chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels something in chest; Caller states it was a Pfizer shot, the third dose; Caller states it was a Pfizer shot, the third dose; This is a spontaneous report from a contactable consumer (patient).   A 91-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single (booster) dose for COVID-19 immunisation.  Medical history included pacemaker from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient reported that "he feels something in chest" in 2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: normal on an unspecified date.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
swelling the size of an orange on 15MAY92, seen on 18MAY92 w/hard nodule approx 3/4-1" in diameter; red area 1 1/2" square; treated w/DPH;
(R) thigh reddened warm to touch alittle puffy area. No temp noted given BENADRYL. Cool compresses better in 48 hours.
Patient was administered only the liquid component; Patient was administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA603A, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporter's comment:  The health care professional reported a patient was administered only the liquid component of the Menveo vaccine. Consent to follow-up was provided by phone or email. Additional supportive information: Only the liquid component of the Menveo was administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Approximately 1 month after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: Coughing, Minor breathing difficulty, Slight fever and it prompted me to take the COVID-19 test which resulted to a positive test result. I called my family doctor and he prescribed me with Paxlovid for 5 days and as of today, 06/22/2022 I have completed all 5 dosage of Paxlovid and have been feeling so much better than before except for a little fatigue.
Information has been received from a physician concerning a 28 year old male with no allergies or medical history who on 17-AUG-2006 was vaccinated SC with a dose of Varivax (lot # 653308/0440F). Concomitant vaccination on the same day included a dose of tetanus toxoid and a dose of Recombivax HB. On 01-SEP-2006 the patient developed a fever which was followed by a rash on his trunk, extremities, and face. The patient was unable to go to work for a few days. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. The patient's events were considered to be disabling by the reporter. Additional information has been requested.
After receiving 2nd dose of Pfizer Vaccine, I am experiencing nausea,  vomiting and a headache.
GI Intolerance; numbness; tingling; swelling of the throat; fatigue; headache; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced gastrointestinal (GI) intolerance, numbness, tingling, swelling of the throat, fatigue, and headache on an unspecified date. The clinical outcome of GI intolerance, numbness, tingling, swelling of the throat, fatigue, and headache was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Dose received was most likely up to 3 times recommended. No dilution before drawing up 0.2 ml from dose vial. Diluent of 1.3 ml was also drawn into the same syringe. All was administered to patient. Day after vaccine, patient complained of swollen and hot arm in the arm the vaccine was administered.
pt c/o scalp itching & skin rash on body that started 8JUN93 also c/o headache, sore throat; client informed of poss side effects, rash, itching from IG & to see MD for tx of sx & to r/o other poss; prescribed DPH & pred;
Patient got vaccines on 09/30/2015. Started Amoxil on 10/01/2015 for OM. Band Aids at injection site were not taken off until the morning of 10/01/2015 by patients grandmother. On 10/02/2015 patients mother noticed a rash from knee to hip on front of left and right thighs. Patient had no SOB, difficulty breathing, or fever. No change in appetite, sleep, or activity. Per mom the rash did not spread or worsen. Per PCPs notes patient did not take antibiotic on 10/04/2015 or 10/05/2015.
Patient's arm is red, warm, swollen and tender. The warmth is diminished but is still red and tender.
Vaccinated pt (per pt report) admitted to inpatient facility. No info on vaccine available
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Blood pressure high, Diabetes, Blood cholesterol abnormal, Sleep disorder, Thyroid disorder and Arthritis. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure, LOVASTATIN for Cholesterol, INSULIN ASPART (NOVOLOG) for Diabetes, TRAMADOL and GABAPENTIN for Fibromyalgia, LORNOXICAM for Pain, TEMAZEPAM for Sleep disorder, LEVOTHYROXINE for Thyroid disorder, UBIDECARENONE (COQ 10), MULTIVITAMINS;MINERALS, CURCUMA LONGA ROOT (TURMERIC [CURCUMA LONGA ROOT]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            This case was linked to MOD-2021-371792, MOD-2021-371898.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Patient age and current conditions were updated, route of administration and anatomical location added for suspect vaccination.
Approx. 2 inch red circular area R. Deltoid. Area is hard and warm to touch. Told to treat with cold compress to area and Tylenol prn pain. Avoid heavy lifting.
No adverse event; Expired vaccine administered administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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 17-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient).    No concomitant medication information was provided. It was reported that there was an instance where an expiration date was incorrectly documented for lot number 043h22a. it expired 8Jun23 but was administered to a patient 17Jun23 . Reporter was looking for guidance if the patient needs another dose or not. The vial size was reported as 2.5ml. It was unknown when the vial was initially stored in the refrigerator. It was confirmed that the vial had not undergone temperature excursion issue.  Patient had had reported any adverse event at the time of report. No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729650, US-MODERNATX, INC.-MOD-2023-729716 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2023: Follow up received contains Non-significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729650:Same reporter US-MODERNATX, INC.-MOD-2023-729716:Same reporter
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 25-SEP-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Reported bumps over body X 3 weeks, pruritic and spreading today. Papules and vesicles (about 30) on trunk and still pruritic. Afebrile. No known exposure to Chickenpox.
about 330PM grandma noticed pt's hands, legs & around lips were blue & called MD & who saw pt about 4PM no problem found was told to watch carefully 1PM hands again blue & lips blue; pt taken to ER adm to hosp for observation; t100.7 ax;
This case was reported by a healthcare professional and described the occurrence of needle stick injury in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included HIB (non-gsk); Sanofi Pasteur MSD given on 11 May 2010; pneumococcal vaccines (non-gsk); Wyeth Labs on 11 May 2010; ROTATEQ (non-gsk); Merck given on 11 May 2010. On 11 May 2010 at 12:00 the subject received 1st dose of PEDIARIX (unknown route, left thigh), and experienced needle stick injury and pharmaceutical product complaint. The plunger came out of the syringe while in the subject's thigh during aspiration. It was reported that it had not been checked whether the plunger was screwed in tightly prior to administration. The product was discarded and therefore not available for return. At the time of reporting the outcome of the events was unspecified. This case was reported as a product complaint and is one of two cases from a doctor's office reporting that the plunger came out of the syringe for two PEDIARIX prefilled syringes with the same lot number (see case A0859171A for details of the other case). Follow-up information received from healthcare professional on 11 June 2010: PEDIARIX (.5 ml) was administered intramuscularly. The healthcare professional reported the diagnosis as plunger malfunction. The events resolved on 03 May 2010. The events did not recur following subsequent administration.
Complained that arm "hurt" after a couple hours after injection given (specified it was the PNEUMOVAX vaccine which was given in the right arm). Pt applied warm compresses was not seen in clinic for follow up, just called to complain.
Patient blacked out for 1-2 seconds after the shot, then quickly recovered. Had patient wait in the shot room for 20 minutes, but no further issue. Patient was happy to get the shots.
Rash all over body and come backagain next day; Rash all over body and come backagain next day; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient 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 24Aug2021 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 08Sep2021, the patient experienced rash all over body and come back again next day, on 09Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with diphenhydramine (BENADRYL).  The clinical outcome of the events rash all over body and come back again next day was resolving at the time of this report. The 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 14Aug2021 at 15:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Lot number: FM9993) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Percocet allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 03Apr2023 to 08Apr2023.   No follow-up attempts are possible. No further information is expected.
Day 0-Severe left arm pain during injection and after with severe swelling to injection site a few hours later.  Injection pain and swelling lasted 4 days Day1- In addition to above symptoms, severe left antecubital pain, swelling, bruising to recent MRI contrast dye site (4 days prior).  Severe left axilla swelling and continued near gumball-size for 2 weeks.  Left axilla lymph node swelling continues but decreased in size persisting more than 6 months now. Day 3- Low grade fever 99.5.  Muscle aches, joint pain, especially to left elbow. Left arm with occas numbness, hot/cold. Day5- headaches, muscle aches, heart pounding, palpitations, high blood pressure, intermittent chest pains.   All symptoms persisted intermittently through week 3
Vomiting, diarreaha, fever, shivering.  Lasted about 4 hours
I ended up having a very bad reaction to fire ants and was placed on steroids by my doctor. It went away and returned 3 weeks later. I went back to the doctor who gave me another steroid shot and it cleared up. The doctor mentioned that this is the 10th patient that he has had that had an allergy that was treated by prednisone and it came back which made begin to wonder if it was related to the vaccine.
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8730), in right arm and on 18Apr2021 as dose 2, single (Lot number: EW0161) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Dec2021 as dose 3 (booster), single (Lot number: 070H21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ; METHOTREXATE; CLINDAMYCIN; DOXYCYCLINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment included PAXLOVID from 17May2022 to 22May2022.  Follow-up attempts are completed. No further information is expected.
After a periodontics dental cleaning, one week after injection I had I severe pain and inflammation of my facial nerve on the side is the cleaning. I have had a lot of similar treatments in the past and did not have an inflammation response like this. I believe it was related to the vaccine.
I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Pt. had 1 1/2-2 inches red raised bump on her (R) arm SQ adverse reaction to injection. Varicella VIS 3/13/08.
Flesh colored pruritic pinpoint papular rash arms, torso after vaccines. No constitutional symptoms. On Wednesday gave Benadryl in PM. Parent informed provider 4 days after visit that child had same type of reaction on 9/78/00 after 1st Hep A, but not previous Hep B vaccines.
pt started to faint and was nauseous.  She never lost full consciousness -- she closed eyes but with cold compress and touching her face she regained consciousness. We did call EMS jus in case but pt regained full consciousness and was able to stand on her own before they arrived and did not want to wait.
Pain and swelling at injection site. Some itching reported. Ice packs and diphenhydramine given to patient.
Fever to 104F, rash started 24 hrs later then spread 1-2 days later, hot, painful at injection site. tx: Bactrim, Benadryl.
This spontaneous report as received from a licensed practical nurse refers to a 5 year old male patient. The patient's medical history and concurrent conditions were not provided. On 26-FEB-2014 the patient was vaccinated with a dose of PROQUAD, with an expiration date of 23-FEB-2014. Information regarding dose, route and lot number was not provided. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Immediately after receiving vaccine patient was diaphoretic and experienced syncopal episode. Regained consciousness after 10 seconds. symptoms resolved.
Soreness around surgery area; Agitation around surgery area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness around surgery area) and AGITATION (Agitation around surgery area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (shoulder surgery).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness around surgery area) and AGITATION (Agitation around surgery area). At the time of the report, PAIN (Soreness around surgery area) and AGITATION (Agitation around surgery area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.      This case was linked to MOD21-076332. (E2B Linked Report).; Sender's Comments:  MOD21-076332.:
Information has been received from a registered nurse concerning her son (age unknown), who on 06-DEC-2007 was vaccinated with a first dose of Hib conj vaccine (OMPC).Subsequently the patient experienced a low grade fever of 99.2F and has been crying. The patient's temperature was measured rectally. The patient did not seek medical attention. At the time of the report, the patient had not recovered. No product quality complaint was involved.
Patient is an employee with the Hospital. Employee received vaccine at 1/6/21 at 0915. She was released after a 15 minute monitoring period.  Patient accompanied to ER by Employee Health Nurse at 1000. C/o dizziness, itchy all over, and blurred vision. Employee seen by MD. Diphenhydramine 25 mg IV administered. discharged home at 1150.