chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough COVID-19 case with unknown symptom onset date: altered mental status. Hospitalized 8/24/2021-8/25/2021. Death 8/25/2021. Per medical records, patient presented to ER with altered mental status. Patient was emergently intubated and was admitted to ICU. Patient's previous medical history and symptoms were unable to be obtained due to patient's clinical condition. Per patient's husband, she was recently released from hospital and had recently had COVID-19. Patient expired on 08/25/2021. Vital records data not available yet.
pt recv vax 15JUL96 & 2 days p/vax pt exp a local rxn consisting of redness, & fine bumps;the duration of the exp was 2 days then the rxn resolved;
SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned an 88 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right hip replacement, and concurrent conditions included: hypertension, osteoarthritis, calcium channel blockers allergy, cholesterol medication allergy, dust allergy, mold allergy, pacemaker, and watchman. The patient experienced drug allergy when treated with hydromorphone hydrochloride, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 15-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-NOV-2021, the patient experienced swelling at injection site. On 16-NOV-2021, the patient experienced redness at injection site. On 16-NOV-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 16-NOV-2021, and had not recovered from redness at injection site, and swelling at injection site. This report was non-serious.
She felt as if she was wild; She never slept on the same night; An hour & 1/2 later, she started feeling tired after receiving 1st dose; She woke up with chills; Fever; Terrible headache; Muscle aches in her bones at midnight; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt as if she was wild), INSOMNIA (She never slept on the same night), FATIGUE (An hour & 1/2 later, she started feeling tired after receiving 1st dose), CHILLS (She woke up with chills) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and VITAMINS NOS for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (She felt as if she was wild), INSOMNIA (She never slept on the same night), FATIGUE (An hour & 1/2 later, she started feeling tired after receiving 1st dose), CHILLS (She woke up with chills), PYREXIA (Fever), HEADACHE (Terrible headache) and MYALGIA (Muscle aches in her bones at midnight). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (She felt as if she was wild), INSOMNIA (She never slept on the same night), FATIGUE (An hour & 1/2 later, she started feeling tired after receiving 1st dose), CHILLS (She woke up with chills), PYREXIA (Fever), HEADACHE (Terrible headache) and MYALGIA (Muscle aches in her bones at midnight) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient was tested Positive with COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional information includes for concomitant product where patient reported of taking Thyroid medication.   This case was linked to MOD-2021-273988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received on 02 Aug 2021, where patient reported of taking second dose of vaccination. No significant information was provided.
feeling of nausea followed by syncope; colleagues noticed stopped breathing & administered CPR; transported to hosp admitted to ICU; discharged 3 days later; h/a persist since vaccination;
Patient had appx 3 inch of swelling and redness around site of injection as well as pain at the injection site.
Very tired; Feeling like she is fighting off a cold; Stomach upset for four days; She is normally not this lethargic; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021562659 (Pfizer).  A female patient in her 60's received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) at the age of 7 decade as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "Very tired"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Feeling like she is fighting off a cold"; ABDOMINAL DISCOMFORT (non-serious), outcome "not recovered", described as "Stomach upset for four days"; LETHARGY (non-serious), outcome "not recovered", described as "She is normally not this lethargic"; HEADACHE (non-serious), outcome "not recovered", described as "headaches".  Additional Context: Caller states she took the first dose of the Pfizer Covid vaccine on 04May2021 which was two weeks ago, concerned of any side effects that are still lingering, could this be related to the vaccine. Caller states that from the time she got the vaccine she started to feel very tired, feeling like she is fighting off a cold, states last week she had stomach upset for four days, unsure if it is associated with that. Caller states she has the second dose coming up next week and she is extremely wary. Caller declines to provide any further information for a report, does not want to give out any personal information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in to get Moderna vaccine and is under aged for this vaccine. Patient's parents have been notified.
TIRED; This spontaneous report received from a consumer concerned a male of unspecified age. 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, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Redness and swelling, pain at injection site Shivering Fever Upset stomach Tired and sore Symptoms lasted through the night, still had fever in the morning. Took a Tylenol in the morning, eventually started to feel better. Slept a lot throughout day, fever subsided during the day. Felt back to normal second day after vaccine
Patient claims having redness and a burning sensation at injection site. Patient called 9/8/16 for suggestion on management of discomfort.
Pregnant at the time the flu shot was administered (9 weeks) and baby stopped developing at 9 weeks, 1 day (showed on ultrasound at 12 week appointment). Would be due 05/31/2020.
We vaccinated 20 people with vaccine that was out of date since last Friday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We vaccinated 20 people with vaccine that was out of date since last Friday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second 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. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We vaccinated 20 people with vaccine that was out of date since last Friday). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (We vaccinated 20 people with vaccine that was out of date since last Friday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported.  The 20 patients were vaccinated with the Moderna COVID-19 vaccine that expired on 24-Sep-2021. The vaccinations were administered over 3 days, starting on 27-Sep-2021 and ending on 29-Sep-2021 to all the patients.  No treatment medications were not provided.
That evening my arm was sore, I had a headache the next day, and it never went away. It was mild.  I did not miss work, I thought that it was a simple headache, I had it every day. I took Tylenol and ibuprofen.
On 7/16/12, patient received GARDASIL #1. Patient c/o pain & swelling in pelvis. Patient was on her period for HPV #1 so mom attributed sxs to menses. With GARDASIL #2 on 9/17/12, patient again experienced the same sxs, and she was not having her period. Patient was seen in an urgent care center. She has improved.
She got her vaccine on  Saturday, had no problem at the time of the vaccine.  About 48 hours later on Monday 9/19/22 she started to develop a rash on her head at the scalp,  and it started very very itchy, and very uncomfortable.  It started on her face, down her nose, neck, down to the torso, behind the ears.  At this point it is uncomfortable and oozing.  She had no idea it was from the vaccine.  She had no problems with the first four, no problems until Monday.  She went to the Medical Center to have them look at the strange rash, 3 different doctors came and saw her and they decided that it was from her vaccine on Saturday.  She was treatment with Triamcinolone ointment and then they gave her two different strengths of that, stronger for the body and milder for the face.  Then gave her Centirazine hydrochloride which has not helped much.  She only takes one a day and so far not working, and still pretty uncomfortable.
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Patient request a first dose Janssen vaccine on 6/29/21.  After giving the vaccine, pharmacy was later made aware that she had received the same vaccine from a different store on 6/26/21.
day or so after vaccination developed dizziness and vertigo.  Now 6 days later better but not gone.
fist size red area with some burning and itching. On day 6, red area began increasing in size and burning and itching increased significantly
Case PHEH2016US028840 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to adult male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscular in right deltoid on 12 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been revaccinated. No adverse event was reported following this medication error. The case as assessed as non serious by the nurse.
sz activity @ home 13JUL94 transported to hosp; 1 sz witnessed by hosp staff;
This spontaneous report was received from a physician via company representative, referring to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. In May 2014 (reported as 4 years ago), the patient was vaccinated with M-M-R II, subcutaneously (SC) for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (manufacturer unknown), (SC) for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). On an unknown date in May 2014 (reported as one week after administration of M-M-R II, the patient experienced type 1 diabetes mellitus. The patient sought medical attention (unknown type). No further information was provided. At the time of the report, the outcome and the causality assessment between type 1 diabetes mellitus and the suspect therapies was unknown. Upon internal review the event type 1 diabetes mellitus was considered to be medically significant.
iron overload; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IRON OVERLOAD (non-serious), outcome "unknown", described as "iron overload". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. received HPV on 11-6-07 along with Tdap, MCV4.  Mom states that since that date pt. had experienced abnormal menstrual periods (ex for 1 mo).  Mom suspects HPV caused it.
patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine; patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) at the age of 77-year-old as single dose; dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) in 2021 at the age of 77-year-old, as single dose for covid-19 immunisation. Patient history reported as no. There were no concomitant medications. The patient got COVID two to three months after receiving his first and second dose of the Pfizer Covid 19 Vaccine and was currently hospitalized. He's in the hospital and he's been sick for 26 days and it's real bad. He got diagnosed 28 days before, so sometime in Aug2021, he had worsened since being in the hospital. The patient got the vaccine 3 months before he got COVID. Event reported as serious as hospitalization from 01Sep2021. The outcome of the event was not recovered (reported as worsened). The reporter's concern was why did the patient get Covid, why did it hit him so strong after having the vaccine, the vaccine was to prevent, so why did it hit him so hard.  Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Tdap vaccination on 3-5-16 and on 3-10-16 he began to develop the following symptoms in L arm: joint pain, arm spasm states for 48 hours straight and now just off and on, tenderness, fever, warmth at site. Symptoms had been improving as of 3/15/16.
Patient came in for her 2nd SHINGRIX, but complaining that she is still in pain from the last shot. Per patient, she has been feeling pain at the injection site, and restricted movement of her arm since her shots. Every time she moves her arm she feels the pain. She has been taking ADVIL and is feeling better. However, she is not completely pain-free.
Pt developed abd pain and diarrhea about 5:30am and then diffuse erythema, hives, dyspnea, tongue lip and throat swelling around 6:30 for which he was administered epinephrine and admitted to the hospital
Wife reports that he has felt ill since receiving vax - headache, fevers - yesterday 100.8, diarrhea.  Dr. visit scheduled 6/20/06 - blood work 6/19/06.  Returned from 8 day overseas trip on June 3rd, 2006.
48-year-old female past medical history recurrent neurocardiogenic syncope, Mobitz 1 AV block, hypertension, hypothyroidism, history of gastric bypass (2018), and anxiety presents from vaccine clinic with an episode of presyncope   Patient was at the vaccine clinic this morning to get the second dose of her COVID vaccine.  Approximately 5 minutes after receiving the second dose, she noted gradually worsening palpitations, mild nausea, shortness of breath, and a sensation that she has been to pass out.  Staff in the vaccine clinic were concerned the patient was having allergic reaction, so they gave her an EpiPen.  Of note, however, patient denied any cough, chest tightness, sensation of throat closing, wheezing, abdominal pain, diarrhea.  She reports that today's episode is nearly identical to multiple prior episodes of syncope/presyncope.  She has been worked up extensively for these episodes, including echo, stress test, and Holter monitor.  In the ED, she reports feeling back to her baseline.  She denies any ongoing symptoms, including presyncope, chest pain, shortness of breath, palpitations, diaphoresis, nausea/vomiting.
since she took the COVID-19 Pfizer vaccine two-three months ago she has noticed " increase achiness and stiffness".; since she took the COVID-19 Pfizer vaccine two-three months ago she has noticed " increase achiness and stiffness".; since she took the COVID-19 Pfizer vaccine two-three months ago she has noticed " increase achiness and stiffness".; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (51-years-old at the time of vaccination),  (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; received tofacitinib citrate (XELJANZ XR), oral from an unspecified date (Batch/Lot Number: ED3279) to an unspecified date, at 11 mg, 1x/day (11MG/TAKE 1 TABLET BY MOUTH ONCE DAILY), via an unspecified route of administration from 2019 (Batch/Lot number was not reported) to an unspecified date, at 5 mg for an unspecified indication. Medical history included Psoriatic arthritis mutilans from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) and meloxicam (MOBIC) taken for an unspecified indication, start and stop date were not reported. Patient confirmed she began Xeljanz "several years, around 2019". She was previously on Otezla, Stelara, Humira, Enbrel and Xeljanz 5 mg dose but they were discontinued due to lack of efficacy. Provided review of prescribed regime, reviewed educational topics, and completed the adherence medications scale (withheld). Educated that Xeljanz may cause changes in WBC and red blood cell count; reviewed importance of doing blood work while taking Xeljanz. She indicated she follows up with her physician quarterly. She indicated that since she took the COVID-19 Pfizer vaccine two-three months ago she has noticed " increase achiness and stiffness". She stopped medication temporarily due to COVID-19 pandemic and when she received COVID-19 vaccine was instructed to stop medication temporarily. Updated medication list and reviewed allergy list. AE survey completed. The clinical outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature involved were from 6° F to 14° F for 72 hours. It was not previous temperature excursion, and a data logger was not involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001049: Original Case : 1704USA001049 US-009507513-1704USA002217: Original Case : 1704USA001049.
Symptoms of UTI came on suddenly during the evening hours of 12/25/09. Pain was so severe that I was taken to the emergency department.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 05Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Neutropenia" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; SANDOZ ADAPALENE/BENZOYL PEROXIDE, start date: 27Dec2021. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 24Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Negative; (24Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Reportedly, the patient received a COVID 19 treatment with anti viral Paxlovid form 14Jul2022 to 19Jul2022. It was reported that, the symptoms returned and patient tested positive 24Jul2022 after testing negative/ symptom free on 20Jul2022. Have fever, congestion, runny nose, sneezing and cough. Feel worse than original infection. AE treatment was reported with antibiotics Doxycline.