precautions d/w pt RX GUAIFENESIN RX INV-MOLNUPIRAVIR 200MG ORAL CAP TAKE FOUR CAPSULES BY MOUTH TWICE A DAY *SWALLOW CAPSULES WHOLE* 1/19/23 - Pt returned to ED 1/19 at 00:15 with SOB and states he has been feeling SOB x1 day after testing COVID positive. Pt stated he became so weak at home he could not even sit up in bed or go to bathroom. Pt to be admitted for inpatient care. Primary diagnosis = COVID-19; secondary diagnosis = weakness. **inpatient admission from 1/19/23 to 1/23/23** PRINCIPAL DIAGNOSIS (Reason for admission after study): covid infection, acute in extreme elder. ADDITIONAL DIAGNOSES: weakness due to covid headache due to covid HX of Pulmonary emboli on anticoagulation subtherapeutic INR in pt on warfarin for pulmonary embolism Hospital Course: Pt is a 85 yo male with pmhx of HTN, COPD, hx of PE 2019 on warfarin since then and hx of diverticular GI bleed 2019 who presented to agency ED on 01/18/2023 with cough, congestion and weakness. Pt was admitted to ward for COVID Infection, was afebrile, O2 sat 95% RA, was placed on and completed remdesvir x3d. given supportive care and melatonin to sleep. Pt c/o Weakness due to covid, so PT consulted, rec STR and OT consult 01/19: rec STR w DME , His slums score 17 = dementia; ppd negative 01/22/23,a nd daughter had agreed to STR, howver at time of dc pt decided he wanted to go home. Pt still w capacity this admission but has some memory issues Pt missed dose of warfarin while inpt on the medicaiton for PE, was given dvt coverage w lovenox while inpt, and INR did not reach therapeutic at time of dc ( 1.35). Discussed coverage at home w anticoag pharma, feel his INR will recover in a timely way at home. apparently warfarin was choosen in 2019 due to ease of reversibility with history of GI bleed hx, pt was placed on pantoprazole BID He is a full code, was taking po well, and afebrile, HDS at time of dc.
Case number PHEH2015US000726, is an initial spontaneous report from a physician received on 06 Jan 2015. This report refers to a 37-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered only MenCYW-135 liquid component of MENVEO (batch number: M14044) without being reconstituted with MenA, intramuscularly on 01 Jan 2015. No adverse event was reported following the administration error.
Pt died less than two hours after vaccine. Tentative diagnosis  - SIDS. Former premature baby with in utero marijuana exposure. Autopsy report rec'd 10/25/2005, box 7 complete., COD stated as SIDS.
This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Lot#, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later. And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
Patient received her second dose of the COVID 19 vaccine today. She has had anaphylaxis to allergy shots in the past, but did not have reaction to first dose COVID 19 vaccine. Patient received second shot and started coughing, felt throat closing. Benadryl 50 mg PO was given to her prior to being transferred to ED around 1300. Blood pressure was 207/100, chest x-ray and EKG negative. Patient also received albuterol puffs various times. She was monitored for almost 2.5 hours prior to being discharged to home.
Patient received a flu shot on 9/22/17 at approximately 10am. She began to feel ill the next day. On 9/26 she came to the office with headache-for 4 days on top of head and behind eyes; worse at night. She was diagnosed with acute non-intractable tension headache. NSAID and FLEXERIL were prescribed. On 9/28 the headaches worsened to severe. Patient was seen in the ER and given IV fluid, MOTRIN and BENADRYL (per the husband). She was released home. The next morning patient was not responsive, not alert to person place or time at home and an ambulance was called. She was hospitalized at hospital in the Infectious Disease ward (per the husband). He stated that many tests were performed. High dose steroids and antibiotics were prescribed and slow recovery occurred over 7 days. The patient was recently released from the hospital and is following up with a neurologist. The discharge papers stated the diagnosis was autoimmune encephalitis related to vaccination.
Erthyema/ induration: L arm 40x35mm, R arm 50x45mm. 10/28/2009 MD records for 10/22/2009. Patient presents with areas of erythema and induration at vaccination sites. Tx: tylenol and warm compresses.
A friend's bad reaction, so weird; He had a pop/knot raised in the shot arm; the pain grew and grew/within a couple of hours he couldn't raise the arm/pain was great; Radiating up and down his spine/radiating up and down his head; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (A friend's bad reaction, so weird), VACCINATION SITE MASS (He had a pop/knot raised in the shot arm), PAIN IN EXTREMITY (the pain grew and grew/within a couple of hours he couldn't raise the arm/pain was great) and PAIN (Radiating up and down his spine/radiating up and down his head) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L020A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 15-Jan-2021 to 21-Jan-2021.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (A friend's bad reaction, so weird), VACCINATION SITE MASS (He had a pop/knot raised in the shot arm), PAIN IN EXTREMITY (the pain grew and grew/within a couple of hours he couldn't raise the arm/pain was great) and PAIN (Radiating up and down his spine/radiating up and down his head). The patient was treated with MELATONIN at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (A friend's bad reaction, so weird), VACCINATION SITE MASS (He had a pop/knot raised in the shot arm), PAIN IN EXTREMITY (the pain grew and grew/within a couple of hours he couldn't raise the arm/pain was great) and PAIN (Radiating up and down his spine/radiating up and down his head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 102 (High) heart rate was 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was reported.   No treatment information was reported.   This case was linked to MOD-2021-059391 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Secondary reporter information, Patient's medical history, Batch/Lot number of vaccine and treatment medicine were added.
Began with very severe fatigue that lasted from 15th through 18th; obvious bruising/redness that looked like someone had grabbed arm leaving prints - but they did not press hard when giving shot. Bruising hurt for about 3 days, then began itching by 19th. Took BENADRYL to relieve. Could not do anything but lie down on 15th, 17th and 18th; 19th finally felt normal except for itching on arm.
Patient received Moderna in February he missed his March appointment. He called the call center who informed him he needed to restart the series. He said in April it was his 1st dose so he received. Moderna when he came back for 2nd dose of Moderna it was explained to him he has received both doses. He was satisfied.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 03/26/2021, 04/23/2021, and 01/05/2022.  They tested positive for COVID-19 via antigen test on 02/03/2022 at the nursing home at which they were a resident. They died on 02/10/2022.
Heart was rapidly beating; Felt tightness in the chest; Tiredness; Chills; Head stuffed up; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 08Sep2021 (Lot number: 30130BA) at the age of 39 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Immune thrombocytopenic purpura" (unspecified if ongoing), notes: Immune Thrombocytopenic purpura (ITP) and "Psoriasis" (unspecified if ongoing). Concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 09Sep2021 at 08:00, outcome "recovering", described as "Heart was rapidly beating"; CHEST DISCOMFORT (non-serious) with onset 09Sep2021 at 08:00, outcome "recovering", described as "Felt tightness in the chest"; FATIGUE (non-serious) with onset 09Sep2021, outcome "unknown", described as "Tiredness"; CHILLS (non-serious) with onset 09Sep2021, outcome "unknown", described as "Chills"; HEAD DISCOMFORT (non-serious) with onset 09Sep2021, outcome "unknown", described as "Head stuffed up". Therapeutic measures were not taken as a result of heart rate increased, chest discomfort, fatigue, chills and head discomfort.  Additional Information: The patient had no known allergies to his awareness. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that the patient's heart was rapidly beating and felt tightness in the chest during the morning (09Sep2021). By the afternoon, the symptoms lessened but continued to have typical symptoms (tiredness, chills, head stuffed up). Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
RECEIVED 3RD PRE-EXPOSURE RABIES VACCINE ON 4/30/2009 (PT IS A VET STUDENT.)  2 DAYS LATER HAD NUMBNESS AND TINGLING IN LEFT ARM AND LEFT LEG.  WENT TO DOCTOR ELSWHERE 5/2/2009.  TODAY 5/4/2009 NUMBESS GONE BUT HAS SOME PAIN ON INSIDE OF FOOT AND MID-LOWER BACK.  NO WEAKNESS SEEN BY MD.  USE IBUPROFEN AS NEEDED. CONTINUES TO IMPROVE AS OF THIS DATE.
Information has been received from a physician concerning a 62 year old female patient with asthma, high blood pressure and no drug reactions/allergies who on 05-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously (dose and lot number not reported). Concomitant therapy included: unspecified "asthma medication" and unspecified "high blood pressure medication". It has been reported that on 06-JUN-2012 the patient had large, hot, swollen left arm, along with headaches since the ZOSTAVAX (Merck) was administered. There was no treatment given for an AE. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. No laboratory/diagnostic studies were performed. Additional information has been requested.
Gave patient Flu vaccine that was not ordered by a physician because the patient had gotten one a week ago and patient did not need two doses of FLUARIX this season.
Appendicitis resulting in appendectomy. Patient had nonstop vomiting for 2 days, nausea, lethargy, headache that started hours after the 2nd dose.  She was feeling great and healthy prior to the shot.
At 1100 patient started feeling lightheaded,  vitals were B/P 128/81, 97% on room air, HR 146 BPM. No other symptoms, denied SOB, difficulty breathing. At 1110 vitals were 122/81, 98% on room air, HR 132 BPM.  At 1117 her HR 111, 98% on room air, remained alert and oriented, light headedness had improved. Patient was concerned she would develop hives, because she had a history in the past of developing hive. Patient agreed to transfer to ER at 1125.