chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 46-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Reporter stated that no adverse reactions were reported by any patients.
Information has been received from a nurse practitioner concerning a 13 year old female who on 26-MAR-2007 was vaccinated with Gardasil. On 26-MAR-2007 the patient developed swelling of the arm, arm and chest pain, nausea, vomiting, facial swelling and difficulty breathing. The patient went to the emergency room and was treated with Phenergan. Subsequently, the patient recovered. The nurse practitioner reported that she never saw this type of reaction before and that the patient never reacted to any other vaccine. The reporter felt that the swelling of the arm, arm and chest pain, nausea, vomiting, facial swelling and difficulty breathing were other important medial events. Additional information has been requested.
suffered a massive heart attack; Feeling of faintness; Palpitations; Shortness of Breath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (suffered a massive heart attack), SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Feeling of faintness) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant) and DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant). On 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (suffered a massive heart attack) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was suffered a massive heart attack. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) outcome was unknown.            No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 was not applicable.  A Patient called to report that two weeks after the first dose of the Moderna Covid-19 vaccine on 27-May-2021, his boyfriend began to experience palpitations, shortness of breath and feeling of faintness. The caller stated that her boyfriend did not want to go to the emergency room and only set an appointment with his Health Care Provider, but on the 09-Jun-2021, the day that he was going to the appointment, he suffered a massive heart attack and passed away.  This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Sender's Comments: This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Reported Cause(s) of Death: suffered a massive heart attack
After 10-15 min, started having chest pains waited 30 ? min, got worse (I had to wait for my ride). Felt like severe indigestion or gallbladder attack which I never had before or since they took back, gave me 2 table spoons MALOX and oxygen, then (left weak kneed had a headache Saturday, slight headache).
High fever (102F), chills, shaking 9-15 hours after vaccination; extreme muscle fatigue and pain (hips, lower back, neck) 6-24 hours after vaccine, mild intermittent nausea about 9-15 hours post-vaccine. Flu-like symptoms (headache, fatigue 4-28 hours after vaccine).
Heard a sound in ear that sounded like a central air conditioner being on. When I left the location the sound persisted. I later realized that the hearing from my right ear changed and when I listen to the phone on right ear then the sound is diminished and the sound when the phone is ringing sounds different from right to left ear.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient called 11/8/2021 to report adverse effects starting in the afternoon on 11/6/2021 after her booster dose.
Narrative:  Patient received one dose of covid vaccine. PMH included ETOH abuse, CVA, afib on xarelto, CAD s/p MI, hyperlipidemia, chronic LE lymphedema, gout, Vit D deficiency, and colonic polyps (patient refuses colonoscopy). No documentation relating to cause of death. Reporting per instruction.
shingles shot / 2nd dose / weak, headache, Nauseated, and a fever of 100; shingles shot / 2nd dose / headache; shingles shot / 2nd dose / Nauseated; shingles shot / 2nd dose / fever of 100; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 16th March 2021, the patient received the 2nd dose of Shingles vaccine. On 17th March 2021, 1 days after receiving Shingles vaccine, the patient experienced weakness, headache, nausea and fever. On an unknown date, the outcome of the weakness, headache, nausea and fever were unknown.   It was unknown if the reporter considered the weakness, headache, nausea and fever to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2nd dose of Shingles vaccine and next day experienced fever of 100 F with weakness, headache, nausea. The follow-up would not possible as no contact details were available. No further information was reported.
Vaccine administered on 5/15/2023; expired date of 5/11/2023
DIARRHEA; FEVER-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced diarrhea, and fever-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever-like symptoms and diarrhea was not reported. This report was non-serious.
The employee was given the flu vaccine at approximately 10:45 and within 15 minutes experienced a rash, tightening of the throat, wheezing and difficulty breathing. The pt was treated with epinephrine and Benadryl. Called 911 for transport to the hospital. After receiving medications, breathing improved. The type of reportable event was anaphylactic reaction.
after a couple of months later i had heart racing randomly and then i went to the doctor because of my high blood pressure and they gave me a medicine. My blood pressure is increased and it's still the same.
Client received two previous doses of Pfizer prior to receiving this Pfizer dose on 07/17. The previous Pfizer dates were 02/03/2021 and 02/24/2021. Client attempted to receive fourth Pfizer dose today (08/07/2021). Client admitted today to receiving the first two doses at another site and attempted to complete a second series under his doctor's recommendation. Client did not receive additional Pfizer dose today. Client attests that he did not have any adverse reaction after receiving his third Pfizer dose.
Cellulitis noted, 3 days, post vax, at injection site of DTAP.  Pt given Keflex
pt recv vax & exp soreness & heat @ the inj site, devel redness @ the inj site & exp muscle aches to a point could not lift arms;
Hives on entire body began to appear approximately 36 hours after vax. and remained for approximately 4 days.  Took Benadryl for 5 days. Last hives resolved 5/18/00. Oral temp. 99.9
Pain at the injection site; Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single and administered in arm right, administration date 18Mar2021 18:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain at the injection site"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DVT in left leg, positive occlusive DVT right femoral vein and popliteal vein
Vaccines DTAP and IPV given on 6/17/14. Pt returned to clinic on 6/19/14 with blanching mottled redness below vaccine site, mildly to mod. swollen from about 4" above kneecap to 1" above knee cap width 2" - painful.
Injection site pain for 72 hours post injection (Dec 30-Jan 2) At injection site a raised red hard swelling 6cm round, very itchy. First noticed Jan 6 and is beginning to recede, but is still present.
Patient presented to emergency department on 1/19/2022 for a fall. He had tested positive for COVID-19 using a home test prior to presentation. Patient was asymptomatic for COVID-19 infection during admission. He was discharged to inpatient rehab facility on 1/25/2022. Patient was readmitted from rehab facility with respiratory failure on 1/26/2022. He was treated with baricitinib and required supplemental oxygen. He was discharged to long-term acute care hospital on 2/15/2022.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-JAN-2014 the patient was vaccinated with an expired dose of M-M-R II (lot # 0012AE, expiration date 16-DEC-2013) 0.5 ml (route, indication not reported). No adverse effects reported. Additional information has been requested.
10-31-09 Patient received H1N1 0.5ml IM RD, without problem. Patient was pregnant. 11-6-09 Patient again came to clinic was given H1N1 .5ml IM RD. Patient was reviewed & answering screening questions, again checked yes that this was her 1st flu shot. 11/18/09 Medical records received for date 11/10/09. OB recs. DX: normal pregnancy, dysuria, UTI,  group B strep carrier. OV 22wks pregnant, Pt. c/o not doing well. c/o yellow discharge w/ itching, pain w/ urination, groin pain, migraines daily. Received H1N1 vax twice. 10/31 and 11/6. Assessment: (+)FM.
Day 1 after vaccine, hard nodule formed at site of injection, nodule resolved then erythema spread over back of arm from axilla to elbow. Pt seen  7/18/07 - tx'd for possible cellulitis w/ Keflex PO and oral Benadryl. Follow-up Information 29-OCT-2007: 8/14/07 - received varicella and Hepatitis A vaccines - site where varicella vaccine was given, localized erythema with firm nodule appeared the next day with erythma firmness, warmth spreading over back of upper arm to elbow - Tx'd for possible cellulitis - Pt did not return for follow-up.
Information was received from a licensed practical nurse referring to a 12 month old male patient. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. On 06-AUG-2018, the patient was vaccinated using public funds at a private doctor's office/hospital with improperly stored vaccines of VARIVAX (lot# R002051 and expiration date unknown) subcutaneously in the left thigh, M-M-R II (lot # N027782, expiry date unknown) subcutaneously in the right thigh, VAQTA (lot # R003739, expiry date unknown) intramuscularly in the left thigh and the fourth dose of PREVNAR 13 (lot # T94425, expiry date unknown) intramuscularly in the right thigh for prophylaxis. No doses of VARIVAX, M-M-R II and VAQTA were administered previously. 3 doses of PREVNAR 13 were administered previously. No prescription treatment was required for the experience. The temperature and time frame the vaccines exposed were unknown. Data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1808USA007644:
After the Patient went home, she saw a rash develop on her arm with the vaccination. It than begin to spread and now she states that it caused some swelling on her tongue. She took 2 Benadryl 25mg tabs that night. 2 days later 12/30/15 she came to the pharmacy to show me the reaction, it has improved but the rash is still there and spreading.
pressure in my chest, heart fluttering/racing, irregular pounding -- soreness around sternum -- I've had this with each shot in the series
immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 12-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised".  Clinical Course: Patient took Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent, Gray cap, Original (Monovalent), greater than or equal to 12 years - 30 mcg/dose, do not dilute. Caller was calling for her daughter 12-year-old in primary series a year ago and now he would like to know which vaccine she should get for the booster dose since she was immunosuppressed. Confirmed above information with caller. Caller was a caregiver that states his 12-year-old daughter was immunocompromised. The caller stated she completed a primary series a year ago and that this primary series consisted of two doses only, not three. Caller requests information on which vaccine should be indicated to her daughter, if the monovalent third primary series or the bivalent booster. Caller was a caregiver that requests the differences between the Pfizer-BioNTech COVID-19 vaccine for 12 years and older (gray cap) and the Pfizer-BioNTech COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster dose for 12 years of age and older (gray cap). Caller was a caregiver that asks whether the Pfizer-BioNTech COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster dose for 12 years of age and older (gray cap) would be more effective than the Pfizer-BioNTech COVID-19 vaccine for 12 years and older (gray cap) in protecting her daughter who was immunocompromised and only received a primary series of two doses instead of three.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
elevated heart rate; brain fog; anxiety; confusion; giddiness; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Right on 28Feb2021 at 12:00 (at the age of 40 year) as dose 1, single for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included asthma, beta thalassemia minor, tachycardia, partial lung collapse. Patient had known allergies codeine, penicillin. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), zinc (ZINC), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]). On 28Feb2021 at 16:00, patient experienced elevated heart rate, brain fog, anxiety, confusion, giddiness. Patient did not receive any treatment. AE did not result in Physician office and emergency room. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Developed white "patches" in vagina - painful, irritating. Biopsied - came back as unknown possible allergy. My GYN doctor has never seen this before - referred to GYN Oncologist - he also has never seen anything like this before.  Tried steroid treatment (4 weeks) - no relief actually was a little worse. i now have to return to the OB/GYN Oncologist for possible surgery for removal of affected area. Never had issues in past - 62 years old  2 office visits so far - next one scheduled to find out about surgery. Did not take second vaccine due to concern over reactions.
Information has been received on 09/20/2001 from a licensed visiting nurse concerning her 8 year old daughter who "about three years ago" was vaccinated with a dose of varicella vaccine. on 09/20/2001 it was reported that she "now" has varicella-like lesions. The pt sought unspecified medical attention. Follow-up info recorded on 11/18/2001 reported that the pt did not have chicken pox. It was noted that they were unable to determine what the pt had, "but the clusters were too close together to be chicken pox." It was also noted that the pt's brother developed similar symptoms. No further info is expected.
79 y.o. 6/22/1943   Admit Date:  8/3/2022   Discharge Date:   8/10/2022   Discharge Diagnosis:  Principal Problem:   Acute metabolic encephalopathy Active Problems:   Paroxysmal atrial fibrillation   Acute UTI   COVID-19     Hospital Course:  79 year old resident was admitted with UTI and generalized weakness. He was treated with Paxlovid for the Covid-19 infection at the facility. Urine culture grew E coli and the treatment was completed here. His facility determined they could not take him back due to him requiring assistance with mobility. He has been undergoing PT and OT here. He is accepted at facility and pre cert has been approved. He will be transferred there today.    Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.9 °F (36.6 °C) Heart Rate (Monitor): 99 Pulse: 94 BP: (!) 137/91 Respirations: 16 SpO2: 92 % 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 SOCIAL WORK   Significant Diagnostic Studies:   CT head, ABI, CXR   Operations: none   Disposition:  SNF   Discharge Condition:  Fair
Mom reported over the phone that her daughter had swelling, redness, warmth, and itching at injection site for 3 days. Not seen by a provider. Mom was told we would report to VAERS.
site where the patient got second shot was red a little red; arm was red a little red; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number unknown), as dose 2, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the site where the patient got second shot was red a little red. On an unspecified date, the patient's arm was red a little red. The patient asked if there was something the patient can put on it. 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.
Left arm where PREVNAR B injection was administered was red, bumpy, hot, painful right away after shot. 4 days later started getting worse, 1 week later seen at urgent care and diagnosed with cellulitis, got Abx, swollen jaw on left side, seen by dentist given mouthwash. May lose tooth due to infection. Has headache due to infection.
This spontaneous report has been received from a pharmacist referring to a 15 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 01-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. It was reported that the patient missed the second and third doses of GARDASIL 9 and subsequently on 20-JUL-2017, the patient visited the office to receive the next dose. No adverse effects were reported.
Patient reported joint ache, low-grade fever up to 100 F, and "flu-like" symptoms starting from the day when she received the vaccine and lasted until the day patient reported the problem to the pharmacy (11/23/2012).