chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive for SARS COVID 2; Positive for SARS COVID 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL1283), on 06Feb2021 as dose 2, single (Lot number: EN5318), on 04Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 27May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 80 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive for SARS COVID 2". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive for SARS COVID 2; Weight: 185-190, notes: Weight: 185-190. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Reporter stated that she was listening to an online channel talking about the immunization is not for b4 and b5 and she got the last booster 22May not even 6 months so it indicates the past boosters there are break through cases.
Moderna vaccine given 3/15/21,4/12/21 Pfizer given 6/1/21
Severe local reaction at site of injection. PNEUMOVAX 23 0.5 mL given IM RA deltoid. Large welt reaction approx. hand-size observed appearing within hrs of injection. Resolved within 48 hours as per patient.
cough; body ache; fever; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COUGH (cough), PAIN (body ache), PYREXIA (fever) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19 in April 2021.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (body ache), PYREXIA (fever) and HEADACHE (headache). On 12-Apr-2021, the patient experienced COUGH (cough). At the time of the report, PAIN IN EXTREMITY (sore arm), COUGH (cough), PAIN (body ache), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            On unknown date, Covid test was performed on patient with negative results.  No relevant concomitant medications were reported.  Treatment information was not provided.
Information has been received from a registered nurse concerning a female (age unknown) with a history of bronchitis and allergies to erythromycin and LORTAB, who, on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 25-FEB-2008, the patient was vaccinated intradermally with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 659147/1381U). On 25-FEB-2008, the patient developed redness, warmth and pain at the injection site. The patient was seen at an office visit. No laboratory diagnostics were performed. At the time of the report the patient had not recovered. No product quality complaint was involved. Additional information is not available.
Headache 48 hours after shot; Fever for 36 hours; Body aches for 24 hours; Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there; Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there; Thirsty; Dose received: 3; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 at 12:00 (Lot number: unknown) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: other medical history: no; known allergies: no. Concomitant medication(s) included: BOVINE COLOSTRUM; BRYONIA and ZEEL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6206; Anatomical site: left arm: Administration time: 11:00), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8733; Anatomical site: left arm; Administration time: 11:00), administration date: 30Mar2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 12:00, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 01Dec2021 at 20:00, outcome "recovered" (03Dec2021 at 08:00), described as "Fever for 36 hours"; PAIN (non-serious) with onset 01Dec2021 at 20:00, outcome "recovered" (02Dec2021 at 20:00), described as "Body aches for 24 hours"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), all with onset 01Dec2021 at 20:00, outcome "recovering", all described as "Lymph node in arm pit on left arm is sore and swollen for 48 hours. Has lessened over time but is still there"; THIRST (non-serious) with onset 01Dec2021 at 20:00, outcome "recovering", described as "Thirsty"; HEADACHE (non-serious) with onset 03Dec2021 at 12:00, outcome "recovering", described as "Headache 48 hours after shot". Therapeutic measures were not taken as a result of pyrexia, pain, lymphadenopathy, lymph node pain, thirst and headache.  Additional Information: 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 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician concerning a 12 months old male baby with CHARGE syndrome who on 26-JAN-2012 was vaccinated with a dose of MMR II (dose and route not provided) (lot # 662352/1249X, expiration date on 05-SEP-2010) and a dose of VARIVAX (Merck) (dose and route not provided) (lot # 0509X, expiration date in March 2010). Concomitant therapy included erythromycin. On 31-JAN-2009, the patient developed vomiting following administration of MMR II and VARIVAX (Merck). On an unknown date, the patient was hospitalized for dehydration related to vomiting and was diagnosed with "significant" hepatitis. On 04-FEB-2009, the patient's aspartate aminotransferase (AST) was 629 and alanine aminotransferase (ALT) 1078, that normalized over next two or three weeks. On an unknown date, the patient's liver function tests and hepatitis viral panel were normal. The physician reported that the patient was "ultimately" fine. The relatedness for significant hepatitis was unknown for MMR II and VARIVAX (Merck). Additional information has been requested.
Father stated that 12hrs after vaccines given child's hands where swollen, dry and redden encircling wrists. "It looks like a sunburn." C/O itchiness. No fever or other rashes. Instructed to seek medical care.
Weakness, fatigue, shortness of breath, chest pains, swollen lower legs, increased appetite, sticky skin, tight feeling in chest, irregular heart beats
51yo Male, received 2nd COVID pfizer vaccination 6/17, since then has had chills, fatigue, DOE, headaches, body aches, dry cough, random easy bruising. Had been ruled out for ACS 6/18 in ED, CXR neg. Many of symptoms typical post-vaccination symptoms, but cough/DOE atypical. Patient also tested neg for COVID 6/22/21. Afebrile (fevers only lasted first 2 days after vaccination). 1 month later, symptoms are unchanged. I am repeating a D-dimer, CXR, CBC, INR. Patient has been unable to keep his job due to his ongoing symptoms. Patient has been very worried about symptoms, likely strong anxiety component contributing as well, but etiology of symptoms still unclear.  consulted ID, recommended further labs. Repeat CXR 7/26 clear, repeat D-dimer neg.
Suffered an allergic reaction from first dose; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number was not reported)), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient suffered an allergic reaction from first dose from Pfizer Covid-19 vaccine on an unspecified date. She wanted to ask I have been advised not to take the second dose, so my question is, what protection do I have since I only had one dose of the vaccine. The outcome of unknown event was unknown.   Follow-up (04Mar2021): She wants to know how much protection she has with only just 1 dose of the vaccine. I offered to warm transfer the consumer to DSU, but she declined. DSU: E transmitting due to AE.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
syncopal episode; dry mouth; chills; nausea; This is a spontaneous report from a non-contactable other health professional (patient). A 20-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 12Jan2021 12:00 (Batch/Lot number was not reported), second dose on 02Feb2021 14:30 (Batch/Lot number was not reported), both via an unspecified route of administration administered in left arm, at 20-year-old female (not pregnant at the time of vaccination) at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient experienced dry mouth, syncopal episode, chills, nausea on an unspecified date. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on an unspecified date. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes 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 RAs, Ethics Committees, and Investigators, as appropriate
Patient began having breathing issues 3 days after the vaccine.  Was admitted to the hospital and received breathing treatments and steroids.  Full recovery occurred.  The patient reports that the connection to the flu shot was questionable, according to the doctor.
Sore lymph nodes in both armpits. Started in the left armpit on 3/8. Progressed to right armpit by 3/10. Soreness is mild, and is not always noticeable. Soreness has persisted, and remains as of today (5/14). Right armpit is more sore than the left. Lymph nodes do not feel very "swollen," but are sore to the touch in both armpits.
Full body rash Tylenol given as needed Fever 102 degrees F Diarrhea 11-12 days after vaccinations
The day after 1st GARDASIL given mother noticed a dime size red spot that steadily increased in size and warmth. Seen in office on day 8 and TX with AUGMENTIN for cellulitis. Returned day 11 with increased pain. Cellulitis improved but increased pain. US of area -> swelling no focal collection of fluids. Severe Pain lasted approximately 12 d.
PATIENT DID NOT DISCLOSE A SPECIFIC TIME OF ONSET.  PATIENT REPORTS THAT EXISTING MIGRAINES HAVE GOTTEN WORSE AND SHE IS NOW EXPERIENCING MENSTRUAL IRREGULARITIES.
Pt admitted from ED with a past medical history of active metastatic breast cancer, generalized weakness, difficulty breathing, and a nonproductive cough.  She was transferred to another hospital due to management of pneumonia due to COVID-19 virus.
linear papular rash on the right arm and slightly itchy; linear papular rash on the right arm and slightly itchy; Swelling of the entire left arm; erythematous this occured about 8 hours after the 1st dose; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received first dose of BNT162b2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration administered in the left arm on 03Jun2021 as dose 1, single for covid-19 immunization. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. On 04Jun2021, about 8 hours after the 1st dose, the patient experienced swelling of the entire left arm and erythematous in left arm. On 05Jun2021, about 24 hours after vaccination, the patient experienced linear papular rash on the right arm and slightly itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of all the events was not resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
extreme dizziness after 6 hours and still have it; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8727) via unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 42-years-old) as a single dose for Covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 17:00, 6 hours after vaccination, patient experienced extreme dizziness and still had it. The patient received dizziness pills for the adverse event. The event resulted in emergency room/department or urgent care visit. The clinical outcome of the event dizziness was not resolved at the time of reporting.   No follow-up attempts are needed. No further information expected.
Pt began having seizures 1 week after 6 month vax. The condition worsened about 4 months later (increased frequency of seizures and pt was hospitalized). Pt was stable on medication and then had vax on 8/31/01 and began having uncontrollable seizures and right sided weakness.
Mild postprandial nausea that resolved after rest, moderate fatigue that lingered for 3-4 hours that started at 10am, Fever of 99.5F that started around 1:30pm
Fever; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (Wife) of unspecified age that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 08Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on unspecified date for COVID-19 immunization. On 09Apr2021, the patient experienced fever. Patient got her second shot (Pfizer, Covid-19 vaccine) yesterday and this morning she got fever, the consumer wanted to know does patient need to take Aspirin for this situation or not. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tinnitus, chest pressure, high heart rate. All happened within 24 hours of the last shot.
This Shingrix vaccination was administered by my technician that is a certified immunizer. However, at pharmacy, such technicians are only allowed to administer Covid-19 vaccines at this time.
7-27-09 1:00 PM Mom called to report daughter's (R) arm was red, swollen and real sore. She also couldn't pick up her arm very high. Mom called back at 4: 00 PM. Her (R) arm was hot to touch and her (R) arm from elbow to hands were turning purplish blue - went to ER.
Seizures, high fever of 105.6, extreme vomiting, high heart rate .   * before vaccine on 8/8/22 his asthma was getting betttsince he?s needing more breathing treatments as of now 9/2/2022
Diagnosed with DVT; Leg got really swollen/swelling of the lower calf area; Sore arm; Sore arm; Pulled a muscle; A spontaneous report was received from a consumer concerning a 57-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, DVT/ deep vein thrombosis, pulled a muscle/myalgia, swelling of the lower calf area(leg got really swollen)/peripheral swelling and calf pain(sore arm)/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 FEB 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Jan 2021, after receiving the vaccine the patient had sore arm. On an unspecified date in Jan 2021, the patient had experienced a pull in his muscle in his calf and lower calf area got swollen. On 09 Feb 2021, after receiving the second dose of vaccine he had experienced a sore arm. On 11 Mar 2021, his leg got really swollen and on 12 Mar 2021, he visited hospital where it got diagnosed as DVT in his right lower calf. Treatment for the events included blood thinner Apixaban. Patient is concerned about possibility of indirect relation of events to the vaccine.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The outcome of the event DVT, leg got really swollen, swelling of the lower calf area and calf pain were unknown at the time of this report. The event pulled a muscle is not resolved. The event sore arm which the patient experienced for both the doses got resolved on 13 Jan and 14 Jan 2021, respectively.; Reporter's Comments: Based on the information provided which includes a strong temporal association a causal association between the event of sore arm and the administration of mRNA-1273 cannot be excluded.  The evens of DVT , pulled muscle and swelling of lower calf is assessed as unlikely related to mRNA-1273. Events were all attributed to muscle strain.
Sick; High fever; Chills; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received Shingrix. In April 2021, less than 2 weeks after receiving Shingrix, the patient experienced sickness, fever and chills. On an unknown date, the outcome of the sickness, fever and chills were unknown.   It was unknown if the reporter considered the sickness, fever and chills to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination not reported. The patient had a shingrix vaccine and was sick. The patient had high fever and chills. The patient's healthcare professional told patient to wait for a week after administration of shingrix vaccine to receive Xeljanz. The patient asked if she has to get booster in a year with pfizer covid vaccine whether she need to stop her xeljanz. No other information was reported. The follow-up would not possible, as no contact details were available.
The day of the vaccine I started wheezing having trouble breathing, tightness in chest. The next I broke out in hives all over my body. They gave me a steroid shot and Benadryl and a prescription to take.
Information has been received from a MA concerning an 82 year old female with hypertension who on 04/22/2003 at 1:30PM was vaccinated IM with a second 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M - multidose vial).  Concomitant therapy included levothyroxine Na (SYNTHROID).  On 04/23/2003 at 12 noon the patient developed swelling, redness and induration from the injection site down to the elbow.  It was noted that the patient recovered.  No relevant diagnostic tests or laboratory data were reported.  There was no product quality complaint.  Unspecified medical attention was sought.  The reporter also indicated that two other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed swelling, redness, and induration from the injection site down to the elbow (WAES # 0305USA02389 & 0305USA02391).  No further information is expected.
Pt recvd 3 doses of Engerix-B & did not seroconvert; booster doses were administered;
Diarrhea, upset stomach, crying (not usual for this baby at all). Basically out of it and not interested in nursing, fussy. Next morning on Nov 10, baby was pale almost ashen and weak, not interested in nursing at all, overly tired and cranky, fussy, crying which is unusual for him. Not alert, eyes glazed over and staring into space. Then he went limp and lethargic with eyes open, but was not responding. Brought him to hospital immediately. The days prior to this he was also very sleepy and cranky but it escalated from nov 6 when he received the vaccinations to nov 9/10 2012. Perfectly healthy alert and bright baby boy. Had a major adverse reaction to the DTaP. Will not be vaccinating again. He was in ICU for 4 days because of this.
This spontaneous report was receive from the registered nurse and refers to a patient of unknown age and gender. On 04-DEC-2014, the patient was given oral, ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. on 27-OCT-2015, the patient was vaccinated with a dose of an improperly stored MMR II (lot # L010488 with an expiration date on 26-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.