chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a female registered nurse of unknown age regarding herself. Approximately on an unknown date in 1993 (20 years ago), her arm (affected) was broken. On 03-JUN-2013, the patient was vaccinated with a 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date unspecified), subcutaneously. No concomitant medications were reported. On 03-JUN-2013 (reported as that day), at supper time, pain at the injection site began. She stated that the pain increased and became severe. She stated that she lost mobility in her arm as a result of the pain. She also developed a fever at that time. There was no visible swelling or redness at injection site. She did not seek any medical attention. No lab tests were performed. She took unspecified anti-inflammatory drugs and unspecified antihistamines which improved her pain and arm function. On 10-JUN-2013, the patient recovered from the events. The relatedness for the events was unknown for PNEUMOVAX23. Additional information is not expected.
My son experienced after 2nd vaccine and on Wednesday late afternoon he started getting a rash on his hands and then his eyes started to get puffy.  The next morning, his face were more swollen and rash in hands were very itchy. We gave him some Benadryl. On Friday his eye was shut closed. I took him to the urgent care and they gave him a steroid shot and prescribed steroids and Pepcid for the itchiness.  They gave him a Kenalog injection, Medrol 4mg therapy pack and 5 tablets of Pepcid at the urgent care.  As of today, he still has some rash to his hands but his face is not swollen.
Fever of 102 degrees F and urticarial rash 5 days after DTaP,HIB and PREVNAR vaccine.
pt who recv varivax approx 6 mo p/vax pt devel zoster.
Adverse Event: Bells Palsy. Adverse Event Date 12-21-09. Treatment - unknown.
he had a minor stroke; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's sister) reported that a male patient (reporter's brother) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date in Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter's brother was scheduled to take the 2nd dose of the Pfizer Covid-19 vaccine on 01May2021 (Saturday) however on 19Apr2021 (Monday) he had a minor stroke. Reporter would like to know if her brother can still proceed with the 2nd dose. First dose was given 3 weeks ago. The outcome of the event was unknown.  Information about lot/batch number could not obtained.
patient stated having surgery, a neck fusion, a week ago - before second dose; This spontaneous case was reported by a consumer and describes the occurrence of NECK SURGERY (patient stated having surgery, a neck fusion, a week ago - before second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concomitant products included CYCLOBENZAPRINE, BENAZEPRIL and METOPROLOL for an unknown indication.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK SURGERY (patient stated having surgery, a neck fusion, a week ago - before second dose). At the time of the report, NECK SURGERY (patient stated having surgery, a neck fusion, a week ago - before second dose) outcome was unknown.            Treatment information was not provided by the reporter.  Company Comment: Very limited information regarding the event has been provided at this time. Patient stated that she had no adverse events after the first dose. Further information has been requested.   This case was linked to MOD-2021-272329 (Patient Link).; Sender's Comments: Very limited information regarding the event has been provided at this time. Patient stated that she had no adverse events after the first dose. Further information has been requested.
Ringing in ears started after injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 13:00 (Lot number: FE3590) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Other medical history: Seasonal allergies; "Known allergies: Sulfur" (unspecified if ongoing); "Known allergies: metals" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN. Past drug history included: Nubain, reaction(s): "Known allergies: Nubain". Vaccination history included: Bnt162b2 (previous dose product: COVID 19, brand: Pfizer , lot number: EW0150, administration time: 02:00 PM, dose number: 2, dose vaccine location: Left arm), administration date: 09Apr2021, when the patient was 61 years old, for Covid-19 Immunization; Bnt162b2 (previous dose product: COVID 19, brand: Pfizer Covid Vaccine, lot number: ER8727 , dose administration time: 03:45 PM, dose number: 1, dose vaccine location: Left arm), administration date: 19Mar2021, when the patient was 61 years old, for Covid-19 Immunization.  The following information was reported: TINNITUS (non-serious) with onset 09Oct2021 12:00, outcome "not recovered", described as "Ringing in ears started after injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Facility type vaccine was reported as Pharmacy or Drug Store. Patient did not receive any other vaccines in four weeks. Ringing in ears started 30 hrs after injection. Patient had no covid prior vaccination and post vaccination patient tested covid. Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: PCR. Covid test date: 30Nov2021 with unknown result. Event was assessed as non-serious.  Follow-up attempts completed. No further information expected.
Case number PHEH2013US022856 is an initial spontaneous report from the pharmacist received on 29 OCT 2013. This report refers to a 09-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly on 28 OCT 2013. No adverse event reported following this medication error (inappropriate age of vaccine administration).
Arm swollen from collarbone to elbow. Pt reports minimal pain, just swelling. At this point (10/21/08 1pm) symptoms still unresolved.
-Muscles Spasms (lasted about 15 minutes) -Fever -Chills (including chattering teeth) -Diarrhea -Vomiting -Sore Throat -Headache -Fatigue -Stomachache -Loss of appetite -Shortness of breath
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot# N023328, expiration date 22-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced two temperature excursions. Firstly, the vaccine was exposed to temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 120 hours (5 days) and secondly to temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 48 hours (2 days). Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Severe headache, severe epigastric pain with vomiting. Rapid heartbeat all night long, swelling of eyes
This patient had swollen cervical and occipital lymph glands, fever, and myalgias.
cough after two months it stopped, and started back; had booster shot in 2021; had booster shot in 2021; This is a solicited report based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4085446-00).  A contactable consumer (patient herself) reported a 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) (at the age of 64-years-old) as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine via an unspecified route of administration on 2021 (Batch/Lot number was not reported), as single dose for immunization and adalimumab (HUMIRA solution for injection in pre-filled syringe), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, as citrate free for moderate to severe rheumatoid arthritis. Medical history included asthma and rheumatoid arthritis. Concomitant medication included hydrocortisone (CORTIZONE) taken for unknown indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 64-years-old); both intramuscular and for COVID-19 immunisation and experienced bad foot problems lost all functions of toes, nine toe fracture, dietary restrictions, did not felt great with grains, dark veggies, cough, pain in hip, angst in body sounds like body was fighting itself. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had booster shot in 2021 and got flu shot. In 2021, she had cough after two months it stopped and started back. She takes inhaler for life history of asthma. The action taken in response to the events for adalimumab was unknown. Outcome of event was not recovered. The reporter assessed the event as Other medically important condition.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event of cough and with Humira (Adalimumab) was a reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Cough" and suspected vaccine BNT162B2 cannot be completely excluded.  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.
States he started feeling hot lowered to ground. Did hit his head. States this has happened in the past with draws. Has allergies to PCN as hives Awake, alert and oriented x 3 99%  O2 Sat, RR 18, BP 156/86, HR 88 Feels better while sitting in observation Only medical history of hypertension, is not taking meds
On Friday 11/21/14 around 4:00 AM, woke up with pain/redness/swelling to left arm. Throughout the course of the day, pain/swelling/redness worsen. Felt hot/cold. Also extreme fatigue. ER visit around 10:00 PM 11/21/14. Temp reported 99.1 degrees F. Dx with acute cellulitis. Tx KEFLEX 500 mg BID 10 day. Pain reached from shoulder blade to elbow. Along with redness/swelling.
Client left message on immunization nurses line 04/13/2021 stating he received J&J vaccine on Friday, and is having a severe reaction, can't eat, drink, breathing problems, hasn't been able to pee for 4-5 days, throwing up and severe diarrhea, and he can't stand.  I returned his call and he verbalized all issues above and also said his legs, arms and hands were cramping up and having ringing in the ears.  I recommended him to go to the ER now, he said he had called his PCP and was told the same thing.  He stated he is single and lives alone and does not drive.  I told him to call 911 and he verbalized he is too embarrassed to do that and states he will wait for his daughter to call him.  I offered to call his daughter for him and he declined.   Addendum: Created by RN. 04/16/2021 02:01 PM 04/16/2021 Client called reporting the same symptoms as in 4/13 message -- I told him to go to the ER immediately. He stated he could not drive due to muscle spasms and feet and leg pain. Asked if he would please call 911 and stated that was not necessary. He verbalized he understood my directions and stated he would go to urgent Care. Called Sheriff office to make a well person check.
Complaint of cough, elevated temperature, sore/scratchy throat, runny nose/congestion, myalgia, malaise and diarrhea
Patient developed a large erythematous, indurated area at the site of injection.  The area was oblong and about 13cm on the long axis.  She also developed some nausea and fatigue.
Presented to primary physician on 11/21/2012 with abnormal gait which had been evolving over ~ 10-14 days prior.  Exam and history consistent with Guillain-Barre syndrome, which was agreed upon by the pediatric neurologist who then got involved and continues to follow her.
A non-serious spontaneous report of "child with asthma got H1N1 LAIV was received from a registered nurse/health professional concerning a four-year-old male. The patient's medical history includes wheezing in the past year and a diagnosis of asthma. On 10-Dec-2009, the patient received H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Pfizer vaccine was administered outside - reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------- D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/17/2023 HEMATURIA G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/17/2023 HEMATURIA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/17/2023 GROSS HEMATURIA G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/17/2023 GROSS HEMATURIA
Patient experiencing achiness, weakness, and high fever of 102 leading to delusions starting 12/30/2020. Patient is taking Ibuprofen every 6  hours starting 12/31/2020 and has brought his fever down to 100 currently.
Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  Treatment information was not reported.
MODERNA COVID VACCINE #3 GIVEN 11/8/21, LOT #077C21B; pt residing in SNF, for PT/OT rehab after CVA; DNR/DNI with limited interventions; pt had a positive COVID test on 7/3/22; pt passed away in the SNF on 7/16/22
Approximately 9 hours after receiving the vaccine I developed hives on my forehead and scalp, as well as hives at vaccine site (left arm). I then developed angioedema of my lower lip and tongue the following morning (approximately 16 hours after vaccine), which required me to go to the emergency room. I was given steroids which improved the swelling, will be taking them for 4 days, as well as Benadryl.
Pfizer vaccine x 3. Tested positive for Covid on 02/27/2022. Admitted to Hospital on 02/27/2022. Expired on 03/18/2022 while still hospitalized.
frequent falling to ED via EMS in a c-collar after a fall. Patient states just prior to arrival she got up from the became lightheaded and dizzy and fell down hitting her head - admitted to hospital
Swelling of eyes; Using bathroom alot; Nausea; Breathing problems; Swollen lymph nodes; Meningitis; Dizzy; Pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS (Meningitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Common variable immunodeficiency.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced MENINGITIS (Meningitis) (seriousness criterion medically significant), DIZZINESS (Dizzy) and MYALGIA (Pain all over body). On 03-May-2021, the patient experienced RESPIRATION ABNORMAL (Breathing problems), EYE SWELLING (Swelling of eyes), MICTURITION URGENCY (Using bathroom alot), NAUSEA (Nausea) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, MENINGITIS (Meningitis), RESPIRATION ABNORMAL (Breathing problems), DIZZINESS (Dizzy), EYE SWELLING (Swelling of eyes), MICTURITION URGENCY (Using bathroom alot), NAUSEA (Nausea), MYALGIA (Pain all over body) and LYMPHADENOPATHY (Swollen lymph nodes) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Patient was put on a steroid and also put on a Nebulizer for breathing problems.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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, a causal relationship cannot be excluded.
Pt was vaccinated with Dryvax on 3/12/03. At the end of June 2003, a small fluid filled blister formed in the middle of the original scarring of her left arm. It was associated with some mild pain, but no itching, fever or arm swelling. The blister scabbed over and fell off within a week. She did not seek any medical treatment. Since the time of her original vaccination, pt feels she has been more susceptible to illness and low energy. In June, she experienced a one day vomiting episode. At the beginning of July, she experienced flu like symptoms. At the end of July, she began having recurrent urinary tract infections for which she has been treated with 4 four difference antibiotics (Rocephin, Cipro, Macrobid and Bactrim). These UTI's have resulted in 3 days of time off from work. Her energy has not returned to pre vaccination levels.
UTI; This is a spontaneous report from Pfizer Sponsored Program received from a contactable consumer (patient) reporting for himself. A male patient of an unspecified age received the first dose of BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced UTI (medically significant) on an unspecified date. His neurologist doctor and wanted him to take antibiotics for UTI starting on 10Apr2021 up to 4 days. He is scheduled to receive the second dose on 14Apr2021. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
12 hours post vaccine- severe headache chills chattering teeth fever 100 degrees nausea body ache  right arm pain  24 hours mostly resolved. Residual headache and fatigue.
cellulitis, warmness and redness to site, pain in arm (patient reports not being able to lift arm the next day), flu like symptoms, tiredness
Pt. stated after receiving the 1st dose of the Moderna 06/24/2021, started experiencing a rash developing all over the body 06/26/2021 itchy. Primary communications still awaiting recommendations.
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 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 5 (booster), single (Lot number: Gj5639) at the age of 54 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Noticed a rash the following day. Stated it was hot and burning. Rash noted all over body. Injection site and (L) shoulder swollen, warm, red.
Rash in her face, legs, hands and stomach. Fever and swelling of joints. Treated with Motrin.
Hives on same side of body where H1N1 shot was given. Hives again broke out on Dec 2nd, and continued almost every day for one week.
2/22/14 pt went to ER with swelling in arm (+) pain. 2/28/14 redness not improved, red itchy bumps on torso, chest.
Hospitalization for acute CHF exacerbation and bilateral pleural effusions, elevated troponins, tested covid positive on admission day, 10/24/2023 on dates 10/24/2023- 10/27/2023. Treated with vitamin C 1,000 mg PO daily,  zinc 50 mg PO daily.
Golf ball sized swelling in left deltoid area with extreme heat and redness. Treatment: ice pack, Benadryl, ibuprofen, Tylenol
Fever, chills, joint pain, headache, injection site pain, nausea, fatigue.
A report was received from a health professional on 22Oct02, concerning a female vaccinee who developed upper respiratory symptoms after receiving Fluvirin on an unk date.  On an unk date, the vaccinee received an unknown dose of Fluvirin through a route unk. She developed upper respiratory symptoms and the outcome was reported as unk. The vaccinee has received annual flu vaccinations for 10 years without any adverse reaction.  There was insufficient information to determine the reporters causality assessment. Cross-reference with PJP 2002 00638. Update 1 09Dec02: The vaccinee received the Fluvirin vaccine on 23Oct02. Ref: PJP200200647; PJP200200649.
A 13-year-old female patient with a medical history of neurogenic bladder, reflux and spina bifida, had received an injection of MENACTRA, lot number U2139AA, (expiration date 21 December 2007) on 09 September 2008 and she has experienced fatigue and tiredness since receiving the vaccine.  No other symptoms were reported.  The route/site of vaccination and dose number were not reported.  Laboratory and diagnostic testing was reported as none, and the patient's recovery status was reported as unknown.  No further information was provided at the time of the report.  Documents held by sender:  None