chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Monitored client for 15 minutes after vaccination administration.  Client reported she was feeling well.  No adverse reactions noted.  She was released back to her job duties.  Client called front desk receptionist at approximately 11:15 AM.  She stated that she was feeling dizzy, weird, and not ?feeling right?  Front desk receptionist informed me of client?s status.  I went to assess client and she was laying back.  She stated that she felt like she was going to pass out.  I had her put her head in-between her legs with a cool rag behind her neck.  The overhead lights were turned off and the room dimmed.  She stated that she started to feel better but felt pressure in her head, her nose, and tingling in her ears.  She stated that she had breakfast but had not taken her blood pressure pills.  Wheat Thins and water given to her.  She tolerated it well.  At 11:25 her blood pressure was obtained and was 163/98.  She took her prescribed 20 mg Lisinopril and 1000mg of Tylenol.  Continued monitoring client and reassessed blood pressure at 11:40 AM and was 151/88.  Client ambulated with assistance back to clinic.  She was advised to lay down with lights off.  Client rested for approximately 35 minutes, ambulated to restroom and back to room.  Blood pressure reassessed and was 195/91.  Client education given on the risks for heart disease and other complications due to extremely high blood pressure.  Client was immediately referred to her PCP for follow-up. Client verbalized understanding and said she would have another employee follow her to her PCP. It was reiterated again the importance of going immediately, to ask for a cardiac referral because of extensive family history of heart disease. She was also advised to ask her PCP about her current blood pressure medication; however, she explained that her ?PCP had just recently changed her blood pressure medication about 2 weeks ago?. Client was able to ambulate back to her desk to pick up her belongings and left the building with another employee accompanying her. A follow-up phone call was made at 1502 and client stated that ?she went to her doctor, and they made a referral for a cardiologist, they gave me a shot to help lower my blood pressure and it helped?. She was asked about her blood pressure at her PCP, she stated ?the top number was 172, and after the shot was given the top number was 153. Client stated she was feeling better and was resting. A follow-up call will be made 9/11/2020 to check on her status.
Unsure if patient had CKD prior to receiving Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of chronic kidney disease in a elderly female patient who received Herpes zoster (Shingrix) (batch number 477Z7, expiry date 7th December 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chronic kidney disease (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the chronic kidney disease was unknown.   It was unknown if the reporter considered the chronic kidney disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. It was reported that the patient started dialysis after 1st dose of Shingrix, and the patient was in the hospital for unknown reason.  He was unsure if patient had chronic kidney disease (CKD) prior to receiving Shingrix. The batch number of Shingrix was reported as 47727, but it was changed to 477Z7 as per sales data sheet. The reporter consented to follow up.
Pt got vaccine on Friday evening and by Sunday morning he had developed a ringing in both ears, He describes it as a constant buzzing, humming, ringing sound. It is very bothereome when he is trying to rest at night.
Stomach Cramping Vomiting Diarrhea Nausea Body Weakness Chills Sweating profusely without a fever
2 hrs p/vax pt had screaming episodes; mom describes pt as uncontrollable & unable to be comforted in any manner; had rash-no other s/s;
Patient described original "tenderness" after shot, then went away. Approx. 2-3 weeks later pt felt that arm where shot was given was lame and had decreased mobility but without tenderness. Resolved all symptoms over the next 2 days. No tenderness, redness, rash or trouble breathing reported.
swelling in my neck threatening ability to breathe   as well as in ankle and face      the threat to breathing most alarming to me  and with all my allergies I have not gone back for second shot
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Hoarse Voice; I still have the red dot like a mark from the first Vaccine but he refers that it was from the Jynneos; second one already disappeared with left a little blueish; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; smallpox vaccine live (mav-bn) (JYNNEOS), on 12Jan2023 as dose 1, single (Lot number: FDP00018) for monkeypox, prophylaxis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DYSPHONIA (non-serious), outcome "not recovered", described as "Hoarse Voice"; VACCINATION SITE MACULE (non-serious), outcome "not recovered", described as "I still have the red dot like a mark from the first Vaccine but he refers that it was from the Jynneos; second one already disappeared with left a little blueish". Therapeutic measures were not taken as a result of dysphonia, vaccination site macule.  Additional information: Patient reported some adverse reaction on one of our vaccines but also mentioned that he had the COVID-19 Booster (Clarified as Pfizer COVID-19 Vaccine Booster). The patient had the COVID-19 Booster on 12Jan2023, and also had the first dose of the Jynneos Vaccine for the Monkeypox of Prophylaxis it on the same day. Patient had second shot of Jynneos on this Friday and started with this Hoarse Voice as possibly had noticed already, as the first dose was 4 weeks ago and one day noticed it together and  had it together with the COVID-19 Booster Vaccine from Pfizer. Patient still had the red dot like a mark from the first Vaccine but refers that it was from the Jynneos and the second one already disappeared with left a little blueish, but the first one's mark was still there. No fever but Hoarseness was getting worse. Patient did not feel sick, and also mentioned, not even considered a risk with the Monkeypox Vaccine but had it as patient was about to start a Biologic drug.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Pfizer vaccine (COMIRNATY) and wa admitted a week later with acute lung rejection and was attributed to antibody mediated rejection. Patient deteriorated rapidly requiring intubation, mechanical ventilation and ECMO and passed away eventually
pt recvd vax & w/in a few hrs p/vax pt exp red rash extending 4 inches from the inj site down arm;
After the second vaccination, The first injection site became red like a bee sting. Both injection sites are red but the first one is now larger and red AFTER the second injection.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 6 months old infant patient of unknown gender. On 25-JUN-2014 the 17 month old patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot # J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Nausea, muscle pain, body aches, fatigue, headache, and chills.
Awoke day after receiving vaccine with swollen eyelids (1/2 closed), blotchy red flat rash-volar surface of wrists 3 inches in length.
Redness edema, pain - administered into back of right arm into subcutaneous fat tissue. Duration 4 days.
Uncontrollable crying - temp 103-lst day baby seen by MD 2FEB91 felt sx were related to sore throat & not immun. MD reported as ADR on 22FEB91. Seen in Hlth Dept on 25FEB91 appears to be well & happy.
On 02/02/2023 I was experiencing chills, slightly runny nose and sore throat. I began with a fever, nasal congestion, fatigue loss sense of smell and headache continuing to the next day. Symptoms lasted about a week.
Imm given 6/26/15 at 9:00 AM. Mom states (L) arm had a "little red dot". 6/28/15 mom states child "ran into something" and the area became very red and warm and had a "huge knot". Took to ER was told it was allergic reaction to vaccine.
Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zpak, reaction(s): "Drug Allergy", notes: Known allergies: zpak. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Covid test resultPositive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: covid test type post vaccination other.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored ROTATEQ (lot # M041181 with expiration date 31-MAY-2018, oral; dose was unknown, for prophylaxis) which were exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA010405: US-009507513-1708USA010404: US-009507513-1708USA010242: US-009507513-1708USA010406: US-009507513-1708USA010407:
HCP reporting improperly stored VARIVAX was administered to 2 patients on 26SEP2022. No additional details provided. See additional AE 02256046. No PQC.         ?    Names of vaccines involved VARIVAX (Lot: W003818, Expiration Date: 2FEB2024); This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient.s pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 26-SEP-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 milliliters once as prophylaxis (lot number: W003818, which was determined to be valid, with an expiration date on 02-FEB-2024) (route and anatomical location of administration were not reported) (product storage error). The administered dose underwent a temperature excursion of 25.1 degrees Fahrenheit (F) for 4 hours and 45 minutes. It was reported there was not any previous temperature excursion. No additional adverse event was reported.   This case is one of two reports form the same reporter.; Sender's Comments:  US-009507513-2209USA010432:
WOKE UP THAT NIGHT SICK TO HER STOMACH. ARM SORE IN A 3 INCH BAND AROUND. WAS FEELING WELL ENOUGH THE NEXT DAY (SUNDAY) TO GO TO FOOTBALL GAME & WAS RECOVERED BY TUESDAY.
No additional adverse events reported; PROQUAD was administered on 05MAY2021 that expired on 02MAY2021; This spontaneous report as received from a pharmacist and medical assistant concerning  a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.   The pharmacist and Medical assistant reported that on 05-MAY-2021, the patient was vaccinated with an expired  dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S035111, expiration date reported as 02-MAY-2021 but upon internal validation established as 03-MAY-2021), dose:0.5 milliliter for prophylaxis (dose number was not reported).    Concomitant therapies included sterile diluent (STERILE DILUENT).     The Medical assistant reported that the patient denied further adverse event or temperature excursion with the vaccine. No product quality complaint. No additional adverse event details. No additional adverse events reported
Aches, chills, fever of 101. Generally felt terrible the entire day August 17th after 3rd Moderna shot on August 16th. Fever brought down by tylenol, but I hardly ever run a fever, so 101 was very high for me.
Client felt disoriented and legs weak. 2-3 minutes after his observation period, as he was walking out.  His vitals at 1435, O2 -97, HR - 84, BP, 122/90. Client was cleared at 1445.
urticaria reaction; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves female patient of unknown age who experienced urticaria reaction, while she received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [Quadracel] and INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U1847AB, expiry date: 30-Jun-2018 via unknown route. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5248AA, expiry date: 21-Aug-2018  via unknown route in unknown administration site.  On 20-Mar-2018, unknown latency after receiving of  INFLUENZA QUADRIVAL A-B VACCINE and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, the patient developed a non-serious urticaria reaction (urticaria).  Lab data was not reported.  Final diagnosis was Mild urticaria reaction.   It was not reported if the patient received a corrective treatment.  The outcome of event was not reported.  List of documents held by sender: none.
Client received her first dose of the Pfizer vaccine. She stated that she was allergic to alcohol and bleach. During her 30minute post-vaccination wait time, she complained of tightness in her chest and attributed it to the smell of alcohol (from the alcohol pads) in the cafeteria. She was evaluated by Nurses, the EMT Personnel working at the POD. She wanted to know if she could use her inhaler, since she was asthmatic. She used her inhaler, stated she felt fine and was observed for another 15 minutes, during which period she denied any symptoms.
I got sharp ear pain when I went to bed around 9pm on 2-2-23. It woke me up causing me not to hear anything out of the right ear and not sleep majority of the night. Since 2-2-23 to now 2-10-23 I can't hear out of the left ear and its ringing currently as 2-10-23
dull pain in heart twice, didnt last long, got up and moved around/drank water pain went away
Pain in arm that injection was administered from neck to the wrist; warm at injection site and slightly swollen.
headache; fever; chivering; pain in joints; got very little sleep; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 16th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache, fever, shivering, joint pain and sleeplessness. On an unknown date, the outcome of the headache, fever, shivering, joint pain and sleeplessness were unknown.   It was unknown if the reporter considered the headache, fever, shivering, joint pain and sleeplessness to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The reporter stated that the patient had got very little sleep, suffered from headache, fever, shivering and pain in joints after vaccination. The reporter stated that the patient had fibromyalgia but was not on immune suppressing drugs. The reporter asked what patient can do to reduce or treat the side effects.
Swelling, itching, burning and inflammation of right arm at body site. Currently symptoms are being treated with Benadryl and icing at body site, doctor visit if symptoms do not improve or worsen within a few days.
Slight puffiness on her left cheek; Swollen lymph nodes; Light tightness in her throat; Her lymph nodes remain just a little tender but are no longer swollen; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), via an unspecified route of administration in arm left on 14May2021 08:00 at single dose for COVID-19 immunisation. Medical history included triple coronary artery bypass graft (CABG) on 20Apr2019, and deep vein thrombosis (DVT) and pulmonary embolism (PE) blood clots following a surgery 2 years before. Concomitant medications included simvastatin taking for a year and a half at 100 mg one time per day for blood cholesterol, fenofibrate taking for years at 145 mg tablet one time a day by mouth for blood cholesterol, apixaban (ELIQUIS) at 5 mg tablet twice a day by mouth for blood clots from 20Apr2019, alendronate sodium (FOSAMAX) taking for about 6 months or so at 35 mg one tablet on Mondays for bone density abnormal, eicosapentaenoic acid ethyl ester (VASCEPA) at 1VM capsule, 2 capsules in the morning and 2 capsules at night, and a lot of vitamins taking for years. The patient experienced a slight puffiness on her left cheek, very swollen lymph nodes, and light tightness in her throat when she woke up on 15May2021. She said she took diphenhydramine hydrochloride (BENADRYL) which helped make her feel better. She thought she only had a mild reaction since she did not feel the need to call (with held). Patient wanted to know if she should still receive the 2nd dose based on the reaction she had with the 1st dose. They told her if she had a reaction she would have within a few minutes or an hour of getting the vaccine, she was just different, she would have reactions to some things the next day. Within a day the lymph nodes went down and she felt like it had cleared up, her lymph nodes remained just a little tender but were no longer swollen. Outcome of the events was resolving.
Mom reports child became "sleepy and fussy" five minutes after receiving vaccines. Child taken 10/4/02 to ER. Sleepy, inconsolable crying x 12 hrs, vomiting.
Sharp electric shooting pains (left side/brain); Flue like symptoms; Feelings of blockage that sends semi-sharp pain to left shoulder; Brain surges/headache; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ELECTRIC SHOCK SENSATION (Sharp electric shooting pains (left side/brain)), INFLUENZA LIKE ILLNESS (Flue like symptoms), ARTHRALGIA (Feelings of blockage that sends semi-sharp pain to left shoulder), HEADACHE (Brain surges/headache) and INJECTION SITE PAIN (Soreness at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21A) for an unknown indication.     The patient's past medical history included Osteoarthritis in 1990. Previously administered products included for an unreported indication: METHYLPREDNISOLONE (methylprednisolone 40mg right knee joint.) on 26-Mar-2021.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ELECTRIC SHOCK SENSATION (Sharp electric shooting pains (left side/brain)), INFLUENZA LIKE ILLNESS (Flue like symptoms), ARTHRALGIA (Feelings of blockage that sends semi-sharp pain to left shoulder), HEADACHE (Brain surges/headache) and INJECTION SITE PAIN (Soreness at the injection site). On 29-Apr-2021, ELECTRIC SHOCK SENSATION (Sharp electric shooting pains (left side/brain)) had resolved, INFLUENZA LIKE ILLNESS (Flue like symptoms) and ARTHRALGIA (Feelings of blockage that sends semi-sharp pain to left shoulder) outcome was unknown. At the time of the report, HEADACHE (Brain surges/headache) and INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable Hospital cardiology testing results showed: __ LBBB (left branch bundle blockage). __ Blunted systolic BP response to exercise (treadmill & nuclear-drug induced).
large red patch 4in long 2 inches wide (approx.) somewhat itchy, hot to touch.
The patient was given a second Bivalent Booster within a month of recieving her last Bivalent booster.  The patient received a Bivalent COVID Booster on 09/22/22. She then presented to the clinic yesterday to get a Bivalent COVID booster even though it was administered already on 09/22/22. The vaccine card that she presented only showed that she was vaccinated last on 04/27/22. She did not have an adverse event, but this was an error that needed to be documented as she got another bivalent booster when she wasnt due for it.
Pt experienced a fever of 102.4 - 102/6 for 2 days. Pt started on 2/20/00. Fever was decreased on 2/23/00. Rash developed on 2/23/00, rash was fine erythema no raised areas, covered entire body, face flushed, child has thick yellow-green nasal drainage for 3-4 days and poor appetite.