chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 80 y.o. female presents with 3 to 4 days of malaise.  She just feels terrible.  Can barely walk.  Increasing cough and dyspnea.  She was seen on the day prior to admission at which time it COVID-19 screen came back positive.  Her O2 sats were 95% at home and we were trying to set her up for an antibody infusion however due to progressive symptoms of malaise and weakness she was sent to the emergency room instead for further evaluation.  She has a history of bilateral adrenal metastases felt to be related to neuroendocrine tumor or small cell cancer of unknown primary.  Most likely a cold pulmonary primary.  She has a distant history of squamous cell cancer of the left upper lobe dating back to 1999.  She has some underlying COPD with chronic tobacco use.  No tobacco use in several years.  She has had recent lower extremity weakness and headaches and backache concerning for recurrent cancer since she has been off of her Keytruda for few months due to side effects.  CT of chest abdomen and pelvis failed to reveal any new or progressive disease.  An MRI of the brain had been planned followed by MRI of the spine to rule out progressive spinal stenosis prior to the current illness.  She has a history of atrial fibrillation treated with ablation and a permanent cardiac pacemaker.  On chronic Eliquis for this.  Also history of hypertension, hyperlipidemia, diabetes mellitus, gastric ulcer, and adrenal insufficiency.  Chronic peripheral neuropathy felt to be related to alcohol use.  Was started her on Remdesivir and Decadron.
PT WEEPING 10 MINUTES AFTER SHOT. CALLED 911 AT HER REQUEST. NO SYMPTOMS OF ANAPHYLAXIS. PT STATES SHE FELT COLD AND HANDS FELT STRANGE AS WELL AS MIDSECTION
Pt lost consciousness for ~ 45 seconds after HPV vaccine was administered Associated symptoms: Urinary incontinence, limb jerking, eye rolling, muscle stiffness, and head turning to the left.  Symptoms lasted approximately 45 seconds. No prior hx seizures Pt given ibuprofen for HA post episode and parent encouraged to take patient to ER for evaluation.
no adverse effects; vaccine was administered following multiple temperature excursions; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and previous drug allergies or reactions were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 10-MAY-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (ml), once, lot number W006583, expiration date: 23-AUG-2023 (route of administration was not provided) as prophylaxis (product storage error).  The suspect vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 degrees Fahrenheit (F) for 7 minutes, 27-MAY-2022 5.7 F for 5 minutes, 06-JUN-2022 5.9 F for 6 minutes, 09-JUN-2022 5.4 F for 4 minutes, 14-JUN-2022 5.7 F for 7 minutes, 17-JUN-2022 29.1 F for 39 minutes, 20-JUN-2022 7.2 F for 10 minutes, 22-JUN-2022 8.4 F for 15 minutes, and 28-JUN-2022 5.2 F for 3 minutes.   Total excursion time was 96 minutes. No temperature excursion occurred prior to 11-MAY-2022.  No additional adverse events were reported  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007847: US-009507513-2207USA007928:
Itchy painful rash that began on left wrist and hand. Within 12 hours, it spread across my torso, up my chest and on to my other wrist/hand; Small bumps similar in appearance to heat rash, they itch terribly and sometimes felt bruised; Itchy painful rash that began on left wrist and hand. Within 12 hours, it spread across my torso, up my chest and on to my other wrist/hand; Small bumps similar in appearance to heat rash, they itch terribly and sometimes felt bruised; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in left arm, on 08Mar2021 at 15:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Past medical history included allergies to penicillin, cephalosporins and nickel. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Medications were used within 2 weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), fludrocortisone (MANUFACTURER UNKNOWN), effexor (MANUFACTURER UNKNOWN) and loestrin (MANUFACTURER UNKNOWN), for an unknown indication. The facility where the most recent COVID-19 vaccine was administered was at a hospital. On 17Mar2021 at 05:45, the patient experienced an itchy painful rash that began on her left wrist and hand. Within 12 hours, it spread across torso, up chest and on to other wrist/hand. Small bumps similar in appearance to heat rash. They itch terribly, and sometimes it feels bruised. Therapeutic measures had taken as resulted to events and included the treatment with steroids and benedryl orally. It was reported that, the patient had slept for a few days because of that and had the rash for 5 days and didn't feel it getting better. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for events itchy rash, painful rash, itchy and bruised was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
That night, "I" went to bed and woke up to attend to "my" dog and when "I" opened my eyes "I" was dizzy and fell over when "I" stood up; That night, "I" went to bed and woke up to attend to "my" dog and when "I" opened my eyes "I" was dizzy and fell over when "I" stood up; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 03Mar2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medicines within two weeks prior to the COVID-19 vaccine. On 04Mar2021 at 02:30, the patient went to bed and woke up to attend to dog and when the patient opened her eyes, the patient was dizzy and fell over when she stood up. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy and fall were recovered with sequelae at the time of this report.   No follow-up attempts are needed. No further information is expected.
take his second vaccine of moderna on may 3rd but he couldnt take it; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (take his second vaccine of moderna on may 3rd but he couldnt take it) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (take his second vaccine of moderna on may 3rd but he couldnt take it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (take his second vaccine of moderna on may 3rd but he couldnt take it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
PLEASE NOTE: JANSSEN COVID-19 VACCINE NOT ADMINISTERED  BY REPORTING PROVIDER. PT RECEIVED VACCINE ELSEWHERE. ADVERSE EVENT: Here for 4 days of swollen painful lower lip with one upper lip papule. These got better with aloe vera but are now back. Lower lip swollen with blotchy hyperpigmentation, some soreness and burning feeling No fever or other symptoms.  Had Janssen vaccine on April 2.
Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurts; I throw up twice yesterday; I got a little sick; I just got a little chill; I got chills on the lower part of my back; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration at the age of 50 years, on 25Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated, "Yesterday I took my second vaccine shot and my side effects this morning was a little back problems, lower back, my arm is hurting, and I throw up twice yesterday, I got a little sick. So, I just wanted to call and let somebody know." It was also stated, "Yesterday when I got home after the shot, I just got a little chill and then I laid down, I throw up twice and I just laid down and laid down. And when I woke up I was calling you all since 1 in the morning because my arm was killing me." It was stated, "Yes, my arm hurts and my back, I am in my house and I got the back thing on for, the heating pad (treatment), just for my back." The consumer stated, "I took aspirin because I throw up twice yesterday so I just took aspirin. And then I was laid down and I woke up this morning and I took one in the morning. I have been trying to call you all morning, all morning I just got, just to let you know that my arm is hurting and I got a chills on the lower part of my back." Therapeutic measures were taken as a result of little back problems, lower back; hurts(back) (back pain), i throw up twice yesterday (vomiting). The outcome of the events was not recovered.
Patient lost consiousness at completion of injection, then there was body movement and he because concious.  He then became nauseous and began dry heaving then vomiting clear mucous.  He then motioned that he was choking and his throat was tight but refused an offer for epineprine administration.  He sat until his symptoms subsided.  EMS was called and arrived to evaluate the patient.  He refused transport to the hospital and they did not have to provide any additional medical care at the scene.  Patient went home under supervision of his wife.
Severe pain upon insertion of the needle, worsening with injection of the quadrivalent flu vaccine. Immediate pain in shoulder afterwards, severe, lasting for several days with loss of range of motion. Persistent pain with some limitation in range of motion and paresthesias along inner aspect of arm, hand and medial three fingers.
Bone pain in both legs; Was "debilitating" and she could barely walk for a couple of days afterwards; Was "debilitating" and she could barely walk for a couple of days afterwards; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Bone pain in both legs"; GAIT DISTURBANCE (non-serious), ASTHENIA (non-serious) all with onset Mar2021, outcome "recovered" and all described as "Was "debilitating" and she could barely walk for a couple of days afterwards". It was unknown if therapeutic measures were taken as a result of bone pain, gait disturbance, asthenia.  Additional information: The patient also received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. It was unknown, whether the patient received any other vaccine in four weeks. It was unknown, whether the patient was diagnosed with COVID prior vaccination. It was unknown, whether the patient tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse effects reported; a 46 year old female patient, received one dose of PROQUAD; This spontaneous report was received from a registered nurse, concerning a 46 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT)  On 22-MAY-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), subcutaneously in the left arm, lot # S000623 and expiration date on 06-JUL-2020, for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
SARS-CoV-2 test positive; SARS-CoV-2 test positive; This is a spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is 3rd of 3 reports. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3302, expiry date: unknown), via an unspecified route of administration, in arm on 20Jan2021 (at the age of 84-years-old) at single dose for covid-19 immunisation. The patient medical history was none. Concomitant medications were not reported. The patient was positive for covid on 03Feb2021. The contactable nurse calling about COVID vaccine. She was director at an Assisted Living, and pharmacy administered vaccines to residents on 20Jan2021, and they just had 3 residents, who were positive for COVID, so she wanted to report it in case there was data to look at, to see if they got a bad batch, or was this something that was happening frequently. The second dose scheduled 30 days after the first. The patient underwent lab tests and procedures which included Covid test: positive on 03Feb2021. Outcome of the events was not recovered.  information on the Lot/Batch number has been requested. ; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product comirnaty  to the reported 'COVID 19' cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021162208 same drug and event, different patients;US-PFIZER INC-2021162196 same drug and event, different patients
hx of febrile sz on 7MAR99 & ? sl ear infect;
Lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 05Feb2021 14:00 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose: 1st, Time: 14:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 15Jan2021, for COVID-19 immunisation, reaction(s): "Diarrhea". The following information was reported: LETHARGY (non-serious) with onset 06Feb2021 09:00, outcome "recovered" (07Feb2021), described as "Lethargic". Therapeutic measures were taken as a result of lethargy.  Additional information: The patient had no prior vaccinations. The patient did not undergo relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received FLUARIX QUADRIVALENT (batch number DJ395, expiry date 30th June 2015). Previously administered products included influenza vaccination with an associated reaction of pain in extremity (for 6 months (see case US2015GSK039815)). Concurrent medical conditions included penicillin allergy, drug allergy and iodine allergy. On 5th December 2014, the patient received FLUARIX QUADRIVALENT 1 ml. On 5th December 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm, shoulder pain and injection site reaction. On an unknown date, the outcome of the pain in arm, shoulder pain and injectio site reaction were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, shoulder pain and injection site reaction to be related to FLUARIX QUADRIVALENT.
swelling & redness @ site of inject that extends to shoulder; elevated fever-arm hot to touch;
a prefilled syringe VAQTA's finger flange was broken and a nurse's finger was cut.; a prefilled syringe VAQTA's finger flange was broken and a nurse's finger was cut.; This spontaneous report was received from an office manager regarding a female patient (reported as nurse) of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAY-2023, a vaccine of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, lot #X004813, expiration date: 28-JUL-2024 had the finger flange broken (Syringe issue) and a nurse's (the patient) finger was cut (Skin laceration). Product Quality Complaint (PQC) was filed. The syringe was broken into 2 o more pieces, it was stated that it was possible that the syringe was broken while the nurse was administering the vaccine, and the syringe tray was intact and undamaged on receipt. It was not difficult trying to attach the syringe needle to the syringe, the syringe tip cap was attached properly prior to use, the product was administered, and the cellophane cover of the syringe tray was intact and completely sealed. On 12-MAY-2023, it was reported that the product was returned. At the time of reporting, the outcome of skin laceration was not provided.   The causal relationship between skin laceration and hepatitis a vaccine, inactivated (VAQTA) was unknown.  This is one of two cases received from the same reporter. ; Sender's Comments:  US-009507513-2305USA002045:
This spontaneous report was received from a nurse refers to a 6 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
A little headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "A little headache".  Follow-up (17Dec2021): 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.
Received 3 vaccinations about 1145hrs. Within 75 minutes returned to clinic with hives to axilla bilaterally, to abdomen, and to popliteal fossa. Was given 1 tsp of Claritin children's syrup at return to office and prescription for orapred. Advised to use benadryl for itching. Follow-up phone call 2 hr after leaving office, father states child sleeping after cool bath; no trouble breathing and lessing of rash, despite not having given orapred or benadryl.
BODY ACHE; SLEPT ALL DAY; FEVER; TIREDNESS; COLD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On 25-MAY-2021, the subject experienced cold. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced body ache. On 26-MAY-2021, the subject experienced slept all day. On 26-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.9 (Unit not reported). The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, and fever on MAY-2021, and slept all day on 27-MAY-2021, had not recovered from cold, and the outcome of tiredness was not reported. This report was non-serious.
I felt great after my vaccine until midnight that same day.  My legs from the knees down including my feet were painfully cold as if they were on dry ice.  I didn't get much sleep that night, but the next morning at 2:00 a.m. the pain was gone.  I was just extremely fatigued which was a symptom I expected.  I don't know what to think of the first symptom but wanted you to know.  Thank you.
Chills, Fatigue, Bone and Muscle Pain, 3 days severe then nerve pain started on April 3, Back of Head, Hands, moved to Left Back, moved to under left arm and left chest. Severe.
Received second dose yesterday, 101 fever yesterday dropped to "99.1" this morning; This is a spontaneous report from a contactable consumer. A 67-year old female patient received secondo dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration on 26Feb2021 ( at the age of 67-year old) at single dose for Covid-19 immunization. Relevant medical history and concomitant medications were not reported. Historical vaccination included first dose of same vaccine, on an unknown date. On 26Feb2021 the patient experienced 101 fever that dropped to 99.1 in the morning of the next day. The outcome of the event was recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
1. room spinning dizziness on Sunday, March 7th, at 5:30 PM. Lasted for about 3 minutes. 2.  same dizziness  but shorter duration 3 times  on March 12th, at 5:30 pm and even shorter at about 8:30 pm.
01-13-12 redness at injection site  01-15-12 increase in local redness and tenderness, also fever 101. Went to ER, was DX with cellulitis and admitted for antibodic therapy
Patient had flu shot in the arm 10A by 1130A he had chills, fever, body aches, SOB. Cough, congestion - mattery eyes.