chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presents with her mother s/p receiving varicella in left arm SQ approximately 2 hours ago.  She states she is having numbness of bilateral cheeks and states she feels "heaviness when [she] breathes".  Patient is alert and appears in no acute distress.  She is able to accurately depict sensation of left vs right cheek upon light touch.  Tongue/cheeks do not appear swollen on visual exam and posterior oropharynx is patent, no swelling or enlarged tonsils noted.  Vital signs obtained at approximately 1735 are as follows: 103/63 BP, 78 bpm, O2 sat at 99%.  She denies chest pain, difficulty breathing, tongue swelling, feeling of throat closing, or dizziness.  Educated her on expected side effects from vaccines.  Recommended she f/u with ER if she starts developing chest pain, difficulty breathing, swelling of tongue, feeling of throat closure, dizziness, or fainting.  Advised that her symptoms could be coincidental and unrelated to receiving vaccine.  Recommended she closely monitor her symptoms and to f/u with urgent care/ER if symptoms do not improve.  Recommended she try taking an anti-histamine OTC.  She verbalized understanding and all questions were answered.
after the 2nd dose he felt achy the following day; after the 2nd dose he had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after the 2nd dose he had a sore arm) and PAIN (after the 2nd dose he felt achy the following day) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], NIACIN, TRAMADOL HYDROCHLORIDE (DOLUS) and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (after the 2nd dose he had a sore arm). On 07-Mar-2021, the patient experienced PAIN (after the 2nd dose he felt achy the following day). On 07-Mar-2021, PAIN IN EXTREMITY (after the 2nd dose he had a sore arm) had resolved. On 08-Mar-2021, PAIN (after the 2nd dose he felt achy the following day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Alanine aminotransferase: 79 (High) Elevated. On 14-Apr-2021, Aspartate aminotransferase: 49 (High) Elevated.         Treatment included Ibuprofen.
Narrative:  Patient received two doses of covid vaccine. Patient found deceased in home approx. one month later. no further documentation of cause of death. patient with active metastatic disease.
Syncope  Vital Signs: BP 110/80 HR 82 O2Sat 95%  Skin Signs: Clammy, diaphoretic, Other - Pale  Circulation: Cap refill <2sec  Initial Treatment: Raised legs, patient had moved from original position  911 called - denied  7:25 PM:  Vital Signs: BP 110/77 HR 76 Resp 16 O2Sat 97%  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Laying down on cot, Juice box  7:41 PM  BP 110/75  Notes:  Provider called to patient side due to patient becoming unresponsive in chair. Patient assisted to floor and noted to be unresponsive. Pale, diaphoretic, and pupils dilated. Patient did not initially have a palpable pulse, however, initiate CPR patient became responsive. AOx3. EMS arrived and evaluated. Home with wife.
Patient received Pneumonia Vaccine in Rt Deltoid, and Influenza vaccine in Left Deltoid on 10/27/05.  By AM of 10/28/05 Rt. Arm had edema and redness below site to elbow.  Patients Privent MD instructed to talk Tylenol every 3 hours and apply ice for next 24-48 hours.       By 10/31/05 Redness relieved edema minimal.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored on an unspecified date. No concomitant medications were reported. The dose was administered according to the prescribing information. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Moderna vaccine. Extreme pain in my bones. It was unbearable. Stopped on 12/3/2021 around 9 am. Paralysis for around 20 minutes. I could not move at all. Ended 2:20 am. 103 fever broke around 6 am on 12/3/2021. Major vaginal pain. I felt like my ovaries were going to burst for about 4 hours from 1:43 am - 5:30. My period also did not come for this month.
CHILLS; THROWING UP; This spontaneous report received from a consumer (patient's wife) concerned a male of unspecified age, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (unspecified manufacturer). (Dose number in series 1)  The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiration date were not reported) dose was not reported, 1 total administered on 09-NOV-2021 for prophylactic vaccination.(Dose number in series 2) The batch number was not reported and has been requested. Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 09-NOV-2021 for an unspecified indication. No concomitant medications were reported.   On 09-NOV-2021 in the morning, the patient got the flu shot (influenza vaccine) then in afternoon he got the booster dose of the Johnson and Johnson COVID vaccine. At the time of report, the patient was at home and had chills and was throwing up.(Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the chills and throwing up was not reported.  This report was non-serious.
This is a spontaneous report from a non-contactable consumer. A patient of unspecified age ethnicity and gender received pneumococcal PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced mild stroke on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Started as localized tingling/pins and needle sensation by injection site approximately 4 hours after initial injection.; the sensation spread to all extremities (arms, hands, legs, and feet).; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) via an unspecified route of administration on 17Jan2021 at 15:00 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not receive any concomitant medications. The patient previously received cefprozil (CEFZIL) and vancomycin from unknown dates and experienced allergy. On 17Jan2021 at 19:00, the patient experienced localized tingling/pins and needle sensation by the injection site approximately 4 hours after initial injection. Over the course of the next day the sensation spread to all extremities (arms, hands, legs, and feet). It was three weeks since first dose and sensation had lessened but still felt at times. The patient did not receive any treatment for the events. The outcome of tingling by the injection site and sensation spread to all extremities was not recovered. It was also reported the patient had not been tested for COVID-19 since the vaccine.   No follow-up attempts are needed. No further information is expected.
I woke up with a sore throat followed in the next two days sneezing sinus congestion body aches fever 102.2.
Flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case is linked to cases 2020SA291983, 2020SA291967, 2020SA291968, 2020SA291969, 2020SA291970, 2020SA291971, 2020SA291972, 2020SA291980, 2020SA291973, 2020SA291974, 2020SA291975, 2020SA291976, 2020SA291977, 2020SA291978, 2020SA291979, 2020SA291981, 2020SA291982, 2020SA291966 and 2020SA291965.  This case involves a patient (age and gender unspecified) who had flu (influenza) after received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Consumer have had the flu shot twice in life, and both time got the flu. The only two times consumer have ever had it.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  There will be no information available on the batch number for this case..
3:00 a.m. (11 hrs after injection) I was awakened from sleep by uncontrollable shivers and chills that lasted over 2 hours.  By 6:00 I had a fever and was aching all over.  I finally went back to sleep until around 9:30.  Fever broke and I ate almost all of a piece of toast, though I wasn't hungry really and couldn't taste it much.  I slept a total of 17 hours from 6:00 a.m. Saturday to 6:00 a.m. Sunday.  Still achy, feverish, and tired on Sunday.  Rested most of the day.  Monday morning I woke up with icepick headaches in the top left side of my head and the left temple.  These were frequent and intense throughout the day.  No fever but extreme fatigue and still achy in joints.  Injection site is a hard knot and is warm.  Headaches continued Tuesday (yesterday) in same locations in my head.  Still can't taste much, and now have 2 fever blisters on my lips and sores inside on the roof of my mouth.  Wednesday (today) I finally have not had any of the headaches and am slowly regaining my energy.  Still have the sore inside my mouth and can't taste food as it should taste.  Feel much better but not 100% yet.
Temperature 103 degrees, headache, tiredness, dizzy, tightness in chest. Onset 8/21/02 about 9pm mother gave Tylenol.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 05Apr2022 at 01:45 as dose 4 (booster), single (Lot number: FK9893) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "Known allergies: probable penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: Jan2010, stop date: 05May2022; SYNTHROID, start date: Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details product=COVID 19 Treatment, brand Pfizer Paxlovid, treatment start date=05May2022, treatment stop date 09May2022, For Treatment of COVID-19.
I received my 1st dose on 2/26, but I still have intermittent level 2-3 pain in the left upper arm where I was given the shot.  I think eventually it will go away, but since my 2nd shot is coming up and it has been almost a month, I thought I should mention it to you and ask whether I should mention it to the CDC as a reaction.  I think this is just a result of the injection itself and not of the vaccine.  But I have never had such a lingering pain before from an injection and so I raise the question.
About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6199), via an unspecified route of administration, on 16Mar2021 at 10:45 AM (at the age of 47-year-old) at single dose for COVID-19 immunization, administered at clinic. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN5318), administered on 24Feb2021 at 10:45 AM (at the age of 47-year-old) at single dose for COVID-19 immunization. No relevant medical history was provided. Relevant concomitant medications included escitalopram, allopurinol, vitamin D NOS, and folic acid. About 02:30 am on 17Mar2021, he began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17Mar2021, they resolved with the use of ibuprofen.   No follow-up attempts are needed. No further information is expected
booster; COVID positive test on 13Dec, had 2 shot series and booster; COVID positive test on 13Dec, had 2 shot series and booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. 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: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "not recovered" and all described as "COVID positive test on 13Dec, had 2 shot series and booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) posative. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse (R.N.) concerning a 63 year old female with asthma and rhinitis allergic and penicillin allergy who on 21-OCT-2010 was intramuscularly vaccinated with a dose of PNEUMOVAX 23 (lot number 665917/1341Y). Concomitant therapy included ADVAIR, albuterol and ALLEGRA. The reporter stated that on 22-OCT-2010 a red, swollen area "about the size of a golf ball" developed at the injection site. "It felt like a huge knot was in there." Sometime after 23-OCT-2010 the patient recovered. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report was received from a physician referring to a 16-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 31-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Lightheaded; Tiredness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route in left arm on 19Mar2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included heart failure, hypertension, afib (atrial fibrillation) and Depakote allergy. Past drug history included Depakote from an unspecified date. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), MOBIC, furosemide (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and NORVAS taken within two weeks of vaccination for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 15:30, the patient experienced tiredness, lightheaded and nausea. No treatment was received for the events. The clinical outcome of tiredness, lightheaded and nausea was recovering.   Information about lot number cannot be obtained. No further information is expected.
Patient in the emergency department after suffering a fall the day before. She was subsequently found to have a compression fracture at L4. She was admitted for new lumbar fracture after a ground-level fall. Patient was also found to be COVID-19 positive. She was discharged 4 days later to home in stable condition.
A little more than 24 hours after the shot, I experienced severe back pain and severe pain in what I called my adenoids; A little more than 24 hours after the shot, I experienced severe back pain and severe pain in what I called my adenoids; Get a bad cold; Stuffed head for two days; Last night I experienced trouble Breathing.; Asthma; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: EN6208, Expiry date: unknown) via an unspecified route of administration, administered in arm right on 18Mar2021 12:00 (age at vaccination: 59-years-old) as dose 1, single for COVID-19 immunization (facility). Medical history included asthma and hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrocodone taken for limb injury. On 19Mar2021 13:00, patient experienced severe back pain and severe pain in what she called her adenoids which was the first sign that she was going to get a bad cold. Stuffed head for two days then last night she experienced trouble breathing. She had diagnosed with asthma and she had asthma medicines there which she took. Patient had no Covid prior and after the vaccine and no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 and not tested for covid post vaccination. Patient received prednisone, symbicort and albuterol prevented a trip to the hospital for the treatment of the event asthma. Patient did not take any treatment for the events severe back pain, severe pain, bad cold, stuffed head and trouble breathing. The outcome of the events was reported as resolving.
very painful; swollen; big red; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included mild intermittent asthma. The patient had PEG and poly sorbate allergy test and the result found to be negative after the reaction to dose 1 in unknown date in 2021. Concomitant medication included vitamin d (MANUFACTURER UNKNOWN), Multi vitamin (MANUFACTURER UNKNOWN), Omega 3 (MANUFACTURER UNKNOWN), ALLEGRA, iron (MANUFACTURER UNKNOWN), Probiotic (MANUFACTURER UNKNOWN) for unknown indication. The patient had a history of sensitivity to erythromycin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received vaccine on Wednesday, on Friday night, on 12Mar2021 at 21:45, the patient experienced a big red, mottled, swollen, hot circle, which was very painful but not itchy. The patients dark place remained and was crackling on dermal surface. Her pain subsided 5 full days out and dark patch was remained at the time of report. Therapeutic measures was taken as results of events and included the treatment with tylenol and applied cold compress. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events swelling, redness and pain was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Otherwise healthy adolescent male with Intractable Headache and HyperEmesis. 10/22/21 to Urgent care- Dx Migraine Headache; 10/23/21 Admitted to Neuro ICU through ER for Large Cerebellar Stroke with Mass Effect on MRI. EVD drain placed for approximately 2 weeks. Discharged 11/8/21.
flublok has been administered to a 13 year old patient with no AE; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 13 years old male patient who received 0.5 ml dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: unknown, expiry date: unknown, Pre-filled syringe) via un unknown route and site on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.