chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my covid 19 2nd dose vaccine of pfizer on October 29th around 3:00 pm in the afternoon. Sunday afternoon on November 7th I started having left eye pain, Throughout the evening my vision started going blurry and then completely black. I received medical attention on Monday November 8th I was then referred to the ER for an MRI. I went to the Medical Center and received an MRI, I was discharged at 2:30 in the morning on Tuesday November 16th. On November 16th around 10 am in the morning I got a call from the Medical Center saying I needed to come back to be admitted for optic neuritis and would need IV steroids. I went to the ER and was admitted from Tuesday to Thursday. I received multiple IV steroid infusions, multiple lab tests, lumbar puncture, repeat MRI. At Discharge my vision was still not completely back but was starting to come back.
little bumps all over her face and body which are like measles; swollen eyes; watery eyes; Runny nose; Sneezing; Congestion on her chest; Dry eye socket; dry eye socket with crust on eyelashes; Headache; allergic reaction for a week/allergic reactions keep coming back; Ear feels full; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy. Concomitant products included LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced EAR DISCOMFORT (Ear feels full). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back). On an unknown date, the patient experienced PULMONARY CONGESTION (Congestion on her chest) (seriousness criterion medically significant), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (Congestion on her chest), HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), EAR DISCOMFORT (Ear feels full), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache) had not resolved.            Treatments provided were 25mg diphenhydramine, 16mg Hydrocortisone cream, Metoprolol steroid, and Doxycycline for 7 days given by her HCP. Action taken with mRNA in respect to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.   This case was linked to MOD-2021-095202 (Patient Link); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.
Patient received Tdap in R Deltoid IM and Hepatitis B vaccine in L Deltoid. In approximately 5 minutes post vaccination, the patient complained that the right foot and leg was getting numb and tingling. Patient remained in clinic for approx. 30 minutes.  Vital signs were WNL.  Patient reported that he felt like his eye were dilated (pupils were not dilated). The numbness/tingling remained in the Rt. lower extremity and this did improve but did not fully resolve prior to his leaving the clinic. Nurse spoke with the patient on 5/12/11 and patient reported that symptoms fully resolved.
multiple myeloma; This is a spontaneous report from a contactable consumer (patient's daughter). An 80-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient had both sets of Pfizer and was fine and had no reaction period. A couple weeks later, he was diagnosed with multiple myeloma. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Headache; Fatigue; Achy muscles; First dose on 11Jan2021 and second dose on 22Feb2021; This is a spontaneous report from a contactable other HCP (Patient). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in right arm on 22Feb2021 at 11:00 (at the age of 46 years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included hypertension and covid-19. The patient had no known allergies. The concomitant medication included ibuprofen. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- Unknown) via an unspecified route of administration in right arm on 11Jan2021 at 11:00 as dose 1, single for COVID-19 immunization. The vaccination facility type reported as nursing home/senior living facility. There was no other vaccine administered in four weeks. The patient was not tested for COVID post vaccination. The patient experienced headache, fatigue, achy muscles on 23Feb2021 at 13:00 and on 22Feb2021 "First dose on 11Jan2021 and second dose on 22Feb2021". No treatment was received for adverse events. The clinical outcome of events headache, fatigue, achy muscles was recovering.  Information about lot number/batch number has been requested.  Follow-up attempts completed. No further information expected.
Pfizer / BioNTech Dose Number: 1/Dose Number: 2 and Evusheld Dose Number: 1; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203), in left arm and on 01Apr2021 as dose 2, single (Lot number: EN5318) at the age of 67 years, in left arm for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 08Apr2022 as dose 3 (booster), single (Lot number: AZ210060), in left gluteus medius for covid-19 immunisation. The patient's relevant medical history included: "lymphoma in remission" (unspecified if ongoing), notes: lymphoma in remission; "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "intussusception" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; LISINOPRIL; FOLIC ACID; LEXAPRO; TYLENOL PM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown", described as "Pfizer / BioNTech Dose Number: 1/Dose Number: 2 and Evusheld Dose Number: 1". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient has no known allergies. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Patient took Paxlovid for COVID 19 Treatment from 12Aug2022 to 16Aug2022 for COVID. The vaccine Cilgavimab & Tixagevimab (Evusheld) location was administered Left buttocks.
Patient reported to the clinic c/o rash and sores that had not healed since vaccination.  Patient stated that he was trying to allow self healing and did not want to report to clinic since he felt he was always at the clinic and thought they would self heal.
This spontaneous report was received from a medical assistant referring to a female patient of  unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL intramuscular injection (lot #, expiration date, dose and route of administration were not reported), then, four months later on an unknown date, a dose (reported as a second dose) of GARDASIL 9 injection (lot #, expiration date, dose and route of administration were not reported) was administered (interchange of vaccine products). No adverse effects were reported. Concomitant therapies were not specified. At the time of the report, the outcome of interchange of vaccine products was unknown. Additional information is not expected since there was not consent from the reporter to be contacted.
one episode of tachycardia.  HR of 150 lasting 3-4 hours.
ACHES; SORE BONES; LOSS OF APPETITE; INABILITY TO WALK; MUSCLE SPASMS RADIATING FROM INJECTION SITE; TENNIS ELBOW WITH GROWTH ON ELBOW; FEVER; SORENESS AT INJECTION SITE; 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 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 an unspecified date, the patient experienced aches, sore bones, loss of appetite, inability to walk, muscle spasms radiating from injection site, tennis elbow with growth on elbow, fever, and soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, sore bones, loss of appetite, inability to walk, soreness at injection site, muscle spasms radiating from injection site and tennis elbow with growth on elbow was not reported. This report was non-serious.
Approximately 5 hrs after vaccine I had a large (half tennis ball) size lump on my leg. It was hot and it was painful. It was not discolored. I went to the ER and was given an ultrasound. They said it was not  a DVT.  They said it was a surface hematoma. It was not discolored and I DID NOT sustain any injury to that area or any other area.  they would not say it was directly related to the vaccine.
Additional information provided medical history, test results and patient demographics. Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old female patient who experienced hard area at the injection site. At 4 months of age, the patient received the second dose on 19-Jan-2009. The patient experienced hard area at the injection site on 23-Jan-2009. The patient recovered. See related case(s): US-WYE-H09136009 (adverse event, non-expedited). No additional information was available at the time of this report.
pt recv vax & following day pt devel swelling the size of a plum on upper arm & exp pain & induration that was relieved by warm compresses;
On 2/6/2021 woke with neck pain and droopy eyelid on the left side of the face. Went to the ER and was diagnosed with Bell's Palsy.
Onset trouble walking described by grandfather-"drunken sailor" after emesis at 05:00 waking patient. Ataxia improved at 24 hrs. then resolved by 48 hrs. Had serous otitis presumed to be otitis media and treated with antibiotic.
Information has been received from a healthcare worker concerning a 17 year old female who on 19-SEP-2008 was vaccinated with a first dose of GARDASIL vaccine  (lot # 661044/0548X) intramuscularly.  On 20-NOV-2008, the patient was vaccinated with a second dose of GARDASIL vaccine (lot # 661764/0650X) intramuscularly.  Secondary suspected therapy included varicella virus vaccine live on 20-NOV-2008.  The patient developed swelling to her eyes after receiving her second dose of GARDASIL vaccine.  The patient had office visit to treat the event.  The patient may have experienced eye swelling after her first dose of GARDASIL vaccine, but was not certain.  At the time of reporting, the patient was recovering from the event.  Additional information has been requested.
Patient developed rash all over body from neck down. Rash got better, then started back up again. Went to Pediatrician on 12/4/21, and got swabs of skin surface. Cultures returned to show Staph infection. Skin has now improved after Antibiotic use.
fatigue, h/a, body aches, t100.9 po, swelling & hives on lt arm;31OCT96 7PM completely resolved by Sunday afternoon, APAP for relief;
Patient with history of 3 COVID vaccines who admitted with altered mental status and pneumonia.  COVID test initially "not detected" upon admission on 11/20/22.  Retesting on 11/29/22 resulted detected.  Issues resolved and patient d/c back to facility.
It was reported that an 18 year old female received a Fluzone UNSP '99-'00 vaccination on 10/26/99. Reportedly, on 10/31/99, the pt developed a generalized red, raised rash. The pt was treated with oral Benadryl by the NP at student health. Pt was no evaluated by a physician. Additional information dated 11/16/99; "Approx. 2-3 days after I reported this reaction, the pt developed additional symptoms which we determined was the cause of the rash, and not the flu vaccine.
patient said 5 days after got flu shot bottom side of arm and down side has red blood type bruising and is very sore. he came in 2 weeks later and said is getting better but still hurts and bruised
Information has been received from a registered nurse (also reported as healthcare worker) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received an improperly stored dose of ROTATEQ (lot# M031802, expiration date 09-NOV-2017; lot# L048854, expiration date 31-AUG-2017; dose unknown) orally. No adverse effects were reported. The vaccines were stored under 49.1 Fahrenheit degree for 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states that she got her flu vaccine and then she began to have decreased hearing in her left ear and rumbling so she went to her doctor.
Began running a temperature of 99.4 to 101.2 for approximately 24 hours.
Developed CLL with no prior history of high white count in established in regular blood test patterns, WBC seem to be about increasing 12% each  4 weeks, took vac in April by the end of June abnormal results if we reverse the 12% to the time of the immunization WBC would have been in normal range if the current % increase could be reversed, had normal bloodwork the year before and normal bloodwork a couple months before when being approved for life insurance
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. No adverse effects reported.
fast heart rate (135), nausea, diarrhea, chills, fever 101.3
shivering; muscle pain; tiredness; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date,received 1st dose).   On 3rd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced shivering, myalgia and tiredness. On an unknown date, the outcome of the shivering, myalgia and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the shivering, myalgia and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  A day before reporteing, the patient received 2nd dose of Shingrix. The reporter wanted to know how long the events were lasted.
Severe confusion, limited ability to communicate orally, rash and blisters on recent sites of application of rivastigmine dermal patches.
Intractable debilitating muscle and joint pain not responding to all medical therapy.  Began with vaccination and worse daily persisting at ten day post vaccination.
Post vax the pt developed diffuse rash, itching, swelling of the eyes, mild wheezing. Temp - 97.9, BP - 120/74, RR - 24, O2 sat - 95%. Pt experienced periorbital edema, macular rash, erythematous, pruritic papules. Treated with Benadryl, Solumedrol, saline.
Heavy, irregular heartbeat after the 1st dose; tenderness in left arm; Chest pain after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Heavy, irregular heartbeat after the 1st dose), CHEST PAIN (Chest pain after the 1st dose) and TENDERNESS (tenderness in left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (Heavy, irregular heartbeat after the 1st dose), CHEST PAIN (Chest pain after the 1st dose) and TENDERNESS (tenderness in left arm). At the time of the report, HEART RATE IRREGULAR (Heavy, irregular heartbeat after the 1st dose), CHEST PAIN (Chest pain after the 1st dose) and TENDERNESS (tenderness in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 11:18 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 11:18 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Patient received booster dose on 12 Feb 2022.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
After varicella vaccine (ProQuad) on 8/31/20, baby had itchy scabs (rash) all over body. Ped attributed it to chickenpox vax.
A bump and a 3 inch rash at the site of administration of the vaccine; A bump and a 3 inch rash at the site of administration of the vaccine; This spontaneous case from  was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849 and expiry date was 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine. The patient did not receive any treatment measures associated with the events.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.   The case was assessed as non-serious.  This case is linked to cases 202004678, 202004696, 202004697, 202004698, 202004700, 202004701, 202004702, 202004703, 202004704, 202004705 and 202004706  due to the same reporter.  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional document received on 12-Jan-2021 from other health professional via The Agency (reference number: SEQW21-00149): Two additional reporters added. No changes in narrative.  Company comment: The patient developed vaccination site mass and vaccination site rash on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related''in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site mass and vaccination site rash on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related''in the safety database for reporting purposes).
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a 13-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 27-Jan-2012, expired FLUMIST was administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.