chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Covid 19 in between doses; Diagnosed with Covid 19 in between doses/he is asymptomatic; This is a spontaneous report from a contactable other HCP. A 17-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: ER8736) via intramuscular on 26Apr2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had no prior vaccinations (within 4 weeks). The patient had Covid-19 PCR test with negative result on 19Feb2021. The patient received the Pfizer Covid 19 vaccine on 26Apr2021, and then was diagnosed with Covid 19 in between doses on May2021. The patient was scheduled for his second dose, the reporter asked if it should be delayed or if he could get it now. The patient was asymptomatic. Responded as attached below: Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. This recommendation applies to people who experience SARS-CoV-2 infection before receiving any vaccine dose and those who experience SARS-CoV-2 infection after the first dose of an mRNA vaccine but before receipt of the second dose. It was unknown when patient tested positive other than it was after 26Apr2021. There were no predisposing factors. The patient was due for the second dose yesterday (17May2021) and was asking if they need to wait for the second dose. The patient stated this appeared to be a not serious event; patient was not hospitalized and symptoms were mild and he was asymptomatic and had isolated for the 10 days. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, inefficacy of vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity between the first vaccine dose and the event onset. The case will be reevaluated should additional information become available.
pt wife called head of nursing stated husband devel a staph infect @ site of TD inj;Is being treated by FMD;stated pt arm is red,swollen @ inj site;pt not sure when onset of sx occurred or course of tx;
(Nurse Practitioner)  Family Medicine at 3/1/2021 10:50 AM    Pt called to follow up on covid-19 vaccine done on 02/24/21.  She reports that she got home that day and slept until the next day.  Fatigue resolved.  No other issues noted with vaccine otherwise.  Denies any further questions or concerns.   Pt is appreciative of phone call.      Progress Notes     2nd Attempt to call patient for follow up via phone. No answer.    Progress Notes ? Family Medicine at 2/28/2021  7:28 AM    Attempt to call patient for follow up via phone. No answer.    Progress Notes (Physician Assistant) ? ? Family Medicine Cosigned by: MD at 2/28/2021  7:29 AM   STORMONT VAIL COVID VACCINE CLINIC   Patient:                                                                 Date:  2/24/2021                                                                                              Patient is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, vision changes and increased respirations.  She denied rash, hives, difficulty swallowing, wheezing, throat tightness and hoarseness. She has a history of asthma often triggered by stress. She does have albuterol inhaler on hand, but has not used today. Denies frequent use of albuterol inhaler.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of shortness of breath, dizziness and headaches   Patient denies chills, fever, facial swelling, cough, chest tightness and wheezing       Previous Reactions: Denies    Objective    Vitals Vitals:   02/24/21 1155 BP: (!) 126/92 Pulse: 64 SpO2: 100%      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water and Tylenol 1000mg Follow up response to treatment: good. Patients symptoms all resolved prior to discharge. Her O2 remained 99-100% and she denied difficulties breathing. Her respirations decreased while she was in the bay.  Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)      Electronically Signed 2/24/2021 12:31 PM
pt recvd vax & was found to have a large ulceration of mucous membrane mouth & areas of inflammation of tongue; platelets found to be 6,000; prev blood work done 1OCT94 platelets of 242,000; adm dx idiopathic thrombocytopenia;
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 02-SEP-2015 the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (dosage, strength, route and lot # were not reported) instead of ZOSTAVAX. There was no concomitant medication reported. At the time of the report, no adverse event was reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PNEUMOVAX23, (route, dosage schedule, lot # and expiration date were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 25 minutes: more than 46 grades Fahrenheit but less than 77 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000487: US-009507513-1703USA000488: US-009507513-1702USA008062:
SOB, wheezing, throat closing after receiving Tdap / MMR. Note: pt had sx's at home not at clinic.
hurt/ sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine and it hurt 4 days and was still sore.
Sore arm & redness, fever, 1/7/17 redness spreading, swelling.
Patient developed lightheadedness, weakness, dilated pupils and bucking of legs approx 30 minutes post vaccine, recovered after 15 minutes, then developed another episode with syncope this time for a few seconds and then confusion for a few seconds.  Sent to ER for evaluation -- EKG was normal, Compr met panel was normal, urinalysis was normal, patient no orthostatic, vital signs were stable,
pt recvd vax  4JUN93 & 5hrs following vax pt exp itchy, scratchy throat; condition was felt to be a recurrence of bronchitis; following morning awoke w/congestion & a cough;
pt recvd vax; pain in lt arm; appt w/ MD 13han95;
Saturday, April 10th-  ? Received Johnson & Johnson / Janssen Covid 19 Vaccine at pharmacy at 10:00 AM o Vial 205A21A ? Had chills and overall yucky/flu like symptoms for that night, Sunday was pretty much back to normal Friday (April 16th) evening- ? Started feeling weird ? headache ? facial area tight/flushed/tick ? Worsened/blurry vision especially in right eye ? Noticed leg bruising, not sure when it?s from ? No appetite Overnight Friday into Saturday, woke up several times covered in sweat Saturday (April 17th) - ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Rested most of the day, went for small walks ? Off / on low grade fever seemingly worse at night and getting out of shower Sunday (April 19th) - ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Rested most of the day, went for small walks ? Bloodshot, tired, red eyes that don?t go away with drops Monday (April 20th)- ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Went on normal 3 mile walk and did fine ? Bloodshot, tired, red eyes that don?t go away with drops Tuesday (April 21st)- ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Went on normal 3 mile walk and did fine ? Bloodshot, tired, red eyes that don?t go away with drops
Resident noted the injection site to be red, tender and warm to the touch. PCP notified and prescribed Keflex 500 mg BID for 7 days
some arm irritation/ pain; some arm irritation/ pain; felt dazed; This is a spontaneous report from a non-contactable consumer (patient) . A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the vaccine yesterday (06Feb2021) and that it went well - only had some arm irritation/ pain and felt dazed on an unspecified date in Feb2021. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a physician via call center representative and described the occurrence of swelling in a 74-year-old female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown. It was unknown if the reporter considered the swelling and erythema to be related to BOOSTRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received a BOOSTRIX (Tdap vaccine) and had significant swelling and redness. On call with health care professional, the patient stated that about prior reaction due to electronic medical record (EMR) warning when SHINGRIX was order (has not been administered). The brand name and batch number of the GSK Tdap were unavailable but health care professional stated it was a GSK Tdap, agent filing conservatively as BOOSTRIX.
Rash and swelling of arm and underneath arm towards the arm pit area of the left arm.   Rash was hard and skin would go white when pressure was placed on the area.  Itching at the spot began on the evening of Saturday, May 22nd and in the morning it was light pink color that gradually became a darker red with an intense itch and swelling and warm often times hot to the touch. On Monday afternoon after several doses of Benadryl and cold compresses as recommended online, I went to urgent care to have it looked at closer especially since I felt swelling under my arm.
I'm not sure of the lot number, 7741678 is the Rx Number.  My left arm is extremely sore, from the injection site down to my pinkie and ring fingers.  I do not have any swelling or redness.  The ache in my should is enough that I will favor my arm all day.  I didn't sleep well because of the pain and definitely couldn't sleep on my left side.  I usually do not have any type of reaction to immunizations/shots.  I've taken 2 ADVIL and that seems to help.
pt recv vax 17FEB97 & 20min later devel a h/a, chills & a fever;pt was treated w/2 APAP & the sx resolved;
Post vax the patient failed to seroconvert. The patient sought unspecified medical attention. Additional information has been requested.
Gross blood and mucous in stool about 2 hrs after receiving DTaP, IPV and ROTATEQ vaccines.
Fever up to 102F; Swollen lymph nodes in left armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: ff2587) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN. Vaccination history included: Bnt162b2 (Dose Number: 1, product: COVID 19, brand: Pfizer, lot number: ff2589, administration date: 25Oct2021 , vaccine location: Left arm, 1st dose- no sx), administration date: 25Oct2021, when the patient was 25 years old, for covid 19 immunization. The following information was reported: PYREXIA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Fever up to 102F"; LYMPHADENOPATHY (non-serious) with onset 17Nov2021, outcome "recovering", described as "Swollen lymph nodes in left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, lymphadenopathy. Additional information- It was reported that patient administer vaccine at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks and Other medications in two weeks was acetaminophen. Patient did not suffer from covid before vaccination and did not underwent covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Initial all over muscle aches and fever. Next morning a large painful blister in the back of my throat. Then urgent diarrhea. This progressed to wheezing and a cough and what appears to be bronchitis.
had fever of 103.8 ax; pt leg red; was using APAP q 4-6hrs; saw MD 24AUG95; felt it was vaccine realted; wrote order for no pertussis; fever persisted thru 25AUG95;pt broke out w/rash; had vomiting also
No other adverse events reported.; an expired dose of PROQUAD was administered to a patient today; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 31-MAR-2022 (reported as at reporting time), the patient was vaccinated with 1 dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Expiration Date: 07-MAR-2022, dose, strength, route, lot# were not provided) for prophylaxis (expired product administered). The reporter was unable to provide the lot number but confirmed the expiration date. The reporter also confirmed that dose was properly stored up through time of administration. No further information provided. No other adverse events reported. No product quality complaint.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L010596, expiration date 16-APR-2017). No adverse effect reported. This is one of 4 reports from the same reporter source (MARRS #s 1509USA001842, 1509USA001922 and 1509USA001923). Additional information is not expected.
Left arm involuntary tremor; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 12:00 (Batch/Lot number: unknown) at the age of 35 years as dose, 1 single for covid-19 immunisation. Relevant medical history included: "Graves Disease" (unspecified if ongoing). Concomitant medication(s) included: PROPYLTHIOURACIL. The following information was reported: TREMOR (non-serious) with onset 02Aug2021 12:00, outcome "not recovered", described as "Left arm involuntary tremor". Therapeutic measures were not taken as a result of tremor.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up (27Sep2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Janssen COVID-19 Vaccine EUA Terrible headache (teeth even hurt) 7 days and on going, elevated diastolic blood pressure 5 days and on going, irregular heart rhythm 5 days and on going, shortness of breath after simple physical movements 5 days and on going,  diarrhea for 3 days, fatigue and weakness 7 days and on going.  Tylenol extra strength- no results,  blood pressure check 3/18/2021, blood work ordered and drawn 3/19/2021.
The pt experienced "dew drops on rose petal" crusty lesions, various sizes, also vesicles on fingers, pharynx, probably varicella but may be coxsackie as well.
had pain in lower left leg on the outside when going to bed as I laid my leg on bed which was unusual, in morning area on the leg seemed hard and when touched it hurt, at this time I went to urgent care
01/28/11 - area on (L) forearm with very slight induration & erythema, no complaint of discomfort 01/31/11 - induration/erythema resolved, no residual.
EXTREME WEAKNESS (could not get out of bed in the morning even with assistance), shakiness, loss of appetite
Late second dose /second dose on 11/1/2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received 1st dose of Twinrix on 25th October 2019).   On 01-NOV-2022, the patient received the 2nd dose of Twinrix. On 01-NOV-2022, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose /second dose on 11/1/2022). The outcome of the drug dose administration interval too long was 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: 02-MAY-2023 The patient received 2nd dose of Twinrix late than recommended time frame, which led to drug dose administration interval too long. The reporter did not consent to follow up.
I have been feeling pain in my right lateral  side of the breast and in my axilla area. It feels like throbbing pain and my arm gets a little heavy. I have experienced this after my second COVID vaccine ( Pfizer )
Also had stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 88-year-old female patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, single), administration date: 20Jan2021, for covid-19 immunisation; BNT162b2 (dose 2, single), administration date: 10Feb2021, for covid-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 26Jun2022, outcome "unknown", described as "Also had stroke".  Clinical course: The patient also had stroke on 26Jun2022 after taking the same sequence of 4 shots (3 Pfizer, 1 Moderna).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 9 week old female with gastrooesophageal reflux who on 25-JAN-2008 was vaccinated PO with her first 2.0 ml dose of ROTATEQ (lot# 657673/0904U) and vomited immediately after. Medical attention was sought via physician's office. The outcome was unknown. There was no product quality complaint. Additional information has been requested. 02/11/2010 Follow-up information from the reporting physician concerning a 9 week old female who on 23-JAN-2008 was vaccinated PO with her first dose of GARDASIL (lot# 657673/0904U). There was to illness at the time vaccination. Concomitant vaccinations administered on that same day included the first IM dose of PEVENAR (lot#041339), the first IM dose of RECOMBIVAX HB and (DAPTACEL) (lot# C2933AB) and first IM dose of (IPOL) (lot# A047U). Immediately after the dose of GARDASIL (lot # 657673/0904U) the patient vomited and subsequently removed immediately after immediately after dose. Additional information has been requested.
Menorrhagia (heavy period/ menstruation)  My period usually lasts for 3-4 days and is fairly light after the first day.  However, my period after the COVID 19 vaccine lasted 5-6 days and was very heavy for the first 4 days.  This was accompanied by worse than normal menstrual cramps as well.