chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has lupus and a couple days ago, she started having inflammation pain; has lupus and a couple days ago, she started having inflammation pain; Fever; Achy; Pleuritic pain; Shortness of breath; O2 level was a little lower it was in the low 90's and she usually runs 96 to 97; This is a spontaneous report from a contactable consumer reporting for herself.     A 75-years-old female patient received the second dose of bnt162b2 (BNT162B2)vaccine  , intramuscular in the right arm  on  08Feb2021 15:30 at single dose  for covid-19 immunisation .  Medical history included systemic lupus erythematosus , asthma, thyroidectomy .  The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 18Jan2021.  The patient  has lupus and a couple days ago, she started having inflammation pain  on 14Feb2021 with outcome of unknown, O2 level was a little lower it was in the low 90's and she usually runs 96 to 97  on Feb2021 with outcome of unknown , fever  on 09Feb2021 with outcome of unknown , achy on 09Feb2021 with outcome of unknown , pleuritic pain on Feb2021 with outcome of recovering , shortness of breath  on Feb2021 with outcome of unknown.  The patient underwent lab tests and procedures which included oxygen saturation: low 90's.  The second day, she had a little bit of a fever and was achy. She has lupus and a couple days ago, she started having inflammation pain. It has progressed and went to pleurisy pain. She has really been down for the count. She has had problems breathing with the pleurisy pain, but she has had no fever. She has had a little shortness of breath. She has a pusle oximetry and her O2 level was a little lower, it was in the low 90's and she usually runs 96 to 97.The patient  has taken Tylenol and the pleurisy pain is better. She can breathe without pain.  The patient is  wondering if the vaccine causes problems or after affects for more than a week sometimes or if  this is just plain lupus causing issues.  Information on the lot/batch number has been requested.
Day 1: Fever, chills  Day 2: swollen lymph nodes under armpit; dizziness
Spike a 103 fever 24 hours later, kidney pain, and 4 days later my lymph nodes under my arm on the same side swelled up a painful amount, and a few really bad migraines, reaction from the sun with rash all over my body, dizziness, BP of 150's/110's and meds barley being it back into range. Bells Palsy and regurgitating valves in my heart
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-1 test: (Positive) Tested positive. In 2021, Blood test: unknown.         No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had rheumatoid arthritis flares and was put on Prednisone for 25 days and had been able to taper off to five days in the last five months. She just done blood work to see if she get tapered down none at all. She had Covid 19 vaccine symptoms of body aches, nausea and fatigued on the second shot. The reporter's causality for the event of BODY ACHES and NAUSEA with RINVOQ was no reasonable possibility. The reporter's causality for the event of TESTED POSITIVE FOR COVID and RHEUMATOID ARTHRITIS FLARES was not provided. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-620779 (Patient Link).
Significant swelling, warmth, tenderness & erythema the day after receiving vaccine, improved within a few days. No specific treatment required. No fever.
Mother brought child into clinic to receive vaccinations. I explained to mother that child would be receiving the 1st dose of the the seasonal flu. Mother verbalized understanding and gave consent to get vaccination. My provided vaccination card that did not have any documentation of a previous shot. Child record was also viewed and showed not history of previous vaccination. Mother returned to clinic several hours later stating that child had received a flu vaccine on 10/16/2009. Upon further investigation it was found that child had two medical record numbers. On listed the child as a 01 and the other listed the child as a 02. The documentation was found under the 02 prefix. The nurse manager and provider both spoke with the mother and informed her that the child still needed to come back in 4 weeks to have the 2nd dosage of seasonal flu.
Allergic reaction to site. Red / Bruised and 3 side to side dots.
Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) outcome was unknown. Not Provided          No concomitant medications were provided. No treatment details were provided.
PRIVACY PHARMACY INADVERTENTLY DISPENSED EXPIRED COVID VACCINE TO PRIVACY HEALTHCARE @ PRIVACY. WHICH WAS ADMINISTERED.
No adverse event; temp excursion of 47.9 F for 47min; This spontaneous report was received from a healthcare professional and refers to a 7-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) first dose administered orally (strength, dose, lot #, and expiration date were not provided) for prophylaxis. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) second dose administered orally (strength, dose, lot #, and expiration date were not provided) for prophylaxis. On 21-DEC-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1892784, expiration date: 03-DEC-2023, administered orally (strength was not provided) for prophylaxis (Product storage error).  On 01-DEC-2022, the vaccine underwent a temperature excursion at 47.9 Fahrenheit degrees (F) for 47 minutes. The temperature excursion occurred as a result of reading from a Digital Data Logger. No previous temperature excursions were reported. No adverse events (No adverse event).
about 6:45 pt began vomiting, became lethargic & cyanotic around mouth;pt was taken to MD dx hypotonia, hyporesponsive state & ordered no more pertussis;
Intermittent radicular leg pain; This spontaneous case was reported by a patient and describes the occurrence of RADICULAR PAIN (Intermittent radicular leg pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RADICULAR PAIN (Intermittent radicular leg pain). At the time of the report, RADICULAR PAIN (Intermittent radicular leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Family was eating dinner and he got very quiet then started jerking around.  Reports seizure lasted only 30 seconds at the most.  To ER via ambulance where temperature was 104 "something".  ER diagnosed it as febrile seizure and said both ear drums red and gave amoxicillin and urged Tylenol and Motrin to keep temperature down.  No rash visible.
Breakthrough case admission after 3 vaccines Pfizer 3/5/21 Lot# EN6206;  Pfizer 3/26/21 Lot# ER8732;  Pfizer 11/14/21 Lot# FE3590
On 8/23/00, vomiting at school, fever (low-grade 99.6), crying, whining, colicky cough, dull eyes, lethargic with severe headache. On 8/24/00, tonsils enlarged, labored breathing, bowel movements (putrid) and no appetite. On 8/26/00, rash on stomach and back and joints aching. On 8/28/00, said her "heart hurt". Given Motrin and Reglan but declined Reglan. Dx'd febrile illness (suspect viral)
Friday afternoon: left arm started getting sore. by Friday evening developed pounding headache, complete body aches, fever through out the night. took Tylenol around 3 am Saturday morning. Saturday: chills, headache, feverish, and weakness. By Midnight was feeling better. Sunday 3/21/2021 back to normal self
From initial information received on 09/30/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 49 year old female patient received a TD ADS adult vaccination, lot number U1347AA, administered in the left deltoid on 09/24/2004.  The route of administration was not reported.  The following day, on 09/25/2004, the patient developed a local reaction of redness and swelling measuring 3 x 3.5cm at the injection site.  The area was also warm and tender.  The patient was seen by a physician on 09/28/2004.  At the time of this report the patient had not recovered from these events.
Patient given a Menquadfi when he was due for a MenB vaccine. He had a Menquadfi on 06/14/2023, when a booster if needed is not recommended for 3 years. Extra dose given, we have been unable to reach patient to confirm if he had any complications from this extra dose and to notify him of this error.
Severe pain at injection site, nausea, chills,  fever 100 degrees, body aches,severe headache, feeling unwell, weakness.none
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is fifth of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient.
Member started feeling sick and running a fever as high as 102 for about 4 days.
From telephone contact received on 06/25/2002, it was reported that a 7 week old infant received ACTHIB in the right thigh and IPOL in the left thigh on 06/21/2002.  Patient developed a local reaction of redness and swelling in the right thigh.  Physician prescribed cool packs to be applied to right thigh and infant Tylenol.  Reactions resolved as of 06/22/2002.  Patient also received Recombivax in the left thigh on 05/16/2002.  Linked with case U2002-00472.
Patient received vaccine in office between 3:30 PM- 4 PM.  About 3.5 hours later developed fever, chills with complaints of left arm pain.
Tender red warm area approximately 4 x 5 cm (L) deltoid - no systemic symptoms.
I was very tired and had lots of congestion. My numbers were very high for my diabetes and my doctor has since changed medication to fix the numbers. I ended up having a bad cough and I was given Paxlovid to treat the symptoms. I don't know if it helped because I didn't feel that sick.
Patient stated they felt "lightheaded, clammy and sweaty". BP was 72/48, HR was 44, and  O2 sat was 99%. Started about 10 minutes after receiving vaccination. No interventions needed and no transport. Recovered on own and was able to walk out of clinic.
Patient received these vaccines listed below on 3/16/2012 and developed a fever immediately after receiving them. He then developed a prolonged illness of fatigue, poor appetite, poor sleep and a high pitched cry. By 5/13/2012 he was unable to say "MaMa" like he had said previously. By 6/2012 he developed bowel problems such as frequent vomiting, poor appetite, food intolerances to dairy/gluten, weight loss, chronic loose stool often with blood and sometimes constipation. By 18 months (8/2012) he had regressed into autism: lost functional play, lost social skills, lost language, stopped responding to his name, and engaged in spinning/flapping of his hands.
EMPLOYEE came in d/t allergic reaction after yesterday's MMR and Hep B vaccination; assessment: Red itchy bumps (hives) on neck; onset this AM. No other complaints. EMPLOYEE  provided with 1 capsule Benadryl; informed about possible side effect of drowsiness when operating heavy machinery/driving. EMPLOYEE  advised to seek further medical assistance if developing SOB, swollen airways/face and/or other S/Sx of anaphylaxis.
pt recv vax 1985 & in 1987 pt began exp sx of multiple sclerosis which was dx in 1990;
Developed tachycardia 03/27/03.  Wore halter monitor. No heart abnormalities.  Thyroid elevated.
FELT TERRIBLE; HEADACHE; REALLY TIRED; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced felt terrible. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced really tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt terrible, headache, and really tired on MAR-2021. This report was non-serious.
I developed a swelling on the arm where I was pricked after a day. It got swollen and could not pick a cup for some days and I thought it was going to get better, after a month that is when I realized that it was not going away. I started taking over the counter pain medications when sleeping was now difficult. It got even worse that taking a bath was now difficult that is when I decided to visit my primary doctor after waiting for the appointment I was given, She sent me for an exray because the whole elbow is now hurting and nothing was diagnosed. But I am still suffering  with pain, sometimes I feel like there is fire on the muscle going to the shoulder. I have difficulties with sleeping, there is no position that is comfortable. I am suffering I do not know what to do. Please Please help me!!!!!
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jun2023, outcome "recovered" and all described as "Tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2023) Positive, notes: Covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271876 same patient, different vaccine dose number, different event;
Kinrix was expired on May 7th 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 22-MAY-2023, the patient received Kinrix. On 22-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix was expired on May 7th 2023). The outcome of the expired vaccine used 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: 22-May-2023  Medical assistant reported that 2 twin patents received an expired dose of Kinrix on 22nd May 2023.  Kinrix was expired on 7th May 2023. The reporter consented to follow up. Follow up preferred via email.; Sender's Comments:  US-GSK-US2023072485:Linked case for twin's patient
Pt stated that he got the vaccine and then hours later pt had issues breathing and had to call EMS and be rushed to the hospital. Pt has history of COPD. Pt was unsure if this is vaccine related or if this occurred from another underlying issue.
rheumatoid arthritis symptoms returned/flares; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4319170-00.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Dec2021, outcome "unknown", described as "rheumatoid arthritis symptoms returned/flares". The action taken for adalimumab was temporarily withdrawn.  The reporter's assessment of the causal relationship of the [rheumatoid arthritis symptoms returned/flares] with the suspect product was not provided at the time of this report. Since passible determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
nausea; weakness; fever; photophobia; body aches; night sweats; chills; headache; arm pain; This is a spontaneous report from a contactable Pharmacist (Patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3246) via intramuscular in the left arm on 13Jan2021, at 12:30 (at the age of 35-year-old) as a single dose for COVID-19 immunization. The patient medical history included ulcerative colitis, adhd (Attention deficit hyperactivity disorder), prediabetes, high cholesterol. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included mesalazine (LIALDA), methylphenidate hydrochloride (CONCERTA), cetirizine hydrochloride (ZYRTEC), vitamin d, citalopram and atorvastatin. The patient previously took historical vaccine first dose of bnt162b2 (Lot number: EK5730), via intramuscular, on left arm on 22Dec2020, at 16:30 (at the age of 35-year-old) for COVID-19 immunization and experienced arm pain. On 13Jan2021, the patient experienced arm pain at 13:30 and, headache at 14:30. On 14Jan2021, at 00:30 body aches, night sweats, chills and at 12:30 patient had fever and photophobia. On 15Jan2021, at 12:30 the patient had weakness. On 16Jan2021 at 12:30 the patient had nausea. The patient did not receive any treatment for the events. The outcome of the events was reported as non-serious. The outcome for all the events was recovered on an unknown date in 2021.
hardly stay awake; exhausted; body tired/bodyaches; feels freezing; no energy; cold to touch; entire body sore; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (hardly stay awake), FATIGUE (exhausted), MYALGIA (body tired/bodyaches), CHILLS (feels freezing) and ASTHENIA (no energy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced SOMNOLENCE (hardly stay awake), FATIGUE (exhausted), MYALGIA (body tired/bodyaches), CHILLS (feels freezing), ASTHENIA (no energy), FEELING COLD (cold to touch) and PAIN (entire body sore). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (hardly stay awake), FATIGUE (exhausted), MYALGIA (body tired/bodyaches), CHILLS (feels freezing), ASTHENIA (no energy), FEELING COLD (cold to touch) and PAIN (entire body sore) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given. Action taken with mRNA-1273 in response to the events was  not applicable