chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had COVID-19 after vaccines; Had COVID-19 after vaccines; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3302), on 12Feb2021 as dose 2, single (Lot number: EM9809) and on 28Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (ongoing); "Antilipid" (ongoing); "Blood pressure" (ongoing). Concomitant medication(s) included: CRESTOR oral taken for blood cholesterol abnormal, lipids abnormal (ongoing); AMLODIPINE oral taken for blood pressure abnormal (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Feb2022, outcome "recovered" (2022) and all described as "Had COVID-19 after vaccines". The patient underwent the following laboratory tests and procedures: Biopsy: unknown results, notes: Declined to provide any test results; Blood test: Nothing turned up; SARS-CoV-2 test: Positive. Clinical course: Caller provided product as Crestor, clarified to Generic Crestor. Lowest dosage. Taken for quite some time and hasn't changed. Amlodipine: Low dose blood pressure medicine. Started 2 years ago maybe. About 4 or 5 months after her last Pfizer vaccine dose she got COVID-19 and developed the same thing (unusual lip reaction) in her upper and lower lips but was worse. Was advised to not have 4th dose, booster, due to this. Acute illness about a week, then lingering weakness following it. Not serious, like having a virus with a low-grade fever. Most recent dose that preceded her symptoms. Was 6 months after the covid-19 vaccine booster before she got covid-19 and then had the lip reaction.  suspects the covid-19 infection itself caused her lip reaction, not the covid-19 vaccine booster. Takes a low dose blood pressure medicine and cholesterol medicine that were taken prior to any of the covid-19 Vaccines. No other medical conditions, healthy as a bear. Investigations: Testing: Because of the concern with the lip, she went to several different physicians.  First the primary care provider who recommended an ENT. Had an ENT consult who found no explanation. All providers are pointing their fingers at covid-19 infection. Went to dermatologist who didn't know anything either, recommended a biopsy and blood work. Nothing turned up on any blood work. Decided to do a biopsy. Declined to provide any test results.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Received immunization-Varivax #2 at 10:10 am 5/18/07 call from mother at 4:31 pm-"Rash on trunk, arms and now going up to face" while speaking to nurse.
29OCT96 shoulder stiff;30OCT lt rib sore;31OCT tingling rt fingers;3NOV add fatigue & muscle weakness;5NOV swollen foot;t100 6NOV;7NOV appt w/MD muscle so weak can barely walk, hands, knees & feet swollen;to MD 13NOV96;trouble walking,sit;
Per patient - She developed a round like quarter size of redness around the injection site 2 days after the shot but no fever nor pain. Today patient happened to shop at our location and just wanted to show us the  reaction. Her right arm has a large patch of redness with  size of  about 6-8 inches x 4-6 inches, running from below the injection site close to her elbow. She said there's no pain and no fever, just feeling warm in the red area. Patient was instructed to take Claritin for allergy and to contact her PCP if the redness changes color or fever.
Pt received two injectins on 03/20/2002. Hav #1 and DTaP#2 within 12 hours pt developed a reaction at the injection site. A 8 1/2 x 7 1/3 cm erythematous macule.
Vax recvd 28AUG91, slight local swelling & slight fever 1st day; 30AUG91 hives appeared on body & sent home; Md called & referred mom to clinic;
arm was red; arm was warm; arm was itchy; rash was 2 inches long and 1 inch wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm was itchy) and RASH (rash was 2 inches long and 1 inch wide) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131.20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm was itchy) and RASH (rash was 2 inches long and 1 inch wide). At the time of the report, VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm was itchy) and RASH (rash was 2 inches long and 1 inch wide) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included unspecified lotion. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Red  blotchy itcy approx 3" diameter at injection site. Appeared 48 hours later
Acute STEMI presentation - initial cath with no culprit lesion identified. with history of type 2 diabetes, permanent atrial fibrillation with intrinsically controlled heart rates, and long term anticoagulation with Xarelto, Obesity, hypertension , hyperlipidemia, DVT and right sided carotid endarterectomy admitted for further evaluation of chest pain progressively worsening since receiving COVID vaccine booster 2 days prior. ECG was consistent with anterior STEMI. Initial emergent LHC was felt to show TIMI 3 flow in all vessels and moderate diffuse disease - the films were reviewed by multiple interventionalists and the consensus was that no culprit vessel could be identified. ED and hospital admission was within 2 days of receiving the COVID vaccine.
Persistent shoulder pain. Injection administered too high in shoulder. Perhaps into bursa. Very painful for the first two days, then pain diminishing, but on day four, inflamation in shoulder joint. Saw my Dr, who suggested that this is suspicious for improper vaccination technique.  Recommended that I make a report. Symptoms, pain in shoulder joint and over scapula, down back side of left arm. Numbness in the morning in hand, resolving as day passes.  Will begin physical therapy week of 4/6.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and on 05Jun2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). There were no concomitant medications. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral treatment started on 31Aug2022 and stopped on 05Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Starting 10/21, internal vibrations felt especially during times of resting and greater intensity when I was feeling unwell with a cold or virus. This has continued for over 15 months.
pt already received one dose of Pfizer Comirnaty (10/3/23) and returned to pharmacy and also received Moderna Spikevax (11/7/23).   Pt worried over receiving two doses
Rash and blisters - antibiotic Prednisone, Vicodin - Neurontin.
This spontaneous report from a contactable medical assistant calling on behalf of the physician and from a contactable physician. A 61-year-old female patient received PREVNAR 13, (lot# L13063; Exp. 01Aug2016), intramuscularly in right arm on 21Feb2016 at 0.5 ml, single. Medical history included high blood pressure and blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced a red hot to the touch itchy red injection site on 22Feb2016, her face and her legs were burning on 22Feb2016. Therapeutic measures were taken as a result of events included Dexamethasone. The events did not require emergency room or physician visit; the patient was not admitted to the hospital. The patient recovered from the events. The physician stated that the patient provided to him/her information regarding the reported adverse events with the use of the vaccine. The physician considered the vaccine had a causal of effect to the adverse events. Follow-up (22Mar2016): New information reported from a contactable physician includes: no hospitalization, emergency room or physician visit for the events, confirmation that the patient provided to the physician information regarding the reported adverse events with the use of the vaccine, causality assessment. Follow-up attempts completed. No further information expected.
pt recv vax 14 days later mother came down w/classic chicken pox;rx Zovirax, uneventful recovery;
Broke out in a red rash on 27JUL92 @ noc; rash spread on 28JUL92; red, bumpy, itchy & blistered; on 29JUL92 eyes are almost swollen shut;
Side effect on the face; Swollen,it got bigger; Sort of dark looking\ side effect on her face and skin which is dark looking; It was very upsetting; Damage to their face; Damage to their skin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting) and FACE INJURY (Damage to their face) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting), FACE INJURY (Damage to their face) and SKIN INJURY (Damage to their skin). At the time of the report, VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting), FACE INJURY (Damage to their face) and SKIN INJURY (Damage to their skin) outcome was unknown.            No treatment medication details was reported.   This case was linked to MOD-2021-250415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and patient's contact details added, updated event information. On 10-Aug-2021: Follow -up received on 10-AUG-2021 contains Non Significant information On 12-Aug-2021: follow-up received and additional AE added.
Returned and reported a systemic fine raised rash, complaints of purpura. Denies difficulty breathing. Went to the ER, and was given po Benadryl and Pepcid.
Patient presented for swelling of her lips with associated burning/pain 4 days after first dose of Pfizer Covid vaccination. No strong clinical correlation of symptom onset and vaccination, however unable to completely r/o as a cause. Patient also reported onset of abdominal pain, diarrhea, and nausea after lip swelling started. Treated for angioedema vs allergic dermatitis and monitored on outpatient basis. No signs of anaphylaxis or airway compromise. No other systemic rash or signs of allergic reaction noted.
Right sided facial and mouth numbness...felt like she received novacaine. Numbness lasted into the evening, slowly subsiding. Continues with slight numbness around the mouth this morning.
Developed a rash immediately after receiving the first dose; This is a spontaneous report from a non-contactable consumer or other non-HCP. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced developed a rash immediately after receiving the first dose on an unspecified date. Reporter wanted to know if it would be okay for patient to get the second dose. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from Health Care Professional on 14-Aug-2018.  This case was linked to 2018SA226820, 2018SA226818, 2018SA226774, 2018SA226816 and 2018SA226817 (same reporter). This case involves a male patient who was vaccinated with a dose of MENACTRA that were used around the time or after the time of the excursion (excursion for 45 minutes, but caller states the excursion was actually for 9 days, starting in May, and ranged from 48-49 f) (Batch number: U5833AA, expiration date: 25-Feb-2018, dose: 0.5 ml, route : intramuscular and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was a case of potential medication error due to incorrect product storage. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender : none.
101.4 fever (onset around 2am; reduced to 99.8 after approx. 10hrs), severe headache (12 hrs; intermittent for 2 days following - treatable with ibuprofen), sharp joint pain (sporadic lt hand 1st MCP joint 1 hr), severe lt shoulder pain (delayed onset; 6hours-15hrs; reducing severity soreness following 2 days), chills/body ache (4hrs), night sweats (8hrs; sporadic hot flashes 2nd night & day), excessive thirst/dry mouth (3hrs),  chest tightness (1hr), extreme fatigue (slept 19 hours; 10pm-5pm); sore rt elbow/wrist 2nd day following w/ hot flashes & fatigue intermittent
The headaches and dizziness, were actually associated with LOW BLOOD SUGAR. Did not realize until the week of 4/26/21.  I do NOT have diabetes although can run on the higher end.    I would wake up below 70 and after eating still not get past 80.
It started the same day of the vaccine, I had high fever, headache, brain fog, chills and body aches. It last for about for days.
DIZZINESS, NAUSEAS, INCREASED IN BLOOD PRESSURE, DECREASE IN BLOOD SUGAR
pt recvd vax & 24DEC92 exp rash that was pimpled w/white center on lower lt abdo; reporting MD indicated that rash was treated w/Cortisone cream but that the medication did not help; 4JAN93 reporting MD indicated pt exp rash in other areas;
COPD; Eczema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Chantix, reaction(s): "Stomach ache". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization), outcome "unknown", described as "COPD"; ECZEMA (hospitalization), outcome "unknown". Clinical course: Patient asking if the Chantix was still available in the market. She was taking Chantix before. She never had a bad side effects, except for stomach ache. She was on the hospital right now and she had COPD and eczema. She mentioned that she really need it and she really help. And said she got booster shot from us.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300187597 same patient, different drug/event;
1. Day 2, 9:25 AM Pt reported to employee health "bronchitis-type" symptoms, low grade fever, night sweats  2. Day 2, later that date: reported symptoms that date of atrial fibrillation; patient later reported through employee health that he went to his partner cardiologist, had atrial fibrillation documented, started on metropolol 50 mg, and sx lasted 12 hours. 3.  Day 7: employee reported for take check and disclosed that he had a prior history of atrial fibrillation.  Note - this was not disclosed in screening materials; patient checked "no" on question 13 on consent form which asks "do you have any other heart condition for which you are under the care of a doctor?" 4. Day 12: employee health reports patient still on metropolol; no further symptoms
Extreme headache, dizziness, fever, Extreme muscle ache, ringing ears, flashing lights, swelling tongue, exhaustion
Patient ID: 75 y.o.   Admit Date:  8/8/2022   Discharge Date:   8/12/2022   Discharge Diagnosis:  Principal Problem:   Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure Active Problems:   Pneumonia due to COVID-19 virus   Elevated troponin   COPD (chronic obstructive pulmonary disease)   HTN (hypertension)   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin     Hospital Course:  75 year old female was admitted for CHF exacerbation and Covid-19 infection. She has been treated with Remdesivir, steroids and empiric antibiotics. TTE show 50-55% LVEF. Cardiology recommend continuing BB. She will be discharged home today with hospice services per family request. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.3 °F (36.3 °C) Heart Rate (Monitor): 64 Pulse: 58 BP: 132/69 Respirations: 16 SpO2: 97 % O2 Flow Rate (l/min): 0 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema Neuro: alert   Consults:  IP CONSULT TO PULMONOLOGY IP CONSULT TO CARDIOLOGY IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:   TTE   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Fair
DVT in upper left arm; Alopecia Areata - sudden loss of patches of hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EN6208) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ALLEGRA. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (disability, life threatening) with onset Jun2021, outcome "not recovered", described as "DVT in upper left arm"; ALOPECIA AREATA (disability, life threatening) with onset Jun2021, outcome "not recovered", described as "Alopecia Areata - sudden loss of patches of hair". The events "dvt in upper left arm" and "alopecia areata - sudden loss of patches of hair" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, alopecia areata and included treatment with steroid shots for alopecia and apixaban (ELIQUIS Rx) for DVT (deep vein thrombosis). The patient had not received any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed as COVID-19. The facility type vaccine was Pharmacy or Drug Store. It was unknown whether the patient had been tested for COVID-19 since the vaccination.   Follow-up attempts are completed. No further information is expected.
pt recv vax 24JUN98 & 30JUN98 pt devel a fever that was ongoing for @ least 30 days;f/u info reported that fever of 99.3-101 lasted 1 & 1/2mo accompanied by flu-like sx, back aches, chills, & no site irritation;
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.