chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm 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) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 14Sep2022 to 18Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vomiting on 8SEP92 @ 1AM h/a & fever (temp not measured) on 8SEp92 during the day; feeling better on 9SEP92; rash onset on 10SEP92 in AM generalized;
Edema and erythema with indurated area covering most of anterior thigh (left thigh).
dry mouth; over salivation; burning syndrome in her mouth and reactions in her mouth; has problems with her teeth; can not wear her nightguard at night because it is too irritating; frustrating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 12:45 (Lot number: ER8731) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; SIMVASTATIN; CLONAZEPAM; SYNTHROID. Vaccination history included: Bnt162b2 (1st dose, LOT#(1st dose): Consumer stated, "ER8734.", Mailing address and telephone#: Consumer stated, "My first vaccination was also at 12:45 PM, (name-withheld) the address is (address-withheld), (telephone number-withheld)."), administration date: 12Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious) with onset 03May2021, outcome "unknown", described as "dry mouth"; SALIVARY HYPERSECRETION (non-serious) with onset 03May2021, outcome "unknown", described as "over salivation"; BURNING SENSATION (non-serious) with onset 03May2021, outcome "unknown", described as "burning syndrome in her mouth and reactions in her mouth"; TOOTH DISORDER (non-serious) with onset 03May2021, outcome "unknown", described as "has problems with her teeth"; DENTAL DISCOMFORT (non-serious) with onset 03May2021, outcome "unknown", described as "can not wear her nightguard at night because it is too irritating"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 03May2021, outcome "unknown", described as "frustrating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dry mouth, salivary hypersecretion, burning sensation, tooth disorder, dental discomfort, frustration tolerance decreased. No follow-up attempts are possible. No further information is expected.
Cellulitis of left thigh 2 days after vaccines. Seen at ER, then follow-up with me. Responding well to antibiotics.
Rubella rash - maculopapular, fine, to chest, back, face & upper extremities no fever, chills, arthralgias
I had eye irritation. I had itchy eyes that lasted for about 2 weeks. I went to the doctors about this.
syncope, c/o itchy throat Narrative: Patient was seen prior to administration of the Moderna COVID-19 vaccination. He has allergies to bees/egg and a h/o anaphylaxis 2/2 receiving an injection of penicillin in the past. Discussed that prior h/o anaphylaxis to PCN injection was not a contraindication to this vaccination, but is a precaution. Discussed risks of receiving the vaccination vs benefits of the vaccine, which patient states "I already had this discussion with Dr.!" He has multiple comorbidities which place him at a higher risk for more severe illness from COVID-19. Again received the risk vs benefit discussion. Patient stated understanding and desire to proceed with the vaccination. He will be monitored for at least 30 minutes in area where staff can directly observe him. Patient received the COVID vaccination at 13:00. At 45 minutes later, staff alerted that he was c/o palpitations. Due to confusion and weakness, we were unable to transport him to an examination room. Oxygen, water, and vitals machine were brought to him. He presented with SOB, confusion, lightheadedness. Exam demonstrated acute distress, speaking in staccato sentences. HR in 80s, with lungs CTAB and no stridor - despite increased RR to 20s. Vitals with HR in 70s, SpO2 remained 97% or greater on RA. BP was initially 140/72. A code blue was called and Drs. presented to the area. Patient c/o itchy throat and still p/w confusion/combativeness, loss of orientation, and SOB. No visible swelling noticed. At around 13:58, patient syncopized. HR and SpO2 remained 70-80s and >98% on room air respectively. Pulse remained palpable. At that time, an epipen was administered. Patient woke up. During the entire episode, he was able to recognize a staff member with whom he was previously familiar. EMS arrived, vitals remained stable. EMS transported patient to the ER for further monitoring and f/u. Concern for immediate allergic reaction 2/2 vaccination. After event, patient in need of referral to allergy provider for evaluation prior to consideration of 2nd dosage.
She has not yet received her second Shingrix dose; developed shingles in eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In August 2022, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR140062   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine on unknown arm. The reporter stated that the patient experienced Shingles in her eye in early august 2022. The reporter stated that last week the patient started Valacyclovir for 10 days to treat the shingles. The patient had not received her second dose of Shingrix Yet. The reporter nothing had else to report. The reporter declined to provide contact information and demographics. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2022AMR140062 reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR140062:same reproter, same patient
Arm was swollen in a 3" diameter raised about 1/2 inch by 4:00 in the afternoon even though I had taken ibuprofen at 11:00. By 5:30 I was achy all over and had the chills.  The tightness in my throat which had finally gone away, came back with a vengeance and my chest was tight and my lungs were achy as well. I took ibuprofen at 6:00, Tylenol at 10:00, ibuprofen at 3:00 am, and Tylenol at 7:30 am, and ibuprofen at 11:00 am this got me through work on Friday. I decided not to take anymore drugs because I had taken a lot. By 6:00 my throat was really tight and my lungs hurt, as well I had the chills again. So I took Tylenol at 6:00, Ibuprofen at 8:30, and Tylenol at midnight, and ibuprofen at 7:30 am. That was the last time I took medication. The chills did not come back, but the tightness in my throat did once the medication wore off.
Pt received Immunization on 4/22/09.  Onset of symptoms on 4/23/09.  Nausea, headache, Stiff neck, arm weakness, flushing, dizziness, lethargic, feelings of discrientation.
Nausea and extreme diarrhea to the point of blood in the stool starting 16 hours after getting the vaccine and continued through the day.
Itchy Rash all over body; Very Tired; Body Aches; clammy hot and cold; headache; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced itchy rash all over body. On MAR-2021, the subject experienced very tired. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced clammy hot and cold. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash all over body, very tired, body aches, clammy hot and cold, and headache. This report was non-serious.
epistaxis and decreased plt count    of note, it was his second dose of Pfizer vaccine last Wed 4/14/21 with CBC done Friday 4/16 showing plts down to 53 from 87 when last checked in December and 101 in June of 2020. remainder of CBC WNL
Pt called to report that L delt area was red, large knot, hot to touch and became itchy, by PM after vaccine.
This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided. On 06-MAY-2022, the patient was vaccinated with a dose of an expired Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis, lot number #U003464 and expiration date 02-MAY-2022 (strength, dose, frequency and route of administration were not reported).   No adverse events were reported.  This is one of 2 reports received from the same reporter (MARRS #US-009507513-2205USA003680) ; Sender's Comments:  US-009507513-2205USA003680:Case Number: 02164360
FATIGUE, NAUSEA, AND PAIN AT THE INJECTION SITE. Missed work d/t symptoms.
Fever (not taken by parent)-mild began 6AUG91, redness 6cm x 4cm  @ DTP site, blister 1cm @ HIB site; Restless last night; Good appetite today; Alert & smiling;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Solitary Fibrous Tumor (Benign)" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE; OMEPRAZOLE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: Antiviral treatment for COVID 19 were started from 01May2022 to 05May2022. Adverse event: Likely recrudescence two days after stoping Paxlovid. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event: Likely recrudescence two days after stopped Paxlovid. Device Date on 18May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Dad noticed a raised area on  patients left thigh yesterday. Since yesterday raised area has increased in diameter. Area is hard to touch.
arm pain, generalized muscle pain, nausea, vomiting, upset stomach, headache, fatigue, light sensitivity, fever, chills
On 10/12 at 9 pm, presented to IC nurse who gave immunization. Rash over entire body, sent to Clinic, was put on Benadryl. States woke up with rash in morning, also had pied for sipper the night before? of reaction from olsu. Rash gone in a few days.
Arthralgia, Fever, ErythemaMultiform, Chills, malaise,knee/ankle/wrist joint pain, fatigue, itchingm , welts vaccine injection Narrative:
09/20/2006 rubella vaccine given, 9/26/06 mother reports she was not herself, 9/27/06 some cough and clear rhinorrhea, 6am nostrial given, 1pm 98.9 but felt warmer, tired, not herself. Nanny went to put her in for nap she began to shake in shoulder, she was unresponsive then flaccid taken to ER via 911, woke up in ER found to be 1016 in ER. ER MD reported some Left otitis but not bulging.
muscle spasms, ankles, calf, neck, lasts 30sec to 1 minute, daily
Generalized body aches, fever, chills with erythema, edema and warmth at injection site within 24 hours of injection.
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist 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: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced incorrect product storage. On 19-OCT-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Information has been received from a pharmacist concerning her 20 year old daughter with a latex allergy, acne and no pertinent medical history who in the middle of MAY 2007 was vaccinated with a first dose of Gardasil (lot # unknown). Concomitant therapy included acne medication (unspecified) and spironolactone. On 24-JUL-2007 the patient was vaccinated with a second dose of Gardasil and collapsed. Her daughter stated that it hurt going in. Approximately 7 to 10 minutes after the injection and while making an appointment, the patient blacked out. The patient stated to her mother that she felt woozy all night. Medical attention was sought. On 25-JUL-2007 the next day the patient had recovered. Additional information has been requested.
Information has been received from a registered nurse concerning a 13 year old male patient who on 21-MAY-2010 was vaccinated with a second dose of VARIVAX (Merck) (lot number 665971/1563Y) after antiviral therapy. Concomitant vaccination included a dose of meningococcal vaccine (unspecified). The nurse reported that on 22-MAY-2010 at 22:00 the patient developed headache and was given MOTRIN. At 23:00 the patient developed drooling of saliva and mouth dropping. The patient was taken to the emergency room and was diagnosed with Bell's palsy. The patient was treated with VALTREX and prednisolone but was not admitted to the hospital. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Pt received ZOSTAVAX on 11/16/11, called on 11/22/11 to report a nosebleed. Pt said she did not change her routine other than receiving this vaccine. She is not sure whether this is related to the vaccine or not. She has not contacted her PCP regarding this.
Pain in left deltoid muscle when extending arm in most directions since she received the vaccination on 9/5/2017. Going to see nurse practitioner tomorrow for regular check up and to evaluate her left deltoid muscle.
I have very itchy hands, arms, feet, legs and face and scalp. I can?t get it to stop at all. I?ve taken allergy medicine but it only helps a little.
I have cellulitis The emergency room doctor said It was due to the medication at that injection site. I am now on antibiotic's for the next seven days also they gave me a shot in the ER of the antibiotic.
DIARRHEA; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and sore arm on 11-APR-2021, and had not recovered from headache. This report was non-serious.
Both eyes blurry and foggy, H/A, Chills, Stomach ache, all has resided but currently still weak.
Atopic dermatitis to face and neck; This case was reported by a consumer and described the occurrence of atopic dermatitis in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included desloratadine (Clarinex).   In October 2022, the patient received the 1st dose of Shingrix. On 31st October 2022, less than a month after receiving Shingrix, the patient experienced atopic dermatitis. The patient was treated with antihistamine, tacrolimus and dexamethasone (Dexamethasone Cream). On an unknown date, the outcome of the atopic dermatitis was not recovered/not resolved.   It was unknown if the reporter considered the atopic dermatitis to be related to Shingrix.     Additional Information: GSK Receipt date: 30-Dec-2022. Reporter's Comment: The patient self-reported this case. The patient saw a dermatologist and now and allergist. Treating with antihistamine and tacrolimus after treating with dexamethasone cream and antihistamines. Had blood work done for allergies and eosinophils and had skin tests done for allergies. The symptoms were treated.
Given first GARDASIL vaccine, reported dizziness about 5 minutes after vaccine was given. After 15 minutes the patient had fainting episode while lying on exam table. Blood pressure was normal. Glucose was 81. Urgent care was contact. Patient was transported down stairs to urgent care for further evaluation.
This was a duplicate flu shot. Patient had already received a first flu shot in October, but insurance let it go through and we were so busy no one noticed. No adverse events came from it.
Noted increased sleep after DTP #3 on 30JUL90. Sleeping 20 hrs a day. Lasted over 1 month.
Severe headache lasting 36 hours,  chills,  sweating, swollen glands (still swollen 15 days later),  nausea
Within 3 hours I was achy, headache, very very dizzy (room spinning around, sick on my stomach and cold sweats for about 48 hours. Arm swollen and extremely sore. No fever, no lose of taste or smell.
fever, lost of balance, vomiting, headache, arching his back,  baby stopped saying words he used to say fora 1 week after vaccine was given, no reaction or interaction on outside world for a week.
This spontaneous report was received from a Nurse and refers to improperly stored products which had not been administered. On unknown dates, vaccines of VARIVAX (which had a lot # K015970, expiry date on 23-SEP-2016, exact doses and route of administration were not reported), were improperly stored as the freezer was out of range on an off since 06-JUN-2016. Other doses of VARIVAX which had lot # L028275 with expiration date on 28_JUL-2016, Lot # L038132 expiration date on 01-OCT-2017, Lot # L029466 expiration date on 06-AUG-2017. Nevertheless, no symptoms were reported. The vaccines experienced the following temperature excursion during 48 hours (2 days): 10 grades Fahrenheit. Reportedly, there had been previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same source. Additional information had been requested.
No adverse event; Inadvertently administered the bivalent booster dose at 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Inadvertently administered the bivalent booster dose at 0.25 ml) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 30-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Inadvertently administered the bivalent booster dose at 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Inadvertently administered the bivalent booster dose at 0.25 ml) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Inadvertently administered the bivalent booster dose at 0.25 ml).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter. This report was for the 2nd patient.   This case was linked to MODERNATX, INC.-MOD-2022-655893 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-655893: Crosslink case with same reporter
Patient called the morning after receiving the PNEUMOVAX 23 vaccine and complained of her entire upper right arm being swollen, painful and warm to touch. I advised her to ice the area and take ibuprofen for relief of pain and swelling. I also advised her to call the doctor if it does not improve within the week.
Developed redness of left deltoid area of upper arm immediately after vaccines just mild next day more redness. Took MOTRIN a topical BENADRYL for itching. No hives.