chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certificate medical assistant referring to an unspecified number of patients of unknown age and gender. Medical history, concomitant medications and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (dosage and route of administration were not provided; lot number M00986 expiration 26-MAY-2017). No adverse effects were reported. The administered vaccines experienced a temperature excursion of 15degreesC for 9 hours on an unspecified date. Data logger was not involved. Previous temperature excursion was 0degreesC for 24 hours on an unspecified date. A product quality complain was not involved. This is one of three reports from the same source. Additional information has been requested.
about 1930 hrs pt started itching all over body & about 2130 hrs went to ER to ask if maybe it was a reaction; had splotchy rash all over arms & chest area; was given 3 shots to conteract reaction;
p/vax pt got diarrhea 6 to 7 times/day for about 2wk;pt given special formula (Isomil DF)it didn't help;
While patient was seated in the post-vaccination  observation area, she noted dizziness onset 10 min post-vaccination and reported to clinic personnel, RPh discussed with patient. Just prior to speaking with the patient, the patient stated she took ibuprofen 200mg. No other symptoms or signs noted by patient. Patient stated she had never experienced similar symptoms post-vaccination but that she had fainted once before many year ago unrelated to vaccines. Patient recovered and departed around 12:30pm.
Jan 30 evening  experienced Dizziness,  Room spinning  went to bed  Jan 31. Woke up dizziness waited awhile and got up seemed to go away Feb 01,  woke up and felt dizzy moving about, completed morning routine  still dizzy went to kitchen   and stumbled and ran into refrigerator. Sat down but every time I got up felt room spinning. Called primary physician and reported symptoms to office personnel. Physician returned call and described above symptoms. Advised to report side effects to the agency, would send meds for vertigo and drink plenty of water.
had been given only the liquid portion; had been given only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 6th August 2021, the patient received Menveo. On 6th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that a patient was given only the liquid portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No patient data was provided by reporter aside from age, which was mentioned casually.  The reporter did not consent to follow-up.
Chills; cough; fever of 100.5; sore arm that has a bump; sore arm that has a bump; itches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Feb2022 14:45 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "chronic hives" (unspecified if ongoing); "chronic dry skin" (unspecified if ongoing); "Known allergies: Corn" (unspecified if ongoing); "Known allergies: lettuce" (unspecified if ongoing); "Known allergies: milk" (unspecified if ongoing); "Known allergies: any and all penicillins" (unspecified if ongoing); "Known allergies: cephalasporins" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; HYDROXYZINE; MELATONIN; PREDNISONE. Past drug history included: Morphine, reaction(s): "Known allergies: morphine"; Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Topamax, reaction(s): "Known allergies: Topamax"; Meloxicam, reaction(s): "Known allergies: melaxicam". Vaccination history included: Bnt162b2 (Dose number: 1, Prev dose product: COVID 19, Prev dose brand: BioNPfizer, Prev dose administration date: 11Jan2022, Prev dose administration time: 03:00 PM, Prev dose vaccine location: Left arm), administration date: 11Jan2022, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "Chills"; COUGH (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "cough"; PYREXIA (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "fever of 100.5"; PAIN IN EXTREMITY (non-serious), MASS (non-serious) all with onset 10Feb2022 02:30, outcome "recovering" and all described as "sore arm that has a bump"; PRURITUS (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "itches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, cough, pyrexia, pain in extremity, mass, pruritus.  Additional information: The Facility type vaccine was Workplace clinic. The patient had no other vaccine in four weeks. She did not had covid prior vaccination. She was not covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Macular papular rash on chest, collar area and upper arm, at deltoid area.
01/11/2022 @ drive though site  On-site medic at the time in incident. Responded to 41 yr. old female w/ CC of "confusion. dizziness, and tired." Driver of the vehicle reports that the patient past out in the car w/ LOC before parking the car. Pt denies headache, dizziness, blurred vision, vomiting, difficulty breathing, recreational drugs, or recent illness. Pt is able communicate and responds appropriately to questions. A/O X 4.  V/S: RR-12, SAo2- 96, HR-54, BP-120/60, CTM- pale, cool. and dry. Cap refill- <2 seconds PMH: Epilepsy, Rx Meds- Trazadone, Allergies- NKDA, last oral intake was yesterday.  Physical Assessment- airway patent, breathing regular/slow/shallow/and without effort. Circulation- skin: cyanotic, warm, dry, pale. Pule- radial, slow, regular, weak  Ambulance arrived at 1304. Patient placed in trendelenburg in passenger seat. Vitals reassess and within normal limits. EMS conducted by Site Lead-to paramedic-  for follow on care to higher eschelon.
Simplex Keratitis; Condition aggravated; This case was reported by a physician via call center representative and described the occurrence of herpes simplex keratitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (developed zoster about 6 months ago). Concurrent medical conditions included herpes simplex keratitis (suffering from bouts of simplex keratitis for 6 months).   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced herpes simplex keratitis (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the herpes simplex keratitis and condition aggravated were unknown.   The reporter considered the herpes simplex keratitis and condition aggravated to be unrelated to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but it could be 59 or 60 years. About a week before the reporting date, the patient received Shingrix. The patient experienced bout of simplex keratitis. The physician wanted to put the patient on Acyclovir. The physician did not believed the simplex keratitis was related to Shingrix given her history. No lot or expiration date or information regarding administration of Shingrix was available. The reporter consented to follow up.
Vaccine administered 6/25 around 6:30 pm. Pt called 6/27 to state injection site is red, swollen and hot to the touch. She noted she got along bite near injection site which had been scratched.
Information has been received from a physician concerning a 19 year old female who on 27-JUL-2007 was vaccinated at her family practitioner with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ethinyl estradiol/mestranol/norethindron (ORTHO-NOVUM). Immediately after being vaccinated with the first dose, she experienced headache and blurred vision and did not seek medical attention. The patient "recovered from that" and was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) on 19-OCT-2007 at her OB/Gyn office (her family doctor ran out of the vaccine) and was "feeling fine". There was no illness reported at the time of vaccinations. Two days later, on 21-OCT-2007, the patient called her OB/Gyn office because she was experiencing headache, blurred vision, numbness in her face and bilateral numbness in her lower extremities. No laboratory/diagnostic tests were performed. The physician reported that they will not administer the third dose. The patient "just didn't feel right" and the patient's headache, blurred vision, numbness in her face and bilateral numbness in her lower extremities persisted. Additional information has been requested.
Pt had syncope/vagal response after GARDISIL #3 and ADACEL. I was in the room with pt. as she was in mid sentence saying "she felt funny". Pt sitting on exam table and laid down about 20-30 sec returned to NL. Alert and oriented x 2. BP WNL. Pt without breakfast. Pt waited 20 minutes and was with nl exam- left office d/t finished. Pt states she passes out with shots.
Swelling of upper and lower lips.  Took 25 mg diphenhydramine.
This spontaneous report was received from a registered nurse and refers to a 12-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
I could not open my eyes; associated with Mild flushed; EPISODIC Parosymal Hypertension/hypertensive episode lasted for 5 hours to 7hours per day/ highest BP at home was 216/95 mmhg/ episode of Paroxysmal hypertensive episode associated with tachycardia.; I developed a continuous tearing & watery nasal dripping that lasted for 7 hours; episode associated with tachycardia; I developed a continuous tearing & watery nasal dripping that lasted for 7 hours; I was not feeling well; This is a spontaneous report from a contactable physician (patient). A 71-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 25Feb2021 10:00 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included thyroid cancer, hypertension, Sjogren's syndrome, hyperlipidaemia. Concomitant medication included amlodipine, aspirin, atorvastatin calcium (ATORVAS). No other vaccine was received in four weeks. No covid prior vaccination. The patient previously took lisinopril and experienced allergy (caused cough). The patient underwent COVID test  via nasal swab post vaccination on 08Mar2021 and result was negative. 2 days after receiving vaccine on 27Feb2021, the patient developed a continuous tearing and watery nasal dripping that lasted for 7 hours. At that time, the patient could not open eyes and the patient was not feeling well. and then one and off episode of paroxysmal hypertensive episode associated with tachycardia. Highest BP at home was 216/95 mmHg and worsening PR was 126/4min. Associated with mild flushed but not associated with clammy, no dyspnea, no nausea or vomiting, no diarrhea, no right side abdominal pain. This hypertensive episode lasted for 5 hours to 7 hours per day. The patient contacted to primary care doctor twice in different days. The patient was brought to ER where the patient got first Pfizer shot. Stayed one night 5 as observation patient on 08Mar2021 and next day 09Mar2021, the patient was admitted to Medicine floor. During hopitalization, this episodic parosymal hypertension was continued SBP was up to 211 and finally discharged from hospital on 21Mar2021. The events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event. Extensive work up was done. No treatment was received for events. The outcome of events was recovering.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available.
Case number PHEH2014US021342, is an initial spontaneous report received from pharmacist on 21 Oct 2014 with a follow up information received from a pharmacist on 22 Jan 2015. This report refers to a 61 years old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of FLUVIRIN (batch number: not reported) which were tolerated in the past. She was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly at a dose of 0.5 ml on 07 Oct 2014. On an unspecified date post vaccination she complained that she could not raise arm over her head and she had bad pain in her shoulder and arm. The outcome of pain in shoulder and arm was reported as condition unchanged and that of could not raise arm over head was not reported. The events were reported as disabling. The causality assessment was not reported. No further information was provided. Follow up information received from a pharmacist on 22 Jan 2015: Updated patient demographics (initials, date of birth, age, height and weight), vaccination history, suspect vaccine, batch number, dose, route and date of vaccination, event (pain in shoulder and arm), outcome and seriousness.
The patient experienced a rash at the injection site, a welt the diameter of a grapefruit and very raised that itched and stung like a bee sting.
Instant elevated high blood pressure - 190/100 Dizziness Now suffer from incontrollable high blood pressure and also coronary vasospasm's.  I have been hospitalized several times and have constant chest pain.   Now also diagnosed with Coronary Microvascular Disease.
late for the 2nd dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that, the patient did not receive the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter did not have the lot and expiry date.  The reporter consented to follow-up via mail.
Pain, sensitivity, and heat where vaccine wad injected. Major pain in the muscle the following days, pain is in the muscle and spreading over my shoulder, the same amount of pain as if I pulled muscles or pinched a nerve, I cannot use my right arm.
My arm was hurting; It's not as bad but it's still red and swelling is still there; I have been having Temperature; Swelling and redness in my arm; Arm is still sore; Swelling in my arm in both areas at the injection site and in my lymph nodes; Swelling in my arm in both areas at the injection site and in my lymph nodes; Been very tired for last several days; My appetite is not normal; This is a spontaneous report from a contactable consumer or other non hcp.    A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via intramuscular route of administration, administered in Deltoid Left on 10Jun2021 09:40 (at the age of 68-year-old) as single dose for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing, Patient stated I am allergy type person with some medicines, I tend to have reactions from insect bites and different things like that, multiple allergies from an unknown date and unknown if ongoing. Concomitant medication included verapamil (Verapamil) taken for blood pressure measurement, start and stop date were not reported. The patient experienced swelling in my arm in both areas at the injection site and in my lymph nodes on 10Jun2021, patient stated been very tired for last several days and my appetite is not normal on Jun2021. Patient want to inquire How long would these last? Any recommendations on what to do? During the day on Thursday it was ok but later in the evening by Friday am at 3am I woke up and my arm was hurting. Patient stated It has lasted for 3 days now and it's not as bad but it's still red and swelling is still there. "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Patient stated "I just received my first COVID shot on Thursday. I have been having Temperature and swelling and redness in my arm it seems to be going away, but today the arm is still sore, it still feels warm on 10Jun2021. Date for Second COVID shot: Consumer stated "Supposed to get 01Jul2021.Therapeutic measures were taken with "Tylenol" as a result of the events swelling in my arm in both areas at the injection site and in my lymph nodes, been very tired for last several days, it's not as bad but it's still red and swelling is still there, i have been having temperature swelling and redness in my arm, arm is still sore. The patient underwent lab tests and procedures which included blood test: unknown on 08Jun2021. Outcome of event was unknown for event Swelling in my arm in both areas at the injection site and in my lymph nodes and for all events outcome was not recovered.
Pt recvd 3 doses of Hep B vax & blood work for HBSAG was neg; Pt recvd 2 Engerix-B booster doses on 18APR91 & 21MAY91 & 17JUN91 titer was neg;
Patient is having left arm pain, body aches, joint and muscle pain, lump and tenderness at injection site, red spots on upper arm.
Information has been received from a physician concerning an approximately 55 year old male with a history of shingles thirty years ago who on 19-NOV-2007 was vaccinated with Zostavax (Oka/Merck) (Lot # 658361/1090U). The physician stated that "the patient's post herpetic neuralgia has gotten 50% better since the vaccine was administered". Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
The patient is experiencing extreme muscle pain. As of 10/29/10 she was still complaining of muscle pain and visited her primary care physician, because it was difficult to lift her arm. The patient informed us that Dr. explained her muscles had not healed properly and that he would prescribe physical therapy to help the healing process.
Patient had sore arm, bursitis of shoulder, 2 weeks continuously since flu shot administered.
My son experienced muscle weakness, rapid heartbeat, palpatations of the heart, and tiredness. My son was bedridden for one week, and resulted in being more prone to physical exhaustion.
ABDOMINAL PAIN; JAW PAIN; FACIAL PAIN; PRESSURE IN LEG; LEG PAIN; BURNING FROM BRA STRAP TO BRAIN; CHEST PRESSURE AND PAIN; NAUSEA; SEVERE HEADACHE; ACHE; SHORTNESS OF BREATH; FATIGUE; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 038A21A expiry: 21-JUN-2021) dose was not reported, administered on 31-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced ache. On 31-MAR-2021, the subject experienced shortness of breath. On 31-MAR-2021, the subject experienced fatigue. Treatment medications included: paracetamol. On 31-MAR-2021 21:00, the subject experienced severe headache. On 04-APR-2021, the subject experienced burning from bra strap to brain. On 04-APR-2021, the subject experienced chest pressure and pain. On 04-APR-2021, the subject experienced pressure in leg. On 04-APR-2021, the subject experienced leg pain. On 04-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced abdominal pain. On 13-APR-2021, the subject experienced jaw pain. On 13-APR-2021, the subject experienced facial pain. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and the outcome of severe headache, fatigue, ache, shortness of breath, burning from bra strap to brain, chest pressure and pain, pressure in leg, nausea, abdominal pain, jaw pain and facial pain was not reported. This report was non-serious.
Patient received 2nd dose of vaccine on the same day. Patient did not have good memory of which vaccines were received in her previous appointment.  Monitored patient for 15 minutes after injection, no symptoms shown of any kind.
This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown dates, the patients were vaccinated three doses of hepatitis b vaccine (manufacturer unknown) (dose, frequency, route of administration and indication were not provided). The patients had titers drawn on an unspecified date, which had shown that the patients did not have immunity to hepatitis B. The outcome of event was unknown. No product quality complaint (PQC) was involved. Additional information is not expected as reporter was not willing to participate in the adverse event report.