chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle ache at injection sight; Muscle ache at injection sight; Fatigue; Short term chills; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the left arm on 03Nov2021 at 09:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications within two weeks of vaccination which were not specified, for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 11:15 (at the age of 65-years-old) as single dose for COVID-19 immunisation and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 17Apr2021 at 10:00 (at the age of 65-years-old) as single dose for COVID-19 immunisation. On 03Nov2021 at 22:00, the patient experienced muscle ache at injection site, fatigue and short term chills. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle ache at injection site, fatigue and short term chills was resolving at the time of this report.
"My" first menstruation cycle that occurred following the 2 week requirement to be considered fully vaccinated began almost 2 weeks early / "My" period is always on time, never early; This is the first time "I" have had a period last >7 days/ or have had non stop bleeding; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 20Sep2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. 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 vaccination. Concomitant medications included esomeprazole sodium (NEXIUM), over the counter (OTC), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 30Aug2021 at 13:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 21Oct2021 at 12:00, the patient experienced her first menstruation cycle that began almost 2 weeks early following the 2-week requirement for being considered fully vaccinated; her period was always on time, never early, not once in her life, but her menstruation had not stopped ever since; some days were lighter than others, but some had required a tampon. This was the first time she had a period that lasted more than 7 days, or had non-stop bleeding. The patient felt it was very disturbing since this possibility was "NEVER" explained to her. She would have opted out if she had known. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events first menstruation cycle that began almost 2 weeks early following the 2-week requirement for being considered fully vaccinated; her period was always on time, never early, period that lasted more than 7 days, or had non-stop bleeding was not resolved at the time of this report.
superficial complete layer of skin peeled off both palms of hands and soles of feet over a week time period. Similar to blistered skin would peel off.
Cough; Adverse drug reaction; Fatigue extreme; Depression; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depression), COUGH (Cough), ADVERSE DRUG REACTION (Adverse drug reaction) and FATIGUE (Fatigue extreme) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On 16-May-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 UNK. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced DEPRESSION (Depression), ADVERSE DRUG REACTION (Adverse drug reaction) and FATIGUE (Fatigue extreme). On an unknown date, the patient experienced COUGH (Cough). At the time of the report, DEPRESSION (Depression), COUGH (Cough) and FATIGUE (Fatigue extreme) outcome was unknown and ADVERSE DRUG REACTION (Adverse drug reaction) had not resolved.            No concomitant medications were reported.  On an unknown date, the patient experienced cough. in May 2022, the patient experienced adverse effect of skyrizi, severe fatigue and depression. Moderna covid-19 vaccine was also considered suspect.   The patient had been experiencing severe fatigue and depression in the May 2022 after her initial dose of skyrizi on 16 May 2022. she had cough.   The reporter causality for the event (s) of adverse effect of skyrizi, severe fatigue, depression and cough was not provided.   It was unknown if patient was enrolled in any Covid-19 vaccine trial.  No treatment medications were reported.
HEART PALPITATION; BODY ACHES; CHILLS; HEADACHE; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included digestive problem, anxiety, penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced chest tightness. On 18-MAR-2021 18:00, the subject experienced body aches. On 18-MAR-2021 18:00, the subject experienced chills. On 18-MAR-2021 18:00, the subject experienced headache. On 20-MAR-2021, the subject experienced heart palpitation. Laboratory data (dates unspecified) included: EKG (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and the outcome of headache, chills, chest tightness and heart palpitation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 20th January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 23-Jan-2023. Reporter's Comment: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received expired Havrix vaccine, which led to expired vaccine used. The case is linked with case US2023009572, reported by same reporter.; Sender's Comments:  US-GSK-US2023009572:same reporter - husband´s case
On the evening of October 19, 2021 at about 11:45pm, I felt my heart start to beat rapidly. At that time I believed it was because I was over tired so I went to bed. On the next morning about 7:30am I woke up and took my blood pressure and heart rate and my pressure was 82/55 and my heart rate was about 150. I called my family doctor and related the information to the nurse and they told me to go to the doctor's office - I went in about 1pm that afternoon. They did EKG and determined I was in A-Fib. Heart rate was 157. They called cardiologist team for instructions. I went back home after the visit. I drove into driveway they called and said go straight to ER.  I went to ER and while in waiting room I passed out while in wheel chair.  They took me into observation room and I "came to".  They wanted to keep me overnight for observation, the 20th. Had an Echocardiogram and it was normal. Confirmed A-Fib and ordered blood thinners - Eliquis. Released from hospital on October 21, 2021. I have not had A-fib since that day.
The morning before I tested positive for COVID-19. I have a low grade fever, sore throat, burning in nose, terrible congestion, and body aches. I called my doctors office and they prescribed me Paxlovid. I am just now finishing it and I feel a little better. I still have body aches and a little throat issues and fatigue.
pt cried & was irritable for approx 5 hrs p/vax administered; tx consisted of APAP;
Pt called asking about thimerosal in shingrix because she thinks she might have been allergic the the vaccine.  After review the data, and inform that patient that there is no thimerosal in the shingrix vaccine.  Upon discussing with regarding the reaction.  She stated that she had gotten a shingrix vaccination on 10/07/22 and the following day; she had a body rash across the chest, sore throat that feels a little swollen and fatigue but no reaction at injection site.  She stated that, she had taken some antihistamine and tylenol and has since feel mostly normal now (today).  She has not seek medical care and doesn't think she needs it since she has improved drastically.   She is unsure if its something she ate or the vaccine.  I am also unsure.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site lump and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site lump and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not provided but was captured adult as per vaccine indication. The pharmacist stated that she has had several patients who reported that after receiving the SHINGRIX vaccine, they experienced warmness, redness, and a knot at the injection site. The pharmacist did not have any additional or specific details regarding these patients. This case is 1 of the 3 linked cases reported by same reporter.
Initially fever, tiredness, headaches, muscle aches which last approximately 2-3 days.  After i had pretty much recovered from above I developed a rash lasting approximately 24 hours.  2-3 days after the vaccine developed severe pain and swelling under arms which lasted approximately 1 week but still reoccurs from time to time.  Additionally 4 days after I was vaccinated we learned my minor son tested positive with no know exposures to Covid
Aortic rupture; This spontaneous case was reported by a consumer and describes the occurrence of AORTIC RUPTURE (Aortic rupture) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced AORTIC RUPTURE (Aortic rupture) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 21 days due to AORTIC RUPTURE. The patient was treated with Surgery for Aortic rupture. At the time of the report, AORTIC RUPTURE (Aortic rupture) was resolving.            No concomitant medication provided. No treatment information mentioned.  The patient was in the hospital for 3 weeks, had surgery due to tear in aorta. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Reporters causality for events with HUMIRA was not provided, but sender is of opinion there is no reasonable possibility of relation.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case concerning a 59-year-old female patient with medical history of plaque psoriasis, who experienced the serious unexpected event aortic rupture, on an unknown date after the second dose of mRNA-1273.  The patient was hospitalized for three weeks and had surgery due to tear in aorta. Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 59-year-old female patient with medical history of plaque psoriasis, who experienced the serious unexpected event aortic rupture, on an unknown date after the second dose of mRNA-1273.  The patient was hospitalized for three weeks and had surgery due to tear in aorta. Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
blurry vision,headaches,lack of sleep,pain in joints,lower back pain,itchy skin,dry throat,memory loss.low sperm count.
Received Dtap and Varicella in Left deltoid on 6/27/2012. Presented to ER on 6/29/2012 with redness, swelling and tenderness in left arm. Diagnosed with cellulitis secondary to receiving vaccinations.  Gave Keflex.  Returned to health department for health check on 7/6/2012 and stated had gone to ER for above problem. Records requested from ER and report made.  No further problems noted.
Also, I had a second Pfizer COVID 19 shot on 1/19/2021. I had oral surgery on 1/8/2021 required an 8 day course of antibiotics. Adverse event began 1/15/2021, with migraines lasting 24 hour/day X 3 weeks, tingling in face, arms, legs, feet. Migraines resolved.  Tingling, numbness continued. ON June 25, 2021, 7-8 lesions found in my brain indicating possible demyelination. I see a neurologist on July 28, 2021. I have not yet been diagnosed. Prior to 12/29/2020, prior to first Pfizer shot, I had hypothyroidism and osteoporosis. No other chronic conditions.
She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
erythema, swelling and warmth at injection site in less than 8 hours, pain in left thigh where only varicella vax was given.
SENSATION OF BURNING OF TONGUE, LIPDS, THROAT AND NOSE WITH PAIN.  EXAM FAIRLY BENIGN, NO OBVIOUS ABNORMALITIES OTHER THAN MILD GLOSSITIS.  TREATED WITH ANTIFUNGAL AND ANALGESICS
Patient had 2 doses of Pfizer as her first 2 doses, received Pfizer on the 1st boaster dose, however received Moderna on the 2nd boaster. arm was sour few hours after the vaccine. She stated that she applied some ice pack before bedtime. Arm turn purple, swollen, painful and big blister the following morning. No difficulty breathing, no obstruction. She went to the clinic and was given some ointments to apply and was advised not to pill the blister. patient is on prednisone daily.  Patient stated the arm is better than before.
(Size of adult palm) Red mark, hard, heat radiating from the area, sore to touch (within 36 hours of shots).
Information has been received from a 64 year old female with no known drug allergies and no pertinent medical history who on 18-JAN-2011 was vaccinated with ZOSTAVAX (Merck) (route, dose and lot# unspecified). There was no concomitant medication. On 30-JAN-2011 the patient stated that she started feeling tingling on her lip which developed to a sore. The consumer mentioned she would be seeking the advice of a health care professional. The patient had sought unspecified medical attention. There was no any lab or diagnostic test performed. At the time of the report, the outcome was unknown. Additional information has been requested.
Patient received Moderna vaccine before 18th birthday..  turns 18 in 7 days
Pt experiencing erythema, warmth, and tenderness at injection site - R arm where varicella vaccination given. Sx x 3days not improving.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 20-APR-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB, lot number K026531 with expiration date 15-APR-2017, (dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Severe fatigue; chills; headache; sore throat; muscle aches; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number not provided), via an unspecified route of administration in left arm on 23Dec2020 16:45 at single dose for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient experienced severe fatigue, chills, headache, sore throat, muscle aches on 24Dec2020. Case was non-serious. The patient underwent lab tests and procedures which included covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=26Dec2020, covid test result=Negative. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Severe headache, arm tenderness, hardened area at the injection site, warm to touch, and fatigue all occurred the same day.  Body aches occurred the next day.  Headaches continue on and off but not as severe.  Energy is slightly improved
they were to get PENTACEL and they gave the DTaP-IPV portion but not the ACTHIB with no reported AE; they were to get PENTACEL and they gave the DTaP-IPV portion but not the ACTHIB with no reported AE; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 months old female patient was to get pentacel and they gave the dtap-ipv portion but not the acthib with no reported adverse event(ae), while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 10-Aug-2022, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at an unknown dose once (lot number, expiry date: not reported) via unknown route at an unknown administration site.  On 10-Aug-2022 the patient was to get pentacel and they gave the dtap-ipv portion but not the acthib with no reported ae (single component of a two-component product administered) (product preparation error) same day latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Legs became very red. Cold compresses given in office. 435pm Dad said legs still a little red, but seemed fine.