chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 24 year old female patient experienced injection site reaction and acute neurological symptoms after treatment with RabAvert for pre-exposure prophylaxis. The patient received three doses of RabAvert on day 0, 3, and 28 (dates unspecified). Her past medical history and concomitant medications were unspecified. The patient tolerated her first and second dose (day 0 and 3) of RabAvert with minimal injection site reaction of localized tenderness and redness lasting for 2 days following each vaccination. Within 10 minutes after her third vaccination (day 28), the patient complained of numbness and tingling in hands, going up both arms, then down to her knees, along with myalgia and joint pain. No cardiovascular or respiratory symptoms were noted.  The acute neurological symptoms were treated with epinephrine, Benadryl, and Solu-Medrol. Her symptoms progressed and she was unable to lift her legs off the bed. A neurology consult was obtained and resulted in non-specific conclusion. The neurologist noted that the patient's symptom did not follow a specific dermatome distribution. The patient was admitted for overnight observation. Her symptoms resolved by the next morning and she was discharged home.
Arm swelled... Softball sized welt and hot spot on my arm where I got the shot. Saturday 2/27, swelling began in both feet.
Pt s/p TD vaccine 3/1/09, developed fever chills, rigor, malaise, pain @ injection site, admitted to hospital for cellulitis at TD injection site. Treated with Antibiotics.  6/11/09 Received PCP medical records of 3/1-4/12/2009 & hospital d/c summary for 3/2-3/6/2009. FINAL DX: cellulitis injection site left arm Records reveal patient experienced shoulder pain on 3/1 when received vaccine left arm.  Called office 3/2 not feeling well w/chills, rigors, SOB, chest pressure, generalized malaise.  Referred to ER & pt admitted.  Had fever.  Tx w/IV antibioticsCardio & ID consult done.  When seen s/p hospitalization on 4/12 & was improved.  7/13/09 Hospital records received DOS 3/2/09 to 3/6/09. Assessment: arm cellulitis, hypertension, fever, chest tightness. Patient presented with pain in shoulder at deltoid muscle, fever and nonspecific chest tightness, febrile. Mild headache. Left deltoid tenderness, swelling, red. Redness upper lip.  ICD-9 Codes: 038.8, 999.39, 401.9, 272.4, V15.82, E879.8, 786.50
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 3:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 3:10 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 35.11.  Concomitant medication of the patient was not reported.  Batch number 026C21A underwent temperature excursion on 24-May-2021 with temperature of 35 degrees Fahrenheit at 08:00 AM and 09:00 AM. These vials were moved to fridge on 03-May-2021 and 18-May-2021 and beyond use date for the vials was reported as 02-Jun-2021 and 17-Jun-2021. The vaccines moved to clinic on 24-May-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
onset of Tinnitus, temporary loss of hearing in right ear. within 2 hours after vaccine.   regained  hearing within an hour.   on July 26, 2021 at 800 pm sudden hear loss in left ear.  gained hearing back.   tinnitus  continues with no relief.
The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04 JUN 2023 after expiration date 11 MAY 2023 and Dose administered to patient on 5 JUN 2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case was reported for patient 17 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Dose 1 Moderna 2/24/2021 Lot # 002A21A  Pt dies 8/30/2021 of pneumonia, NOT a Covid relate death
21OCT93 site of inject red & swollen; c/o generalized itching, h/a, nervous stomach, referred to MD & advised to call 22OCt93; 10NOV93 pt says seen by MD 22OCT again wk later; had rash on arm & leg, t99; MD felt OK to cont w/Hep B;
Patient experienced  arm pain,  paresthesia, facial flushing, lightheadedness and sensation of dysphagia for several minutes after vaccine was received.  Benadryl PO given when symptoms began. Patient was evaluated in the EC and was discharged home without symptoms.
Pain at injection site starting the evening after first dose - difficulty sleeping on that arm.  No irritation.  Also awoke with chills at 4am on the first night after the injection.  Difficulty sleeping during the night.
mouth and throat were itchy and swollen; mouth and throat were itchy and swollen; mouth and throat were itchy and swollen; Initial information regarding an unsolicited valid non-serious case was received from consumer (patient) via Medical Information (Reference number- 00759668) and transmitted to Sanofi on 08-Sep-2021.  This case involves an unknown age female patient who experienced mouth and throat were itchy and swollen (mouth swelling, pharyngeal swelling and pruritus) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's medical history included COVID-19.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  In 2005, the patient received a dose (once) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Injection) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious mouth and throat were itchy and swollen (mouth swelling, pharyngeal swelling and pruritus) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  It was reported "she went to the emergency room. The doctors told her that she had reacted to something in the vaccine, so she should not get any more flu vaccines, which she has not. But now, she wants a COVID19 vaccine. She states that she had COVID last spring, and she cannot handle having it again. Her physician is telling her that she shouldn't get the vaccine, as she may react to it, as well. She is trying to get a copy of the PI for the flu vaccine that she received, so she and her doctor can compare ingredients with current COVID vaccines."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  On an unknown date, the patient recovered from all the events.  There will be no information available on batch number for this case.
ED to Hosp-Admission Current  - 9/6/2021 - present (9 days) Hospital   Pneumonia due to COVID-19 virus  Assessment/Plan - 88 y.o. female, with past medical history of hypothyroidism, hypertension, rheumatoid arthritis on predisone, DVT, who is admitted on 9/6/2021 with  Pneumonia due to COVID-19 virus   1.  Acute hypoxic respiratory failure due to COVID-19 pneumonia. Per daughter in law, patient only got her first dose of Covid vaccine. She was told not to get the second dose of vaccine due to the correlation between the vaccine and DVT (in April 2021). Her oxygen saturation was 88% on room air.  Patient is put on 4 L nasal cannula oxygen O2 sat 96%. Her D-dimer is elevated 1.54.  Elevated 204.  proCalcitonin is normal 0.18.  CT without contrast shows Multiple foci of ground glass opacification bilaterally. The appearance is consistent with Covid 19.  We will admit patient to telemetry. Start remdesivir for 5 days. Patient is on prednisone 15mg at home for RA. We will hold that and give dexamethasone 6mg daily instead for 10 days. Will trend Ferritin, ALT, CRP. No indication for antibiotics. Will put on Heparin subcutaneous for DVT prophylaxis. It is noted that patient has h/o DVT, but not on anticoagulation due to bleeding (GI, ecchymosis etc). PE can not be ruled out. Since the test won't change the management anyway, we will hold CTA chest for now. Patient's daughter in law in agreement with this plan.    History of left lower extremity DVT, extensive, provoked due to reduced mobility. Patient is not on anticoagulation due to GI bleeding and ecchymosis. Patient declined GI procedure (EGD/colonoscopy). Patient had IVC filter placement on 3/24/2021. Family is aware that even with IVC filter in, there is still risk for pulmonary embolism/DVT.      Acquired hypothyroidism: She is on Synthroid 125 mcg daily (6 times a week from Monday to Saturday).   Essential hypertension:  continue home Lisinopril HCTZ   Rheumatoid arthritis: on steroid as above.    Depression: Mood is relatively stable at this time.  Continue Effexor 25 mg PO BID.   Constipation: Continue MiraLAX and Peri-Colace      o DVT Prophylaxis: Heparin sc    o Disposition:   telemetry o Code Status:  DNR (Do Not Resuscitate)  Patient has a living will with DNR. Confirmed with daughter in law. o Consult Services: none     HPI This is a 88-year-old female with a history of hypertension, rheumatoid arthritis, DVT of the right leg not amenable for anticoagulation due to prior GI bleed who presented to the emergency room with one-week history of increased shortness of breath, cough,  fatigue weakness and found to be with a saturation of 89% on room air.     Patient presents to the emergency room via EMS that placed patient on 4 L.  Patient has only been vaccinated for 1st dose of Covid.  Denies any fever chills denies any chest pain. Patient is a poor historian.   Her Covid is positive. She has IVC filter. CT chest without contrast shows bilateral Multiple foci of ground glass opacification. Consistent with Covid -19.
2  hours after receiving injection started hives. Spread over body and worse on scalp. Some fullness in throat. Took BENADRYL - seen at clinic 20 hours later. Symptoms resolved.
A few hours after the first dose of the Pfizer shot, I started to have the same reaction (puffy eyes, nose and lips) as I do when I consume dairy (I did not have any dairy products this day). Immediately after, I had terrible abdominal pain and diarrhea. I had bloody stool and still continue to have bloody stools until today (3 days after the first dose).
injection site (arm) has a spot about 3 inches and there is also a 1 x 2 inch patch; The rash on her face was more like on the side of her neck; bunch of little hives around the injection site, almost like where it spread; she can feel heat; It is sometimes itchy; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 32 years old female patient who experienced injection site (arm) has a spot about 3 inches and there is also a 1 x 2 inch patch (vaccination site reaction), rash on her face was more like on the side of her neck (rash), bunch of little hives around the injection site, almost like where it spread (urticaria), she can feel heat (vaccination site warmth) and it is sometimes itchy (vaccination site pruritus), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included INFLUENZA VACCINE.  Medical history, medical treatment(s) and family history were not provided.   On 09-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ279AA and expiry date: 06-Jun-2019) via unknown route in the right arm.  On an unknown date, the patient experienced a non-serious injection site (arm) has a spot about 3 inches and there is also a 1 x 2 inch patch (vaccination site reaction) (Unknown latency), following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that, another wheal that is raised. There was also a 1 x 2 inch patch and under that, an inch circle on her arm. Her face was red. The mom of the patient told the pharmacist that the reaction was a little better than at first. It still seems to have heat in it. It was reported that, the rash on her face was more like on the side of her neck and is gone now(rash). The rash on her arm is still there but not getting bigger. It is sometimes itchy (vaccination site pruritus) and she can feel heat (vaccination site warmth). It was reported that, it looks like a bunch of little hives around the injection site, almost like where it spread (urticaria).  No laboratory data reported.  Final diagnosis was vaccination site pruritus, vaccination site warmth, rash, urticarial and vaccination site reaction.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient outcome were reported as recovering for vaccination site reaction and rash.  The patient outcome were reported as unknown for urticarial, vaccination site warmth and vaccination site pruritus.
FEVER; FAST HEART RATE; DIFFICULTY SLEEPING; HOT FLASHES; FEELS CRUDDY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubal ligation, high fever, and hospitalization, and concurrent conditions included high blood pressure, hypothyroidism, strawberry allergy, random medication allergy, non-smoker, and non alcoholic, and other pre-existing medical conditions included dtap vaccination while pregnant and had reaction or virus at same time in 2018. 3 children, with 1 daughter born with 1/2 of her heart. no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:45 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) 100-105 {beats}/min. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced difficulty sleeping. On 07-APR-2021, the subject experienced hot flashes. On 07-APR-2021, the subject experienced feels cruddy. On 07-APR-2021 19:00, the subject experienced fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) 3-4 times negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate, hot flashes, and fever on 08-APR-2021, and difficulty sleeping on 09-APR-2021, and was recovering from feels cruddy. This report was non-serious. This case, from the same reporter is linked to 20210420086.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Dose Number: 3; Arm pain; fatigure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Dose Number: 3"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovering", described as "Arm pain"; FATIGUE (non-serious) with onset Nov2021, outcome "recovering", described as "fatigure". It was unknown if therapeutic measures were taken as a result of pain in extremity, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown prior to vaccination, if the patient diagnosed with COVID-19 and has been tested for COVID-19 since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
48 hours post vax the pt broke out in a rash all over her body. The pt was treated with Benadryl. The most recent information received reports the outcome of the event as resolved.
lost my sense of smell and taste; lost my sense of smell and taste for 20 minutes; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 21Mar2021 at 15:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive concomitant medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 20:30, about 5 hours after the vaccination, the patient lost her smell and taste for 20 minutes ("luckily it didn't last"). The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events lost her smell and taste for 20 minutes. The clinical outcomes of the events lost her smell and taste for 20 minutes were recovered on 21Mar2021 at 20.50.  No follow-up attempts are needed. No further information is expected.
Flu; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case received from a patient via social media.  This case involves a patient of unknown age and gender  who developed flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, I got the flu shot and I got the Flu but it would have been worse without the shot!  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
within 3 days of vaccination developed lacy erythema near the vaccination site (just distal to it). No systemic illness. The rash resolved within a few days.
S/SX: erythema, mild inflammation of (L) thigh (8 x 7 cm) noted one day after injection provided. TX: cool compress, antihistamine, hydrocortisone cream prn.
90 y/o male patient hospitalized in Sept 2009 for left shoulder/pain after vaccination with PNEUMOVAX 23. Case referred.