chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever/ chills/ muscle ache/ nausea/ injection site pain, 3 day duration.   Toughed it out at home.   Symptoms resolved.
I started having pain in one side of my body; I find out I had a shingle that is it and very painful; This is a spontaneous report from a contactable consumer or other non-health professional (patient) reported for herself.   A female patient of an unspecified age received dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose and received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  She had adverse side effect from the Pfizer, she got the first dose and second dose and may be two weeks later or more may be after two week, she started had pain in one side of body for about a week and then later she found out had a shingle that is it and very painful. She wanted to know about any information about shingles as an adverse event to the Pfizer COVID-19 vaccine. She don't feel comfortable.She said that she had shingles after receiving the vaccine. The outcome of the events was resolving.  Information on the lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.  Follow-up (11Jun2021): This is a Follow-up spontaneous report from a contactable consumer (patient) reported for herself.   Information on the lot/batch number has been requested.
Vaccine administered (according to chart documentation) is 5-11 year old Pfizer monovalent dose. The patient is 2 years old and should have received the 6 mo-4 yr Pfizer bivalent dose.
rash around the injection site/a rash a little below the injection site; arm started to itch; looked like hives; red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red). At the time of the report, INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red). At the time of the report, INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Shortness of breath, which we thought was my asthma saw my Allergist  treated for Sinus infection, Biaxin and Prednisone, changed inhlaer to stronger did not help 25 March. Added more Predisone 60 50 40 30 20 10  x2 for each, really short of breath, Chest xray 8 April , Pulmonary Vascular congestion, and mild interstitial edema treated with Lasix 40 mg for 3 days then down to 20 mg, and off of it. Off now since Sunday and continue to have shortness of breath. I also have a rash on my chest.
heart changes; left ventricular remodeling with fibrosis of the left ventricle; left ventricular remodeling with fibrosis of the left ventricle; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (batch/lot number: GJ3274) at the age of 60 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "type II diabetes" (unspecified if ongoing); "emphysema" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM; EDARBI; FARXIGA; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Oxycodone, reaction: "drug allergy". Vaccination history included: Bnt162b2 (dose 1, batch/lot number EP6955, anatomical location arm left), for COVID-19 immunization; Bnt162b2 (dose 2, batch/lot number ER8729, anatomical location arm left), for COVID-19 immunization; Bnt162b2 (dose 3, batch/lot number 301358A, anatomical location arm left), for COVID-19 immunization. The following information was reported: VENTRICULAR REMODELLING (disability), MYOCARDIAL FIBROSIS (disability) all with onset Aug2022, outcome "recovered with sequelae" and all described as "left ventricular remodeling with fibrosis of the left ventricle"; CARDIAC DISORDER (disability) with onset Oct2023, outcome "unknown", described as "heart changes". The events "left ventricular remodeling with fibrosis of the left ventricle" and "heart changes" required physician office visit. The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) unremarkable, notes: with any stenosis seen under 25%; echocardiogram: (Oct2023) heart changes; EKG: (Aug2021) normal; (Aug2022) unknown results; (Aug2022) left ventricular remodeling, notes: with fibrosis of the left ventricle; nasal swab (covid-19 test): (Jun2023) negative. Therapeutic measures were not taken as a result of ventricular remodelling, myocardial fibrosis, cardiac disorder.  Clinical course: The patient had no covid prior vaccination. The vaccination facility type was pharmacy/drug store. The left ventricular remodeling with fibrosis of the left ventricle, first detected by EKG changes in Aug2022, confirmed in Aug2023. The patient recovered with lasting effects.
Fevers for 3 full days following seconddose; Body aches; Loss of appetite; This is a spontaneous report from a contactable pharmacist, the patient. A 29-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in right arm, on 29Jan2021 at 16:45 (at the age of 29 years) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications were not provided. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in left arm on 08Jan2021 at 16:45 (at the age of 29 years) as a single dose for COVID-19 Immunisation. On 29Jan2021 at 23:00 hours the patient experienced fevers for 3 full days following second dose, body aches and loss of appetite. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures, which included nasal swab COVID-19 virus test on 10Mar2021 and tested negative. No therapeutic measures were taken for the events. The clinical outcome for the events fever, body aches and loss of appetite was recovered on unknown date in 2021.   Information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions, drug reactions or allergies was provided. On 12-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneous injection, lot # M030138, expiration date 15-JUN-2018 (dose was not reported). The vaccine was stored improperly for 47,5 hours  in the temperature between 14 and 46 degrees Fahrenheit.. The temperature excursion was registered by the digital data logger. No adverse events were reported. This is one of the several reports received from by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA014145:
40 patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported It was reported that only lot number: 059H21A was affected and it was first thawed on 28-Jan-2022 It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. No Treatments were reported.   This case was linked to MOD-2022-540883 (Patient Link).
Information has been received from a consumer concerning his 69 year old wife with arthritis who on 02-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). On 31-MAY-2010 the patient experienced a case of shingles. The patient received unspecified medical attention. The patient's shingles persisted. Additional information has been requested.
headache; dizziness; heaviness; ringing in the ears; numbness; black spots; This is spontaneous report from contactable consumer (patient, self-reported). A 19-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8734 and expiration date was not reported), via unspecified route of administration in right arm on 05Apr2021 at 14:15 (at 19-years age) 1ST dose single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had received the other vaccine (not specified) same date 5Apr2021, 2 ND dose, batch no: EW0170, in Left arm. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Apr2021 at 12:15 the patient had experienced headache, dizziness, heaviness, ringing in the ears, black spots and body numbness. The patient had underwent the lab COVID-19 test negative (nasal swab). The patient did not received any treatment for the adverse events. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (PRD 28Apr2021): This is a follow up-spontaneous report from a contactable consumer, added the suspect drug details, added the events, added the lab data.
Received vaccine on 7/18/17 on 7/20/17 noticed a chicken pox to leg vaccine given in. Fever started on 7/25/17 and noted large red area to left leg, decreased appetite, seen in urgent care DX with viral illness.
had difficulty driving; Severe chills; fever; body ache; diarrhea; fatigue; Felt worse than the 2nd shot and much worse than first shot.; dizziness; Booster; This is a spontaneous report from a non-contactable consumer (Patient). A 41-years-old male patient received third dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: 330268D), dose 3 via an unspecified route, administered in Arm Left on 04Nov2021 11:15 (at the age of 41 years old) as dose 3 (booster), single for covid-19 immunisation. Medical history included Known allergies: Tree fruits and nuts. There were no concomitant medications reported. Historical vaccination included first dose of BNT162B2 (solution for injection, Batch/Lot Number: CP7534) via an unspecified route, administered in Arm Left on 17Mar2021 at 18:00 and second dose of BNT162B2 (solution for injection, Batch/Lot Number: EW0153) via an unspecified route, administered in Arm Left on 07-APR-2021 at 15:00 for covid-19 immunization. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 04Nov2021 at 11:15 the patient experienced booster. On 05Nov2021 at 14:00 the patient experienced, had difficulty driving, severe chills, fever, body ache, diarrhoea, fatigue, felt worse than the 2nd shot and much worse than first shot and dizziness. The patient reported the events as Severe chills, fever, body ache, diarrhea and fatigue from 14: 00 on day 2 which was 27 hrs after the booster shot. Felt worse than the 2nd shot and much worse than first shot. Booster shot caused dizziness and had difficulty driving. Reaction was delayed and hit suddenly. No treatment received for the events. The outcome of the events had difficulty driving, severe chills, fever, body ache, diarrhea, fatigue, felt worse than the 2nd shot and much worse than first shot and dizziness was resolving. No follow-up attempts are possible. No further information is expected.
I experienced my heart racing  as I was driving back to my clinic. This happened about 45 minutes after getting the vaccine. Twice while I drove back to work and twice while I was working. These episodes were brief. I also experienced numbness and tingling in my arm that received the injection. This feeling spread to my shoulder and traveled up my neck to my face. I had numbness and tingling on my left side of my face and lower lip. This lasted  till about 3:30 pm and then went away.  Tonight around 7:00 pm I am still experiencing some numbness and tingling on my face and lip which comes and goes. I am having soreness in my arm at the injection site.
Got a red circle of 5 cm; This spontaneous case, initially received on 05-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported.  On 03-Oct-2018, the patient was administered Afluria Quadrivalent [influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 00344611A (reported as 03144611A) and expiry date: 30-Jun-2019] for active immunization against influenza.   On 04-Oct-2018, 1 day after vaccination, the patient developed a red circle of 5 cm. On 05-Oct-2018, red circle reduced to 4 cm. The patient's treatment medications were not reported.  It was reported that, the patient was not hospitalized.  At the time of this report, the patient had not yet recovered from the event.  The reporter assessed this case as non-serious.  This case 201804329 was cross-linked to the case 201804327 due to the same reporter.; Reporter's Comments: A female patient of unspecified age developed redness, 1 day after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related due to plausible temporal relationship between the event and suspect vaccine.
Fever /Chills/Back ache/joint ache/cough/hot flashes/headache/
pt recv vax 31JUL95 & 14JUL97 pt to MD w/herpes zoster consisting of a rash on rt hip & around rt thigh & buttock;also exp a fever;lab eval by PCR revealed vax strain of VZV;
(L) arm reddened after 24 hr. Pt saw MD 5/8/08 and was instructed to put a cold pack to area. Mother of pt states he has a latex allergy-no reaction in (R) arm where Tdap was given on the same day.
Are too sore to move right after shot.  24 hours later small white dots, red rash with itching under chin, cheeks, started covering entire face and neck.  The location of the shots is red, firm, hot, swollen from shoulder to elbow.
Severe shoulder pain.  Unable to sleep.  Developed over the course of the afternoon and it was 9/10 in severity by evening/bedtime.
Severe headache 2 days in duration with associated nausea and vomiting, admitted with hypertensive urgency, Cerebral Venous Sinus Thrombosis diagnosed via MRV and CTA
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 17-DEC-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported an no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Bruising on left arm, hard lymphnodes at injection sites, swelling, redness, tenderness, itchy, noticed on 02/10 7 PM after shower
gums were enlarged/gum discomfort; teeth did not fit in them; left eye and her vision were tired; lightheaded; pressure on her entire head; redness; burning sensation on the face and gums/burning sensation on the left side of her face; hypertense; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration on 13Mar2021 (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded fifteen minutes after vaccination on 13Mar2021, on the same day after 20-25 minutes she felt pressure on her entire head, redness and burning sensation on the face and gums, where she was hypertense. The patient also felt her gums were enlarged and felt the teeth did not fit in them, for 15-20 minutes she had a burning sensation on the left side of her face and had gum discomfort, she felt her left eye and her vision were tired. The patient received treatment for hypertense. The treatment medication was chlordiazepoxide. The outcome of lightheaded was resolved on 13Mar2021. The outcome of pressure on her entire head was resolved on an unspecified date in Mar2021 and for all the other events was resolving.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
Pt said after receiving vaccine she  noticed that the left side of her  face and both feet feel numb. She has not contacted her primary care yet.
The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) in a 52-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 26-Feb-2022 at 11:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Feb-2022 at 11:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had received the vaccine dose number as booster.  No Concomitant medication reported.  The patient had any race.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed.  No Treatment medication was reported.
The volume of the ringing from my tinnitus has gotten much louder. Started pretty much right after the injection. Was hoping it would go down. But has not.