chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woman on the phone told me to fill out a report because of the symptoms i was having.   I had what appeared to be a chest cold.  My doctor prescribes ZPACK due to me be Fully Vaccinated and i had a negative antigen and PCR test for covid 19.   After taking all prescribed medication, i then tested POSITVE on an antigen test and then Positive on a PCR test, a full week later.  Symptoms now have subsided, however i tested positive on an antigen test again today 1/7/22
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with the doses of improperly stored GARDASIL lot # J011272, expiration date 21-APR-2016, lot # K006124, expiration date 02-FEB-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
09/05/2002 Noted rash yesterday right arm. Today spreading upward from deltoid toward shoulder with some itching, hot to touch. 9/6/02 Mom gave Benadryl; rash clearing almost gone. Arm (right deltoid) warm to touch; using cool compresses, much better.
On 5/14/18 in the evening of the injection, the patient started to experience dizziness, chills, fever, redness at the site along with swelling and warmth at the site
Developed arthritis symptoms with swollen knuckles in right hand, hard to open jars etc.   Also breast tenderness couple weeks after second dose and still tender.
Very tired that afternoon later that night Chills, low fever, aches, nauseous ,headache ongoing   Noticed burning spot on face above right eye Saturday 5-1-2021  then it spread to bigger area  forehead and top of head  it is a   blistery burning rash , welts on face and head. Still ongoing 5/2/2021
Estimated delivery date 047/01/2021  About 15 min after the vax, injection site was hot to the touch, very sore and red. Next day it was worse, larger area. Called PCP next day and was checked and they were not too concerned since I had no other symptoms. I could not even sleep on my left side due to the pain and soreness. It slowly started getting better after 4 days but it still has  big red bump on my shoulder until now.  Does not hurt now but it is itchy.
Approximately 3 days post vax, pt experienced sneezing, nasal congestion and watery eyes.  Within 7 days post vax, pt experienced sinusitis and a head cold. The reporter believes that there was no association between the pt's symptoms and the hepatitis A vaccine. The reporter noted in follow-up that the pt recovered from symptoms. No further details were provided.
Arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 14Jan2021 14:50 (Lot number: EL8982) at the age of 87 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was a little sore". Additional information: Patient did not received any other vaccination within 4 weeks prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045522 same reporter and drug, similar event, different patient
fever, chills, malaise, n/v started 2-3hr p/vax 5MAY99 reported to office 8AM 6MAY99;
1 week after flu shot, patient states leg pain unlike any she has had before, which started as once a week, but has increased to be more frequent.
The patient received first dose on 23Apr2021 and second dose on 05May2021; Shingles outbreak across upper torso; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 05May2021 at 14:15 (at the age 35-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 23Apr2021 (at the age 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021, one week after second shot, the patient experienced shingles outbreak across upper torso. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported event which included medication as prescribed by doctor. The clinical outcome of shingles outbreak across upper torso was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I got a fever of 101.8. I got a lymph's node- was a size of a soft ball- behind my left ear, left armpit, left side of my groin. Headache 5mins after I got the shot, and this that lasted 3days right after the vaccination I got a tingling the very top my head down my face.
Pt was in observation, after receiving Moderna 0.5mL IM, c/o difficulty breathing through Lt. nostril and itching to neck area. Upon assessment noted redness and swelling to neck area, no flaring of nares noted. Administered Benadrly 0.5ml IM to Lt deltoid, tolerated well. 21:00-no redness or swelling noted, no complaint of difficulty breathing voiced.
Case completed Covid vaccine series 4/11/21 then was hospitalized for Covid 6 months later.   Acute respiratory failure due to COVID-19  Assessment & Plan Acute respiratory failure secondary to COVID-19 infection, pneumonia. Patient with hypoxia admission requiring up to 2 L to maintain oxygen saturation above 90%. Patient with underlying COPD but no oxygen dependency at home. We will continue with oxygen for support to maintain oxygen saturation 88 to 92% in the setting of COPD. RT to evaluate and treat as needed. Treat underlying COVID-19 pneumonia.  Pneumonia due to COVID-19 virus Assessment & Plan Patient with 5-day history of mild upper respiratory congestion and one-time episode of hemoptysis on the day of admission which prompted her visit to the emergency room. Medical history includes both cardiac and pulmonary disease. Patient not on any oxygen at home and in emergency required up to 2 L of oxygen to maintain oxygen saturation above 90%. Found to be COVID-19 positive. CTA done and negative for pulmonary embolism but consistent with inflammatory or infectious pneumonia.   Patient initiated remdesivir for 5 days to complete therapy 10/28/2021 or sooner on the day of discharge. Initiate dexamethasone 6 mg p.o. daily. CMP daily while on remdesivir. Oxygen for support with goal of oxygen saturation between 88 and 92% in setting of COPD.   Patient recently on prednisone taper at home and per her report taking 20 mg of prednisone daily. Did not alter dexamethasone dosing.   Told patient not to continue prednisone on discharge and take dexamethasone instead.
ITP; This is a spontaneous report from a contactable physician. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 14May2021 (batch/lot number was not reported), as unknown, single dose, at age 33 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included systemic lupus erythematosus (reported as "h/o SLE0") from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. On 18May2021, the patient experienced ITP (immune thrombocytopenia). The event required hospitalization on an unspecified date with duration 4 days. Treatment included Decadron 40 mg IV x 4 days. On 21May2021, the patient underwent COVID-19 nasal swab with result: negative. The patient recovered from the event on an unspecified date.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Moderna COVID 19 Vaccine EUA Next day 12/23 after 5pm  Chills, Temp 100.9. 12/24  Temp Current 99
Occipital headache, denies vision changes  Epidural hematoma Non-STEMI elevated troponin Rigors
Mild fever 24 hours or so after shot. 48 hours or so after shot injection site on arm became red and inflamed and itchy.
Had a mild case of COVID; Had a mild case of COVID; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team and product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), on 12Jan2021 as dose 2, single (Lot number: EL1284) and on 26Sep2021 as dose 3 (booster), single (Lot number: FF2888) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Had surgery in the left arm" (unspecified if ongoing), notes: Had surgery in the left arm; "Chronic back issues" (unspecified if ongoing), notes: Chronic back issues; "Back pain and sleep" (unspecified if ongoing), notes: back pain and sleep; "Back pain and sleep" (unspecified if ongoing), notes: back pain and sleep; "Allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: LORTAB [LORATADINE] taken for back pain, insomnia, musculoskeletal discomfort; FINASTERIDE; FLUTICASONE taken for rhinitis allergic; VITAMIN D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN] oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had a mild case of COVID". The patient underwent the following laboratory tests and procedures: Full blood count: ok, notes: All blood counts and chemistry counts have been ok; Haemoglobin: very slight low hemoglobin but not much, notes: Had very slight low hemoglobin but not much; Chemistry count: chemistry counts have been ok, notes: All blood counts and chemistry counts have been ok.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
lt deltoid red, swollen in 4" area circumference;c/o pain mom giving APAP lt ax was swollen;sx started day p/vax again;
A report was received from a health care professional on 2/24/04 concerning up to 8 vaccinees under 4 years of age and of unknown gender who inadvertently received a dose of Fluvirin vaccine on an unreported day in December 2003. On an unspecified day in December 2003, up to 8 vaccinees were inadvertently administered Fluvirin. The outcome of the event was not reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Further information was received from a health care professional indicating that the vaccinee was a 45 month old female who inadvertently received 0.5ml Fluvirin on 1/12/04. No adverse events were reported at the time of the event. No follow up pending. All information received.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2022, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient had been administered with the Moderna vaccine which were beyond the 30day beyond use date).    No concomitant medication was reported.  No treatment medication was reported.    Most recent FOLLOW-UP information incorporated above includes:
Dizziness, Palpitations, Tachycardia, Throat swelling, shortness of breath Narrative:
High Blood Pressure; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure) and NAUSEA (Nausea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant medication details were not reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), DOCOSAHEXAENOIC ACID (OMEGA 3 DHA [DOCOSAHEXAENOIC ACID]), DENOSUMAB (PROLIA), DEXTROMETHORPHAN HYDROBROMIDE (DELSYM), DILTIAZEM, LEVOTHYROXINE, LISINOPRIL, TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HYPERTENSION (High Blood Pressure) and NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERTENSION (High Blood Pressure) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Client has 4 lesions in total. The first lesion is on R. index finger with induration and edema with a central area that is scabbed over.  The area measures about 1"x1".  There are 2 lesions on the R. middle finger. One measures about 1" x1" and it is at the proximal end of the middle knuckle.the 2nd lesion is at the base of the middle finger and it is larger than the 1st.  It measures about 1.5" by 1.5".  There is edema and erythema up to within 1" of the wrist.  All 3 lesions have been opened by the patient and scabs are forming. There appears to be some pus in the proximal lesion of the middle finger.      The abdomen has a 6" x6" area of erythema at the 10 o'clock position from the umbilicus.  there is induration of 3" x 3" in the center.  There is a black center.  No pus is evident.  The area is warm to touch.  Client c/o fever, chills, and pain at abdominal lesion site.  Temp is 97.8 oral. The hand lesions have been present for about 3 days.  The abdominal lesion has been present 2 days.  The client also punctured this lesion and tried to express pus, but none was expressed.
About 5 minutes after injection, I became lightheaded and nearly fainted. The lightheadedness cleared up about 30 minutes after injection.
No other AE reported; temperature excursion; This spontaneous report as received from an unspecified reporter and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On 17-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in pre-filled syringe injection, 0.5 milliliter (ml), lot # 1602284, expiration date 26-SEP-2021, for prophylaxis (dose number, route of administration, and anatomical location were not reported).  It was reported that the dose of the product administered to the patient was stored improperly for the time frame of 30 minutes at a temperature of 31.2 Fahrenheit (F). There was no previous temperature excursion and the Digital Data Logger was involved.  No other adverse event was reported.  This is one of the several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA010448: US-009507513-2101USA009847:
pt did fine-recvd vax 31OCT95 had no fever no rash at all;pt's sister however, devel chicken pos on 13NOV;pt was the index case in kindergarden class & school;pt's mom devel chicken pox 3DEC95
24 hours after injections (separated by >1 inch apart) Left arm from shoulder to elbow was very swollen, red, painful and hot all the way around arm not just at injection site.
Left arm-24 hours after vaccine, patient noticed small area of redness and swelling. 48 hours after vaccine, patient noticed area getting larger, approximately 6" in diameter. Patient called office on 02/09/2018 to report redness and swelling. Had patient to come in to clinic. Patient saw NP on 02/09/2018. NP recommended cool compresses for swelling and ibuprofen for pain management.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 12-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: L003855 and Expiry: 05-FEB-2017) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt developed fever of 103F, inconsolable crying > 3 hours, vomited X 1. Went to ER for full work-up, blood work and lumbar puncture.
Fever,congestion,cough,headache,runny nose,sore throat,very tired receive the flu shot at work
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (product name reported as "HPV;SDV; 10-pack"; lot # J009243, expiration date 23-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 40, unknown and R; 48, 34 and R; 712, 33 and R; 488, 32 and R; 72, 28 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
The first day after the 2nd dose, a big, painful, hard ball formed at the injection site (about the size of a golf ball). The next day, I had a fever twice, headache and very nauseous. I'm on day 3, the site is still very hard and painful, but the swelling has gone down some.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 at 11:00 as dose 2, single (Lot number: EN6207), in left arm and on 30Sep2022 at 18:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Birth control" (unspecified if ongoing), notes: Other medication in 2weeks product=Birth control,. Concomitant medication(s) included: MICROGESTIN taken for contraception, start date: 01Jan2020, stop date: 22Jan2023.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative; Positive, notes: Multiple rapid tests came back positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300033748 Same reporter/patient, same drug/different dose, different AE;
Patient was vaccinated with Pfizer #1 (lot EN9263). on 3/4/2021.  She signed up, with the system in for shot #2 and was allowed to come on a Moderna-only day, and was vaccinated a second time with Moderna #2 on 4/5/2021.  No adverse outcomes or symptoms reported;  counseled by doctor that she does not need additional vaccine. Troubleshooting: The patient did not present her vaccine card at the time of vaccine; she was not in the system; scribe and vaccinator did not ask to see her card (which does say Pfizer #1);  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day