chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 12-FEB-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M011832 and expiration date of 25-JAN-2018, for prophylaxis.
Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Adverse event) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 15-Jan-2021, the patient started TREPROSTINIL SODIUM (Respiratory) microgram every six hours. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse event) (seriousness criterion medically significant). At the time of the report, VACCINATION COMPLICATION (Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION COMPLICATION (Adverse event) to be possibly related.    No treatment for the event was reported.  The reporter considered the serious adverse event of vaccination complication as not related to IH treprostinil and TD-300/A device. The reporter considered the event likely related to (mRNA-1273) the COVID-19 vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Moderna booster administered on 11/16/21, expired on 11/7/21.  Mistakenly read expiration date at 11/17/21.  No adverse event or outcome to recipient.
A non-serious spontaneous report of nausea, diarrhea, and abdominal pain has been received from a consumer/husband concerning his 38-year-old wife, subsequent to H1N1. The patient's medical history and concomitant medications were not provided. On 24-Oct-2009, the patient received H1N1. Several hours after the patient received the vaccine, she experienced nausea, diarrhea and abdominal pain which lasted for four hours. The events resolved.
Received 2 mo vaccines at 11 AM on 7/22/09. Returned to clinic at 6:15 PM stating "(R) leg swollen & painful when touched". Examined by NP who assessed a small lump under skin on upper (R) thigh without erythema or warmth.
FEELING STUFFY; SLEEPING A LOT; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included hysterectomy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. On 04-APR-2021, the subject experienced feeling stuffy. On 04-APR-2021, the subject experienced sleeping a lot. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: antimony potassium tartrate/papaver somniferum tincture/terpin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling stuffy, sleeping a lot, headache, and nausea on 05-APR-2021. This report was non-serious.
This medically confirmed report (via distributor: 1011USA00229; initial receipt 01-NOV-2010) concerns a 70-year-old female patient. On 25-OCT-2010, the patient received an expired dose of H1N1 (Lot: 00249711A; Expiry: 30-JUN-2010) intramuscularly in the left deltoid, at a dose of 0.5 ml, for vaccination. The outcome is unknown.
This case was reported by a pharmacist and described the occurrence of influenza in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline).  On an unspecified date in 2007, the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced influenza and lack of efficacy.  The pharmacist did not have all the details regarding the event, but did confirm at least two weeks or more had passed since the administration of Fluarix.  Relevant test results included a "quick flu test" that diagnosed the subject with the flu.  At the time of reporting the outcome of the events were unspecified.
Woke up at midnight (approximately 8 hrs after injection) with uncontrollable  chills/shaking/shivers that lasted at least 10 minutes, before subsiding on their own.
Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1 am on 3/5/21.  Fever has dropped to 100 as of 4 pm. Severe headache persists. Advil every 6-7 hours, fluids regularly
Information has been received from a registered nurse concerning a 69 year old male with arrhythmia and bipolar disorder and a history of myocardial infarction and no allergies who on approximately 29-OCT-2007 was vaccinated with a dose of zoster vaccine live(Oka/Merck). Concomitant therapy included cyclophosphamide (+) doxorubicin, blood pressure medication, stomach medication and bipolar medication. On 09-NOV-2007 the patient developed shingles. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Vaccine 1/4 Left arm, ED visit 1/5 due to dizziness, light headed, chills, HA, fever went up to 102.0, almost passed out; oxygen given, HR rate went up to 230, started to have convulsions, o2 sats down, RR 70, given ativan for convulsions; Follow up with Care Spot 1/; MMI 1/13
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On an unspecified date in October 2014 (also reported as a week and a half ago) the patient was vaccinated with ZOSTAVAX (route, dose, frequency and lot # not reported). It was reported that the patient developed dermatomal rash "that looked like shingles" on an unspecified date in October 2014. The outcome of the event and relatedness between the event and ZOSTAVAX were not reported. There was no treatment given for the event. Additional information has been requested.
pt recvd vax; exp itching & conjunctival injection; given epi & dph
ACHY; BRAIN FOG; SORE ARM; HEADACHE; This spontaneous report received from a consumer concerned a female 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: Unk) 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 achy. On MAR-2021, the subject experienced brain fog. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, brain fog, sore arm, and headache on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210417733 and 20210416282.
Patient's mother reports that patient broke out in hives and a red rash from neck to toes after receiving DTaP, Hep B, IPV, HIB, and Prevnar.
Right after the vaccination, within 10 minutes I started to feel pressure in my left arm down to my wrist.  I also felt weakness in both legs. I went home and symptoms lingered and remained for over a week. Muscle weakness will come and go .  I was driving in my car and I felt anxious and my chest very heavy and difficulty breathing.  I stopped the car and was fortunate to be parked next to a fire department.  They put me in an ambulance and checked my blood pressure which was high.  They monitored me until my bp went down to the normal range and they allowed me to go home.  For the next 6 days, I felt a  constant pressure in my arm .  I went to Urgent Care to seek care for the pressure on my arm.  They did chest x ray and EKG- everything came back normal and to follow up with PCP.  I have an appt to see my PCP.  Currently I still have pressure/tension originating from left armpit to underneath arm all the way to wrist.
Vomiting x 2 days, body ache, fever x 2 days, headache,
Pt to immunization for smallpox vaccination follow up. Left upper arm (smallpox site) inflammed with axillary area sensitive to palpations. Redness (erythema) noted around lateral border of the pts upper left arm. Pt reports left shoulder pain also. Pt reports pain level is constant 5/10. Pt reports taking Tylenol for pain management on 22 July 2015 @2200.
Pt developed macular rash all over body 11 days after receiving MMR, low grade fever otherwise healthy.
Rash that starts at injection site and spreads throughout the body, across shoulder, up into face and down torso; Rash that starts at injection site and spreads throughout the body, across shoulder, up into face and down torso; Many raised itchy bumps, that look chicken pox like; Many raised itchy bumps, that look chicken pox like; Sensation of 'skin crawling'; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 15:30 (at the age of 44-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 15:15 (at the age of 44-years-old), as single doses for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient had been tested for COVID-19 but she was not diagnosed with COVID-19. On 10Mar2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was found to be negative. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received sumatriptan succinate (IMITREX) on an unknown date and experienced drug allergy. On 03Apr2021 at 00:00, the patient experienced rash that started at injection site and that spread throughout the body, across shoulder, up into face and down torso. The patient also experienced many raised itchy bumps, that looked chicken pox like and the patient had sensation of 'skin crawling'. The patient had same effect for both doses. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with topical steroid (unspecified). The clinical outcome of the events rash that starts at injection site and spreads throughout the body, across shoulder up into face and down torso, many raised itchy bumps, that look chicken pox like and sensation of 'skin crawling" was recovered on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 49 years, 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pemphigus Vulgaris" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Hard of Hearing" (unspecified if ongoing); "Mastoidectomy" (unspecified if ongoing); "Eustachian Tube Dysfunction" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL], start date: 02Jan2017, stop date: 02Jan2023; CYMBALTA, start date: 01Apr2022, stop date: 15Jan2023; CELEBREX, start date: 01Apr2022, stop date: 15Jan2023. Past drug history included: Neomycin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6 hours after stomach pain, fever, body aches, chills, 12 hours vomiting, fever, chills, welt below site hard as rock and painful 24 hours pain, body aches, intermittent fever, stomach pain, kidney pain unable to maintain hydration brown urine
Achy with low grade fever. The next day developed a a spotty red rash. Rash started on torso below the armpits and back. It is spreading to cover the entire torso and down to the groin and upper thighs.
Bell's Palsy symptoms; Right sided facial paralysis; Inability to close the right eye; Right sided facial numbness; Lop-sided smile; Patient received Pfizer COVID vaccine 01Mar2021,15Mar2021; This is a spontaneous report from a contactable Nurse. A 45-year-old female patient received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE for COVID-19 immunization and received POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on 26Jul2021. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 on 01Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. On 30Jul2021, patient experienced Bells Palsy symptoms, right sided facial paralysis, inability to close the right eye, right sided facial numbness, and lop-sided smile. The patient was treated with Valacyclovir 1000mg TID for 5 days, and Medrol dose pack 4 mg X 6 days. The outcome of event Inappropriate schedule of vaccine administered was unknown and for other events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the event bells palsy and facial paralysis and the suspect drug BNT162B2  cannot be ruled out. 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.
Pt received PNEUMOVAX vaccine on 9/4/24, after which he developed LUE swelling, redness, inflammation at injection site and reaching to elbow area. Pt presented for urgent care visit, was treated for cellulitis with cephalexin 500mg QID x 10 days. Subjective fever at injection site.
In December 2022 I had an annual eye doctor appointment and they found increased eye pressure which if left untreated can turn to glaucoma.  I had a follow-up appointment in March of 2023 and was prescribed eye drops, Timolol Maleate.  My vision had worsened since my last exam, and I had had some blurry vision and glaring but this may be due to age.
Patient received his first dose of Covid vaccine on Jan. 30, 2021. On Jan 31, 2021 at 6:08 AM, patient noted unresponsive per facility. Code blue was called and 911 dispatched. He expired in the ER.
AEs for 49 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (AEs for 49 patients) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (AEs for 49 patients). At the time of the report, VACCINATION COMPLICATION (AEs for 49 patients) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Information has been received from a physician assistant concerning a female with ovarian cyst and kidney stone who in August 2008, was vaccinated with GARDASIL. Concomitant therapy included OCELLA. The physician assistant reported that the patient received the 3rd dose of GARDASIL on 16-JUN-2009. Subsequently the patient and passed out, was dizzy and had a headache. The patient was fine when she left the office and it was unknown when the passing out and dizziness occurred. The patient did complain of a headache the day of visit before the third dose of GARDASIL was given. The patient saw a report on television and called the office to report what happened. The physician did not feel this was related to GARDASIL since the patient had a headache prior to receiving the 3rd dose. The 1st and 2nd doses were given by a different office. Subsequently, the patient recovered from passed out, dizziness, and headache. It was indicated that the patient was referred to see a neurologist. The patient sought medical attention, called and visited a physician on 19-AUG-2009. On an unknown date a CAT Scan was performed which was normal. Additional information has been requested.
05/31/2003 approximately 7pm after gardening felt very tired and had abrupt onset weakness and joint pain. 17th day post smallpox vaccine. 06/02/2003 seen in ER for pain and weakness, Dx with UT given Roaphin IM, antibiotic and anti inflammatory. 06/03/2003 seen by primary care physician. Rx: Lomcette Q 4-6 hours PRN pain 06/04/03 seen in ER with c/o severe joint pain relieved in ER with Prednisone and Torodol. Dx  home with Rx Zitacycline and Pnidnisone. 06/05/2003 pain continued to be severe in joints and has weakness in arms and legs. 06/05/03 @ 10:32am  EOS 4 Sed Rate 98
Sore Arm for 6 days, migraine the next day only in the morning, chills not fever off and on, stomach ache,
Reprted as "shortness of breath, a red bumpy rash that I could hardly stop itching, and I had the rash for a couple of days".  Rash allegedly intermittent for three to four days.  Respiratory distress continued intermittently for about five days.  Used P.O. Benadryl for rash and Albuterol inhaler and nebulizer for respiratory symptoms.
Shortly after Pfizer Covid-19 vaccine I developed blisters in my mouth - after second vaccine I got a persistent sore throat and more blisters. Evaluation by dentist and several doctors with no resolution
After my 1st dose, within 48 hours, my middle finger started to hurt towards the tip, mostly at night. 5 days later my right middle finger did the same. During this time I've felt my right big toe fee; After my 1st dose, within 48 hours, my middle finger started to hurt towards the tip, mostly at night. 5 days later my right middle finger did the same. During this time I've felt my right big toe fee; After my 1st dose, within 48 hours, my middle finger started to hurt towards the tip, mostly at night. 5 days later my right middle finger did the same. During this time I've felt my right big toe fee; After my 1st dose, within 48 hours, my middle finger started to hurt towards the tip, mostly at night. 5 days later my right middle finger did the same. During this time I've felt my right big toe fee; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 11Mar2021 at 10:45 AM (at the age of 40-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included occipital neuralgia from an unknown date and unknown if ongoing. Concomitant medications included trazodone (TRAZODONE) and gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Patient had no known allergies. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products reported as no. Vaccine Facility, ethnicity and race information reported as available. After 1st dose, within 48 hours on 13Mar2021 at 20:00, patients middle finger started to hurt towards the tip, mostly at night and 5 days later right middle finger did the same during this time patient felt right big toe feeling numb and the past 2 weeks right hand itches and patient had a raised rash. Patient never had these symptoms before the vaccine. The pain was definitely bearable, but patient thought it was worth reporting. Seriousness criteria Results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect all were reported as no. Adverse event resulted in: Doctor or other health care professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination the patient did not tested for COVID. The outcome of the events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
09/18/2010 - Donor reported today that he developed swelling and redness to the area, and hurting more. Sx developed on 09/16/10 approximately 09:00 PM and is a little worse every day. Upon examination of his right arm, the deltoid has a firm nodule palpated that was approximately one inch width, skin w/tinted - more pinkish-reddish area 1 3/4" x 2 1/16" perimeter. Skin was warmer to touch the area w/comparison to his left arm. Had a small pinkish/red pin point area that resemble a pimple - donor questioned if this was the area of his injection and stated, "no". Skin w/o any open areas, no red streaks, or pustule. Denied any other s/s. Denied previous reactions or sensitivity to previous Tetanus injections that he received in 02/2010, 09/2009, and ? 2005 d/t injury.
Headache, Myalgia, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritis, chills Narrative:  Other Relevant History: