chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; Fatigue; felt achy the next day; flu-like symptoms (unwell, and had fever); flu-like symptoms (unwell, and had fever); flu-like symptoms (unwell, and had fever); feeling weak; sore arm, specifically on her right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 20Oct2021 (Lot number: EW0186) at the age of 74 years as dose 3 (booster) 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Heart issue" (ongoing), notes: it started a couple of years ago.; "Heart surgery", start date: Mar2021 (unspecified if ongoing), notes: she had heart surgery in March before the vaccine. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, when the patient was 74 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), MALAISE (non-serious), PYREXIA (non-serious) all with onset 20Oct2021, outcome "recovered with sequelae" (21Oct2021) and all described as "flu-like symptoms (unwell, and had fever)"; PAIN (non-serious) with onset 21Oct2021, outcome "recovering", described as "felt achy the next day"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "sore arm, specifically on her right arm"; ASTHENIA (non-serious) with onset 20Oct2021, outcome "recovering", described as "feeling weak"; FATIGUE (non-serious) with onset 21Oct2021, outcome "recovering", described as "Fatigue"; DYSPNOEA (non-serious) with onset 22Oct2021, outcome "recovered" (22Oct2021), described as "shortness of breath". Therapeutic measures were taken as a result of pain, pain in extremity.  Additional information: Patient received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine on Wednesday, 20Oct2021. Then that night, she developed flu-like symptoms (unwell, and had fever), and felt achy the next day. She said she had sore arm, specifically on her right arm. She said she was feeling weak as if she had the flu today. She also mentioned that she was already feeling better. She took Tylenol twice for being achy.  No follow-up attempts are possible. No further information is expected.
Client reports back on 6-18-2009, one day after receiving dose #3 of HPV, that she now has Knots on back of head that are tender to touch. No problems with previous HPVs. Instructed client to see PMD today and report back to health dept.
A report received from a health professional on 30Oct02, concerning approx 10 vaccinees who inadvertently received last years formulation of Fluvirin. From 28Oct02 to 30Oct02, 20-30 staff members were vaccinated with Fluvirin. After finishing the vaccination, a staff member noticed that one of the used vials was last years vaccine (2001-2002). The vial was discarded, thus the batch number is not available. There was insufficient information to determine the reporters causality assessment. Update 1 27Jan03: A report was received from a health care professional concerning a 50 year old female vaccinee who received expired influenza vaccine (brand unspecified) on an unspecified date. The vaccinee was subsequently revaccinated with this years influenza vaccination and experienced no adverse reaction. See ref: PJP200200635, PJP200300049, PJP200300050, PJP200300051, PJP200200052, PJP200300053.
Initial unsolicited report received from a pharmacist on 03-Nov-2016. This case involves a 68-year-old patient (gender not reported) who was vaccinated with FLUZONE HD via intramuscular route (batch number: UI703AA, expiry date: 08-May-2017; dose, dose in series not reported) at left deltoid on 03-Oct-2016. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On 16-Oct-2016, 13-day after vaccination, patient experienced tingling in fingertips and diagnosed with Guillain Barre Syndrome. Patient was hospitalized on an unknown date. Patient required ER/doctor visit on 20 Oct 2016. Lab data and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none. Sender's Comments: GBS was suspected in this case after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, however diagnosis was not confirmed. Time to onset (13 Days) is compatible with a role of the vaccine. GBS is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. To be noted that GBS is often preceded by an gastrointestinal or respiratory infection which was not ruled out in this case. Details regarding relevant medical history, as well as infectious work-up and information on infections occurring prior to vaccination are needed for complete assessment of the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
which was worse after doses 3 and 4; Tachycardia (HR of 120 - 140 bpm for 12 hours); Product use for unapproved combination; off label use; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses, Dose 1), for Covid-19 immunization, reaction(s): "Tachycardia"; Bnt162b2 (Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses, Dose 2), for Covid-19 immunization, reaction(s): "Tachycardia". The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 13Nov2021, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 13Nov2021, outcome "unknown"; TACHYCARDIA (non-serious) with onset 14Nov2021, outcome "recovered", described as "Tachycardia (HR of 120 - 140 bpm for 12 hours)"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "which was worse after doses 3 and 4". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.  Additional information: Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses of the Pfizer covid-19 vaccine, which was worse after doses 3 and 4. I had the flu shot on the same day as dose 3 in Nov2021. I had the flu shot 01Sep2022, 16 days before I had dose 4 of the Pfizer covid vaccine (17Sep2022) and had tachycardia that was worse (more rapid HR and lasted longer) than after dose 3. The patient received Other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Needle leaked during administration; one dose on 7Oct2022, second one on 10Oct2022, twice leaked; Needle leaked during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number j39g3, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 10th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On 10th October 2022, the patient experienced incomplete dose administered and drug dose administration interval too short. On an unknown date, the outcome of the incomplete dose administered, incomplete dose administered and drug dose administration interval too short were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: The pharmacist reported that the patient was administrated with Flulaval QIV and the needle was leaked.  Adverse event was not reported. Twice the vaccine was leaked. The pharmacist thinks it was because of a problem with the needle gauge.  They were using 25g instead of 21g and 23Gg. The patient's identifiers was not provided The reporter consented to follow up. Additional Supportive Information: The patient was administrated with Flulaval QIV twice and the needle was leaked, which led to incomplete dose administered. The patient received 2nd dose of Flulaval QIV earlier than recommended interval, which led to shortening of vaccine schedule. The case was linked with case US2022146210 reported by same reporter for different patient. As it was not clear that 10th October 2022 dose was replacement or not therefore it was considered as 2nd dose and event drug dose administration interval too long was coded along with incomplete dose administered as it was stated that twice the vaccine was leaked.; Sender's Comments:  US-GSK-US2022146210:Same reporter
Patient was given second shingles immunization and Prevnar 20 immunization on 9/27/22. A few days later 10/1/22 he came to pharmacy complaning of pain in deltoid region of arm that radiates down arm and fells like a sharp stabbing pain(nerve pain). "Patient stated that he is not sure if a nerve was hit when injections were given." Pain started to get worse a day after injections and pain is very strong when it happens. Pain is intermintent at times. Patient said tylenol and hydrocodone/apap does not help with pain. He wanted the incident documented.
1707 patient sat down in monitoring area after vaccination.  1737 patient left after 30 minutes of monitoring (was being monitored for half an hour due to Zithromax allergy that results in itching and rash) 1750 patient came back to monitoring area reporting tingling in left face, left arm, and left leg. Vital signs taken by LPN. BP 171/91. O2 sat 100% on Room Air. Pulse 70. Respirations 19.  1753 Ate 2 graham crackers and drank 711 ml of water. 1754 Vaccine Clinic Team Lead RN made aware of patient reporting symptoms. 1756 patient reported worsening tingling to bilateral arms, legs, and back of head. 1757 Code called. 1800 patient taken to ER in wheelchair by Emergency Room RN. Nursing Supervisor present.
Child developed fussiness around stooling immediately after exam and decreased po intake immediately after 4 month vaccines/4 month well child exam.  He was seen in clinic a few times for this and was told he had a viral illness.  No fever, no vomiting, no rash, no diarrhea, stooling normally, no rhinorrhea, no cough. He had a normal CBC, negative blood and urine cultures. The fussiness and anorexia resolved about 7- days after vaccines.  9 days after 4 mo vaccines the patient developed strabismus with bilateral CN VI palsies that are improving with patching prescribed by ophthalmology.  Brain MRI with and without contrast was normal.
I visited Hospital after noticing a reaction to the covid shot. The left side of my face including my eye, cheek and lips felt swollen and numb. I also had the chills.  The doctor was unable to give me any information  related to my reaction from the vaccine and recommended I take Tylenol. However this reaction persisted for the past four days. The swelling has subsided.
Flushed. full, chapped lips, sore throat, itchy eyes. hives on chest and torso. 10/7/14 resolved slowly over the course of the week.
Information has been received from a physician concerning a 74 year old male who on 10/11/99 was vaccinated. On 10/11/99, post vax, the pt experienced paresthesia (numbness) of right arm from site of injection down to the fingers. Upon medical review, the pt's condition was considered an 'important medical event.' Follow-up information received, indicated that the pt was seen at the clinic following his CT scan and was much improved. The physician believed that his condition was complicated by the fact that the pt had experienced a stroke on the same side. No further details were provided.
soreness at the injection point; did not mix the 2 vials  before administering the vaccine; did not mix the 2 vials before administering the vaccine; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter did not mix the 2 vials for the shingrix vaccine before administering the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient had soreness at the injection point. The reporter consented to follow up.
Facial numbness  Lax forehead  Drooping eyes Severe site pain  Tingling face
Pt developed diarrhea 4 days after vaccine which is still continuing (12 days after vaccine), developed temperature of 103.5-104 degrees 7 days after vaccine for 2 days, deveopled red spots all over body 10 days after vaccine (spots still present at 12 days), no treatment provide by md besides tylenol and motrin. Vaccination given on 9/19/05.
Sore, painful, about 40 in. in diameter, red, swollen, itchy
Patient received vaccines at approximately 1800 6/15/17. Approx. 1.5 hrs after (1940) he developed a rash which started on face and hands. The rash progressed overnight - at 10:30 (6/16) became hives/swelling over entire body.
Patient woke up confused, febrile (102.7), and tachycardic. Patient received tylenol and IV fluids. Patient was observed and discharged to residing Nursing Home.
The patient was given the Pfizer bivalent booster as her 1st covid vaccine instead the Pfizer monovalent for her 1st covid vaccine
INTENSE pain left side under arm, down around left backside, left breast, numbness in fingers, weakness in left arm, inability to use left arm and left hand for over two months.   Spasms would come and go that were so intense that it left me almost fully incapacitated coping with the pain that accompanied them.  The pain was almost non-stop keeping me awake unable to navigate my days either.   Currently, in the end of July, I almost have full feeling back in my left hand fingers but still experience intermittent spasms that are less intense and painful n my left breast, under my left arm and the site of the injection.
Presented first to a rural community hospital with 3 days of left greater than right lower extremity weakness and numbness that had progressed to the point of her inability to walk. At the rural hospital MRI indicated she had multiple intracranial lesions concerning as the etiology of her new paresthesias and weakness. She was transferred to  Medical Center for assistance obtaining a lumbar puncture where MRI redemonstrated the concerning findings, first thought to be CNS lymphoma. After extensive progression of the disease (profound weakness equating paralysis to the level of the neck) and extensive  work up including brain biopsy, it was determined she had Acute disseminated encephalomyelitis (ADEM).
Left upper arm swollen, red, itchy c/w allergic reaction to pertussis vaccine.
mom says apneic monitor went off & read heart fast-said pt was completely blue & stiff;mom put pt on floor-gave 2 breaths in mouth & felt no P; pt responded w/movement & called amb
Patient was given three vaccinations at the same time. Adacel and flu administered on one arm and pneu 23 on the other arm. Patient reported chills and pain. Once admitted elevated WBCs. Patient is out the hospital and doing much better.
a horrible headache, which lasted for about 36 hours and sleeplessness  legs felt like they weighed 200 lbs and felt like i was carrying weight on my back..  e
administered a non-diluted dose of Pfizer 5?11-year-old bivalent to the patient prior to realizing the vaccine had not been diluted properly
Employee received shot on 1/8/2021; stated that she was not feeling well all weekend; she just felt off. This morning (1/11/2021) employee reported extremely dizzy. Employee went home.
Received 4 Prevnar vaccines as proscribed, 06/15/04, 08/13/04, 10/22/04 and 04/13/05, had invasive Pneumococcal DX. These vaccines were vaccines for children (program), some power loss during hurricane but not deemed replaceable by VFC. Discharge summary states latex allergy developed. msv Medical records states Upper respiratory infection, febrile seiaure, vomiting, hypoxic. msv
1800 TIRED, FATIGUE MUSCLE ACHE. 1/27/2021 0700 SORE/SWOLLEN AT INJECTION SITE. SORE ARM AND FATIGUE RESOLVED ON 4TH DAY Narrative:
Dizziness a few hours after shot. On Friday (04/16/21), I woke up with vertigo and extreme dizziness.
Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications  was reported . No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up appended
Asthma; fFtigue; Bedridden; Could not lift her arm; Arm was so sore at the injection site; Chills; Aches/ Pain; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bedridden), ASTHMA (Asthma), LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site), CHILLS (Chills), MYALGIA (Aches/ Pain) and ARTHRALGIA (Sore arm). On 20-Apr-2021, the patient experienced BEDRIDDEN (Bedridden). On 23-Apr-2021, the patient experienced FATIGUE (fFtigue). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHMA (Asthma). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (Bedridden), ASTHMA (Asthma), LIMB DISCOMFORT (Could not lift her arm), VACCINATION SITE PAIN (Arm was so sore at the injection site), CHILLS (Chills), MYALGIA (Aches/ Pain), ARTHRALGIA (Sore arm) and FATIGUE (fFtigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  It was reported that patient was on several medications after diagnosed with asthma. Patient stated that she cancelled her second shot.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-May-2021 contains significant information: added  medical history and new events.
LOCALIZED REDNESS; SWELLING (90mm x 152mm area of induration)@ Rt posterior arm; FEVER UP TO 103.5; NAUSEA; SEVERE HEADACHE; GENERALIZED FATIGUE.
Redness and warmth approx 2 inches diam below and spreading medial to vaccination site.
This case was received from a consumer on 03 June 2008.  A 26-year-old female patient, with no medical history, received a first injection of FLUZONE (lot number U1128AA) on 15 November 2003.  In December 2003, the patient reported feeling unwell.  On 02 December 2003, she experienced a fever of 102 degrees.  Subsequent laboratory testing revealed elevated liver enzymes; per the patient, her blood work was "all off".  A liver biopsy was negative for "auto immune attacks", and a bone marrow biopsy was negative for leukemia and lymphoma.  According to the reporter, the event had resulted in prolongation of hospitalization.  The event had not yet resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; AMITRIPTYLINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: positive tests (antigen self-test); (29Dec2022) Positive, notes: Still testing (antigen self-test) positive on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201401259 Same reporter/patient, same drug/different dose, different AE;
Radiating pain, most bothersome at night, sometimes feels in his forearm and ring finger, first noticed about a week after vaccination.
Shingles Diagnosis, itchy rash on right side of neck and both forearms, no nerve pain to date.   Prescribed Valtrex: 1gm, Triamcinolne .01% Cream, Sarna OTC lotion to relieve itching, benedryl gel to relieve itching