chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt stopped talking, and have a fever of 103.7 deg. F. for 3 days. He started echolelic talking after 1 month of vaccination. Regressive speech. *Follow-up report on 3/7/03: PT has not recovered: 1) Maintains Dx of "moderate" in autism spectrum by medical professional. 2) Continuous learning disabilities especially speech & language, 3) Behaviors typical of his Dx (avoids eye contacts, etc.). Add'l comments from reporter: 1) PT was functioning w/in "normal" limits for early development prior to vax. 2) PT was developing early speech (mama, dada, baba, no, etc) prior to vax event, 3) PT had fever and discomfort after fax that subsided after a few days, 4) Normal behaviors (eye contact, interaction) and speech development slowed or ceased after vax.
11/5/03: Right deltoid full ROM, no fever, rash or bruising, no system symptoms, sensation WNL equal strength. Advised Ibuprofen for muscle tenderness. RTC on 11/14/03 with continual symptoms. Continue same care.
7 days after vaccination I experienced fatigue and chills,  14 days after vaccination I developed welts, redness, and itching in a large area all around the injection site.
inappriate schedule of vaccine administration; The day after my second dose of was administered was when I noticed the shingles on my chin; This is a spontaneous report from a contactable consumer (Patient). A 32-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6206), via an unspecified route of administration on 19Feb2021 (at the age of 31-year-old) administered in Arm Left as a single dose for COVID-19 Immunization at School or Student Health Clinic. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6206), via an unspecified route of administration on 19Feb2021 at 21:15 pm administered in Arm Left as a single dose for COVID-19 Immunization at School or Student Health Clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 13Mar2021 at 07:00 AM, the day after my second dose of was administered was when I noticed the shingles on my chin. From there is progressed into full blown shingles. Therapeutic measures were taken as a result of the event and treatment included Valtrax.The outcome of the event was recovered for shingles and unknown for another event.
Red rash/itching/hardened swelling at injection site (about six inches in diameter). No other symptoms or issues, although I did notice that it made my skin condition (hidradenitis supporativa) flare immediately after the injection.  I researched symptoms online and realized it was "Covid Arm" and have monitored the area to make sure it does not worsen.  I am taking benadryl 1x daily.
Received DTAP on Tuesday, went to school the next morning with an area of induration the size of a mosquito bite, by 5 pm most of L upper arm red swollen. used cold packs and Ibuprofen but area but it continued to swell and was seen in ER at 7:30 pm by PA who states arm was edematous and red from shoulder to elbow. Pt was able to move arm without problem but complained of pain and tenderness. He was seen at HD again on 5-11-06 and area remained tender and swollen from shoulder to elbow. 5-12-06 PHONE CALL to mom states area is not as red but is still swollen and has spread alittle more.
Swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). On 21-Jan-2021, VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-11740 (E2B Linked Report).; Sender's Comments:  MOD21-11740:Crosslinked: Same reporter
woke up next morning at 3AM with cold sweats, severe arm pain, could not lift arm. generalized weakness, nausea, felt like she was gong to pass out. Pt applied cold compress and took ibuprofen. Symptoms resolved by that night.
Patient requesting walk-in COVID-19 vaccine. Patient reported history of anaphylaxis to shellfish and iodine products during pre-vaccine screening and was told she would be observed for 30 minutes post vaccine, per protocol. Patient verbalized understanding. Vaccine administered. Patient observed for adverse reactions and verbally asked by nurse how she was feeling. Patient stated she was fine.  Approximately 15 minutes after vaccine was administered, patient requested some water, which she was given.  Nurse asked how she was feeling. Patient reported "It feels like I have something stuck in my throat." Sensation did not resolve with sips of water, nurse instructed clerk to call 911. Emergency cart was brought next to patient. Nurse drew up Epi. Patient was not in distress and continued to breathe unlabored. Nurse took patient's vital signs: heart beat was strong, steady, and a normal rate. BP was slightly elevated. Nurse uncertain whether clinical picture was consistent with anaphylaxis. Patient continued to breathe unlabored and stated throat felt the same: no better, no worse. Nurse called Clinic Nurse Supervisor by phone. Nurse Supervisor stated ?don?t give Epi unless you have to.? Nurse drew up IM Benadryl. Nurse used flashlight to look into patient?s throat and saw swelling. Nurse quickly explained to patient that this did appear to be mild anaphylaxis and that she did need the medications. Nurse administered Epi and then IM Benadryl, both to L thigh. EMS arrived shortly after and assessed patient. Vitals continued to be stable. Patient was transported to hospital.   Nurse called patient today (2 days post event). Patient reports is now doing fine. Patient reports at hospital she developed "itchy rash" on her neck. Patient was given additional dose of Benadryl prior to being discharged.
Client began to complain of feeling like her throat was swelling and opening. 50mg of Benadryl given. 4 min later client stated they were feeling better. Client's vitals remained stable. Released to personal car at 3:15pm
no adverse effect; 2 doses administered over the age of 65 years and more than 5 years apart; This spontaneous report as received from a pharmacist refers to a 86 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date in 2013 and 2019, the patient was subsequently vaccinated with first and second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, anatomical location, Lot # and expiry date was not reported) for prophylaxis (inappropriate schedule of product administration). On an unknown date in 2015, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (dose, anatomical location, Lot # and expiry date was not reported). There was no adverse event reported.
Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unspecified dates, the patients were administered improperly stored VARIVAX (lot # M035142 with expiration date of 03-AUG-2018; strength, dosage, frequency and route unspecified) for prophylaxis which was reconstituted with sterile diluent(STERILE DILUENT). Sterile diluent (STERILE DILUENT) was not involved in the temperature excursion. No adverse effects were reported. Temperature was from -14 to -10 degree C (-13.9 degree C) for 2 hours (frozen vaccine). There was no previous excursion. This is one of 4 cases received from the same reporter.; Sender's Comments: US-009507513-1709USA001898: US-009507513-1709USA001897: US-009507513-1709USA001896:
Was in bed 3 more days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bedridden (Verbatim: Was in bed 3 more days). The outcome of the bedridden was recovered/resolved (duration 3 days).   The reporter considered the bedridden to be related to Shingles vaccine.     The company considered the bedridden to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR043586   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by the patient via interactive digital media. The patient said he or she was convinced to take a shingles shot and it was the worst ever.  The patient was in bed for 3 days. The patient said would never encourage anyone to take a shingles shot.  That was how it worked for him/her and was horrible. For tolerance to the 2nd dose refer case US2023AMR043586.; Sender's Comments:  US-GSK-US2023AMR043586:Same reporter
Awoke with 2/10 mid-sternal chest discomfort described as "a hole" or emptiness. Unresolved with antacid and Pepto-Bismol.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02May2021 as dose 1, single (Lot number: 012A21A), in right arm, on 31May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 013F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Possible Sjögren's" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: Treatment of COVID-19; (28Jun2022) Positive, notes: Retested Positive on 3rd day after treatment symptoms worsened. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. The case was considered non -Serious. The patient received COVID treatment. Other medication in 2 weeks: Unknown. Anti-viral details: product for COVID 19 Treatment, Brand was Pfizer, treatment start date: 21Jun2022, treatment stop date: 25Jun2022, Indication: Treatment of COVID-19. Reported Event: Took 5 days dose of Paxlovid beginning 21Jun2022. Felt better for 2/3 days. Retested Positive on 3rd day after treatment symptoms worsened. The patient now at 4Jul2022, still sick and symptomatic. Adverse events start date 19Jun2022. Ae resulted in [None of the above]. The patient was Recovering. Treatment ae: Yes. AE treatment Prednisone 20mg, Amoxicillin 125mg, OTC meds.  No follow-up attempts are possible. No further information is expected.
Site inflammation, redness, puffiness, growing puffy everyday, hard on the injection site.
pt recv vax 1JUL95 & 19NOV96 pt exp breakthrough chickenpox;
patient had significant seizures resulting from the Covid infection; two weeks later tested positive for Covid; two weeks later tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a patient that a 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that a pharmacy technician (21-year-old, female) who received her first dose of the Pfizer Covid- 19 vaccine in Jan2021. Caller states 3 weeks later she tested positive for the Covid infection and has never received the second dose. Caller was asking if she should administer the second dose or if she needs to restart the series. It was answered that the vaccine did not contain Sars-Cov-2 and cannot give you the Covid infection, addressed that each patient can react differently and it would be up to the providers discretion on whether a specific patient should receive a vaccine. On an unspecified date, the patient experienced patient had significant seizures resulting from the covid infection, two weeks later tested positive for covid. It was asked by the reporter that if the Pfizer Covid-19 vaccine would trigger these seizures as well. No Serious was reported. Reporter seriousness for Received first dose of Pfizer COVID-19 vaccine in January later she tested positive; never received the second dose was unspecified. The patient underwent lab tests and procedures which included covid resulted as positive as first dose of Pfizer COVID-19 vaccine in January and '3' weeks later she tested positive. The outcomes of events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events seizure, drug ineffective and covid-19 and the suspect drug BNT162B2. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021822840 Same reporter/ drug/ AE, different patient
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date; Dose 1 taken on 28-Feb-2022 and Dose 2 Taken on 08-Apr-2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Feb-2022 and Dose 2 Taken on 08-Apr-2022) in an 84-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date). 08-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Feb-2022 and Dose 2 Taken on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 08-APR-2022/ Dose administered after 30-day Use By Date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Feb-2022 and Dose 2 Taken on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. The vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-569767 (Patient Link).
Narrative:  COVID infection following COVID vaccine series after previous COVID infection 03/29, Pfizer, dose #1 04/27, Pfizer, dose #2 02/27 pt cc:myalgias, fatigue, fever, exposure: unknown 03/01 COVID swab, result: detected 03/09 ABG result: i-pH 7.47, i-PC02 34.0, i-P02 70, i-HCO3 24.9 03/09 FERRITIN: 548.3 03/09 LACTIC ACID: 1.53 03/09 PROCALCITONIN <0.05 03/09 DDIMER: 0.24 03/13 pt admit to Medicine cc: SOB dx: Acute Hypoxic Respiratory Failure due to COVID-19 Pneumonia LOS: 6 DAYS 05/11 COVID swab, result: not detected 05/11 FIBRINOGEN: 508 05/11 DDIMER: 1.33 05/11 ESR: 33 09/20 COVID swab, result: detected 09/21 BinaxNOW COVID-19 Ag result: not detected 09/21 clinically resolved
Lightheadedness, dark blue bump on my right palm of my hand (blood clot in artery?) and pulsing blood vessels with slight pain. Also feel weak and like i can feel the blood pulsing through my blood vessels all over my body
Within 6 hours post vax pt broke out in hives. Pt was treated with Solumedrol IM and Benadryl po.
Injection site was moderately sore; I felt extremely tired and fatigued; chilled to the bone alternating with hot spells; This is a spontaneous report from a contactable consumer.  A 53-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), into the left arm on 29Jan2021 at 10:30 at single dose for COVID-19 immunization. Age at vaccination 53 Years. The patient had received first dose of BNT162B2 on 09Jan2021. The patient had no allergies to medications, food, or other products. Medical history was none. Concomitant drugs included Prozac  daily and Lyrica one daily. The patient reported that the injection site was moderately sore. The main side effect started 24 hours post shot. She felt extremely tired and fatigued as well as chilled to the bone alternating with hot spells.  No body aches. No other effects. No treatment was received. Resolved in 24 hours.
Fever over 100 hours after getting vaccine. When I woke up I had a huge red rash where the shot is. I took my temperature again and its around 101. Nausea and chills.
PT self reported feeling light headed and dizzy approxiamately 10 minutes post vaccination. Pt was seated and blood pressure taken (BP:183/105, HR:108). Pt relocated to vaccination room and instructed to lie down with legs propped on a chair. BP retaken approxiamately 15 minutes later by onsite nurse practitioner (BP: 181/104, HR: 105). Pt monitored and then given emergency supply of blood pressure medications that they normally take same time each evening around when vaccine was administered (losartan 50mg x1, HCTZ 25mg x1, metoprolol succ ER 50mg x1). Vitals taken again 20min later (BP: 163/101, HR: 101). Pts color returning and positioned upright. Vitals taken 20 min later (BP: 152/93, HR:97). Pt personal cardiologist consulted, recoomended pt return home since vitals were lowering and trending back to normal (base BP: 130/80, HR:85). Pt had prior to vaccination had stressful interaction with another pt and stated  its been a "stressful weekend". Pt had also previously been placed on a "drug holiday" from levothyroxine by their endocrinologist 3 weeks prior to advers event.
I woke up at 1AM and had fever. 101.4 or around that range, it was the the same the next day. It came down on the 3rd day. I also had itching and redness around the injection site for about 10 days. It was about 5 to 6 inches around in diameter. Lots of lung pain which I have had which is my chronic situation from COVID (lung pain and SOB). I had much more of a cough.    I just messaged my infectious disease doctor.
Pressure on face; Did not feel right; possible allergic reaction; tachycardia; swelling; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (possible allergic reaction), TACHYCARDIA (tachycardia), SWELLING (swelling), FACIAL DISCOMFORT (Pressure on face) and MALAISE (Did not feel right) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ALLERGY TO VACCINE (possible allergic reaction), TACHYCARDIA (tachycardia), SWELLING (swelling) and MALAISE (Did not feel right). On an unknown date, the patient experienced FACIAL DISCOMFORT (Pressure on face). At the time of the report, ALLERGY TO VACCINE (possible allergic reaction), TACHYCARDIA (tachycardia), SWELLING (swelling), FACIAL DISCOMFORT (Pressure on face) and MALAISE (Did not feel right) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant products - not provided treatment products - Steroids   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: NNI
Fever day 1 100, fever day 2 - 102.7 fever day 3 - 103,  nausea, diarrhea, massive headache
Moderna COVID-19 Vaccine: My left arm was very sore starting in the evening of 1/6/2021. This soreness got worse over the next 2 days and then tapered off over the weekend.  On 1/11/2021, I started having pain in my left axillary region.  This pain increased into 1/12/2021.  Also, on 1/12, my left upper arm started hurting.  On 1/13, I still had pain in my left axillary region, and thespian in my left upper arm worsened.  Also, on 1/13 my left upper arm started itching.  Around 5pm on 1/13, I had a chance to look at my left upper arm and there was a large reddened area to my left upper arm which included the vaccine injection site.  This area was warm to touch.  About 5:30pm, I took 25mg of Benadryl.  I took another 25mg Benadryl at 11pm.  This morning (1/14), the redness is fading to the area on my left upper arm though itching remains.  There is slight pain to the area.  The pain to the left axillary region is much better-barely noticeable.  I reported this event to County Health Department and to my primary physician.
SHINGLES DEVELOPED JUST BEFORE SECOND VACCINNATION, BUT I DIDN'T RECOGNIZE ISSUE.  SCHEDULED DOCTOR APPOINTMENT WITH FAMILY PRACTITIONER TWO DAYS AFTER SECOND VACCINATION, AND HE PRESCRIBED STEROID TREATMENT.  TREATMENT EASED SYMPTOMS AND TOOK APPROXIMATELY 4 WEEKS FOR MAJORITY OF DISCOMFORT RESOLVE.
Patient called reporting she had a fever and was nauseous. I recommended she go to her PCP. Patient called back after being seen by PCP. They gave her something for the nausea and told her to take tylenol for the fever.