chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site; chills; tiredness for 3 to 4 days; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site erythema, fatigue and chills. On an unknown date, the outcome of the injection site erythema and chills were unknown and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, fatigue and chills to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced tiredness for 3 to 4 days. The reporter did not consent to follow-up.
Covid-19 vaccine breakthrough case. Dose 1 Moderna 3/13/21 lot #002B21A. Dose 2 Moderna 4/10/21 lot #025B21A.
LOSS OF SENSE OF TASTE; CHILLS; EXTREME FATIGUE; LOTS OF NAUSEA; NO ENERGY TO DO ANYTHING; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced no energy to do anything. On 05-APR-2021, the subject experienced loss of sense of taste. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced extreme fatigue. On 05-APR-2021, the subject experienced lots of nausea. Treatment medications (dates unspecified) included: aluminium hydroxide gel, dried/magnesium hydroxide/simeticone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue, lots of nausea, loss of sense of taste, and chills, and the outcome of no energy to do anything was not reported. This report was non-serious.
severe soreness @ inj site w/in 1st 6-8hr;severe swelling lt upper arm, pain @ site w/in 48hr;unable to lift lt arm;swelling increased;w/in 1 wk could not lift lt arm, became frozen shoulder; now in P.T., still w/pain, prognosis fair
Pt had rxn where she had trouble breathing. Was in hospital x 3 days. Provider thinks it was due to vaccine.
42 yo female reporting moderate GI symptoms and increased fatigue since receiving second Pfizer vaccine on 3/30/2021.  Denies reaction to initial dose of vaccine.  History of IBS diarrhea-predominant as well as chronic fatigue that has been exacerbated.  Reports 3-4 loose stools daily.  Nausea has resolved; no vomiting.  Decreased appetite.  No fevers, chills, cough, respiratory symptoms.   Patient expressing concern for wellbeing and delayed recovery, although she does report mild improvement in symptoms over the past few days.  Discussed case with (Name) at DOH who will consult with MD.  No other vaccine reactions of this sort have been reported to her knowledge.  Discussed continued appropriate home care and RTC/ED criteria.  Patient stated understanding.  If no improvement or worsening over the next week, patient to contact clinic.  Patient to sign up with CDC to report symptoms and will complete ordered labwork when able.  Consider Covid-19 testing if symptoms persist, although patient lives alone and works from home so the risk of exposure is low and symptoms are inconsistent with infection.
Sustained ventricular heart arrhythmia; bigeminy of PVCs; shortness of breath with mild exertion; palpitations; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 19:15 (Lot number: 301U58A) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (received within 2 weeks of vaccination) included: MYRBETRIQ; OMEPRAZOLE; AMBIEN; ALLEGRA; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Erythromycin, reaction(s): "known allergies: erythromycin". The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The following information was reported: VENTRICULAR ARRHYTHMIA (medically significant) with onset 08Oct2021 13:00, outcome "not recovered", described as "Sustained ventricular heart arrhythmia"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "bigeminy of PVCs"; DYSPNOEA EXERTIONAL (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "shortness of breath with mild exertion"; PALPITATIONS (non-serious) with onset 08Oct2021 13:00, outcome "not recovered", described as "palpitations". The events "sustained ventricular heart arrhythmia", "bigeminy of pvcs", "shortness of breath with mild exertion" and "palpitations" were evaluated at the physician office visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Oct2021) negative. Therapeutic measures were taken as a result of ventricular arrhythmia, ventricular extrasystoles, dyspnoea exertional, palpitations. Clinical course: Within less than 48 hours of receiving the vaccine, the patient has developed a sustained ventricular heart arrhythmia where the patient is experiencing bigeminy of PVCs, palpitations and shortness of breath with mild exertion. The patient is seeing a cardiologist now.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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.
vomiting; Kidney stone; Headache; Fever; not to feel comfortable; Didn't feel well; This is a spontaneous report from a contactable consumer (patient's wife). A 61-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0165), via an unspecified route of administration, administered in arm on 02May2021 17:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. No prior vaccinations (within 4 weeks) and no AE following prior vaccinations. Medical history included 6 surgeries on legs, and broke his legs from 2019 (fully recovered and did not take medication at all). Concomitant medication was reported as none. The patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0162) on 14Apr2021 around 16:00 (at the age of 61-year-old) for COVID-19 Immunization. Patient experienced vomiting on 13May2021 and was rushed to the hospital (in May2021) and diagnosed with a kidney stone on 14May2021. Also, reporter stated that after the 2nd shot her husband (patient) didn't feel well in May2021. Stated that a week after the 2nd vaccine she thought he was dying and he was vomiting and was rushed to the hospital and was diagnosed with a kidney stone. Reporter stated she didn't know if it was related but it had to be. Stated reporter tried to contact the insurance company and the hospital and they denied it and she said it could be possibly related to the vaccine. Patient didn't feel well just after 2 days, he had a headache, fever for 2 days (in May2021) and then started not to feel comfortable (in May2021) and couldn't go to work and was vomiting the night of 13May2021 to the early morning of 14May2021. Reporter stated it scared her she thought he was dying. Stated it was confirmed he had a kidney stone and was nothing dangerous and they gave him medication and said it was 3mm and will come out naturally, and it did come out naturally. All AEs required a visit to emergency room (patient never went to the doctor, they were scared of bills so huge from just the ER). The outcome of the events headache and fever was recovered in May2021, of other events was unknown.  Follow-up attempts are completed. No further information is expected.
pain  on left side underarm and breast and under breast and under left scapula.  Started 2 days post  vax  and  still continuing to this day.   no treatment  .
The next day I developed what I thought was a cold sore around the top part of the right side of my lip, then 3 days after that I had a mild shingles outbreak on the right side of my face.,
Information has been received from a registered nurse, concerning a female patient who was vaccinated with the third dose of Gardasil (date unspecified). There was no concomitant medication. The patient developed "little bumps" that developed about 2 days after the vaccination, "mostly near the arm and neck." The nurse reported the bumps did not appear to be hives, but that some of the bumps "appeared to be vesicles." The nurse stated that the vesicles resolved "several days later." The patient sought unspecified medical attention. Additional information has been requested.
Client approached EMT station  complaining  that her "blood pressure felt high." Client was alert and tracking and appeared mildly anxious. Client had a chief complaint of anxiety. Client stated that she was reluctant to receive her second dose of  Pfizer  and stated that now she felt anxious after waiting several minutes in the observation area. Client stated that she experienced vomiting and other mild side effects after her first COVID vaccine dose but was approved for her second Pfizer COVID vaccine dose by medical team. Client denied allergies or medical history. Assessment revealed no swelling, discoloration, hives, shortness of breath or other signs of anaphylaxis. Client stated that she felt lightheaded and denied having breakfast this morning. Airway, breathing and circulation were intact. Vital signs 1155-BP 128/98 heart rate 68 respirations 18, 02 sat-100% room air. Client was alert and oriented to person, place, time and event. Client agreed to stay an additional 30 minutes and was provided with water while she waited.  Client refused any food. Client's vitals were reassessed 15 minutes later. 1210- BP 120/82 HR 79 Resp. 18 and O2 sat 98% on room air. Client refused to stay her remaining 15 minutes and stated that she felt "better? and that she wanted to "go home and eat." She refused to stay for the remainder of the 30mins. Client departed vaccination site with  a steady gait.
Little fatigued; Slight chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little fatigued) and CHILLS (Slight chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Little fatigued) and CHILLS (Slight chills). At the time of the report, FATIGUE (Little fatigued) and CHILLS (Slight chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On 2/12/2022 (4 days after vaccination), patient went to the ER due to difficulty breathing, where he was admitted for health failure.  He was admitted for 1 week, then discharged home.
21 YOM presented to the ED on 1/2  with chest pain and shortness of breath about 2 days after his second Pfizer COVID vaccine. Troponin elevated at 7153 on admission with no changes on EKG. Cardiology suspects that patient has myocarditis. A cardiac MRI is being obtained tomorrow (1/4) to get a closer look at the heart.
weak; Headache; Moaning from Achiness; Pyrexia; Didn't feel good; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of   in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included ATORVASTATIN, PRAMIPEXOLE and TRAZODONE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. Unknown          The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Mom states first noticed redness, soreness & warmth to touch when undressing child on lt upper arm about size of 50cents piece in size;
This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
I had developed two small red bumps all over my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes type 1; "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure; "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma. Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus. The following information was reported: RASH PAPULAR (non-serious) with onset 2021, outcome "unknown", described as "I had developed two small red bumps all over my body".  Additional information: The patient stated About 2 weeks ago I got the first dose of the Pfizer vaccine and probably about 2 weeks later I had developed two small red bumps all over my body. Vaccine name: Pfizer Covid 19 vaccine. LOT# and expiration Date: Patient stated I am not sure what the 5th letter is its going to either be an E or S, let me get my glassed hold on. I think its an E, I am not sure what the first letter is and the second one looks like R873F its not a 7, so then last one will be number 7. NDC UPC & expiration date of Vaccine: Patient stated If that be on my card, I don't know. Treatment: Patient stated I recently got a cream tube it is Triamcinolone. Concomitant Products: Patient stated Sorry do not remember the name for blood pressure medicine. I am on Inhaler for Asthma. Other product: yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt states started itching and swelling aftrer receiving Shot on Friday. By Saturday night noticed Red swollen and warm also painful to touch to right arm.  Going to allergist next week can't take Benadryl.
1/18/05 redness, swelling. 9cm x 11cm, 01/19/05 arm more involved, increased to 17cmx19cm red, warm to touch, swollen. Non painful to touch. Given Augmentin 400mg PO bid x10 days. To call if becomes worse.
1 week after receiving the shot, the area began to swell, got really hot, itchy, bumps in the area and I felt really tired.
unusual changes in color vision, upon exam found narrowing of the ocular arteries. Medical history does not show anything?ll that could explain the reasons behind the development of these symptoms.
PARENT PROVIDED WRONG BIRTH YEAR SO THAT CHILD COULD RECEIVE COVID SHOT. NO ADVERSE EVENTS REPORTED.
brain fog; Ongoing low grade fever; Fatigue; nausea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EQ0150) via an unspecified route of administration in the left arm on 05Apr2021 at 11:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included borderline personality disorder, kidney stones, latex allergy, adhesives allergy. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), lamotrigine (LAMICTAL), trazodone hydrochloride (OLEPTRO), famotidine (PEPCID), paracetamol (TYLENOL) all from an unknown date for an unspecified indication. The patient previously took fentanyl (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 06:30, the patient experienced ongoing low-grade fever, brain fog, fatigue, nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events ongoing low-grade fever, brain fog, fatigue, nausea was not recovered.  No follow-up attempts are needed. No further information is expected.
heart palpitations chest pain, BP 187/95 pulse 106 reported to emergency room
Getting Urticaria all over body on arms, legs, body, neck etc. Started happening from around 4/7 every 2-3 days and still having the same every day now.  It originally started with rashes all over body which used to appear every few days in the evening. Started administering a combination tablet of montelukast and levocetirizine every time it occurred based on recommendation from a doctor. Had dismissed at as an allergical reaction to some food or insects etc. but when it continued occurring, visited a dermatologist on 4/18 who diagnosed it as urticaria, which is probably a side-effect of the vaccine since I am not taking any medication or allergic to any foods, nuts etc.   Dermatalogist recommended starting a course of fexofenadine 180 mg and taking it daily for the next 30 days. Since starting on 4/18, have observed rashes every single evening around 6 - 9 pm, which tend to disappear a few hours after taking the tablet.
local redness, soreness, swelling, warmth inside the body, diarrhea.
Patient went to hospital with chest pain on 3/17 and was found to have a pulmonary embolus. Started on anticoagulant. Had full workup
Peripheral neuropathy - began Sept. 30 - increased - tingling - pins: needles - hands: feet - Oct. 3 - continue to spread - various nerves in body blink on and off - hands and feet - burning sensation. Oct 4 beginning to subside.
all over sore/like all over my body; my lower back pain; my leg, my thigh pain; muscle pain; my arm pain; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), dose 1 intramuscular, administered in Arm Right on 12Feb2021 17:00 (age at vaccination 74-year-old) as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were none. On an unspecified date, the patient experienced all over sore, her arm, her lower back, her leg, her thigh pain, like all over her body and muscle pain and ache in back. The patient was tried exercising and it does not go away. This was patient first dose and she was getting her second dose on Friday (unspecified date). The patient assessed the events as non-serious. No adverse event following prior vaccinations. The outcome of the events was not recovered.  No follow up attempts are needed. No further information is expected.
Received vaccine on 12/29/2022, reports weakness, chest pain and left arm pain when coughing on 1/7/2023, she was diagnosed with bronchitis and influenza-like illness on 1/10/2023, but Influenza A&B were negative and rapid COVID was negative on this date.  She was prescribed a Z-pak on 1/10/2023.  On 1/17/23, she still complained of cough and weakness and was seen by her PCP.  A chest Xray and CBC was ordered on this date.  Chest Xray (1/20/23) showed cardiomegaly and CBC (1/20/23) showed pancytopenia which is a known chronic condition for this patient.  She started experiencing chest pain, weakness, right arm pain on 1/27/2023 and went to the ER.  Patient was admitted to hospital on 1/27/2023.  Echocardiogram on 1/28/2023 shows moderate pericardial effusion.  Patient was started on prednisone and colchicine.  She is still hospitalized at time of this submission.
arm soreness; bad nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and NAUSEA (bad nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and NAUSEA (bad nausea). On 15-Mar-2021, NAUSEA (bad nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No medical history was provided by the reporter.  Treatment medications were included supplements for an unknown indication.   This case was linked to MOD-2021-407147, MOD-2021-407149 (Patient Link).