chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022. Per FDA (Food and Drug Administration) guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted by local Public Health. Moderna found that the vaccine met the required activity to produce the needed immune response. This is Moderna Case Number CEA-2351. Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them. Patient has experienced no known adverse events.
small reaction; nauseous; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (small reaction), FATIGUE (fatigue), NAUSEA (nauseous), CHILLS (chills) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 28-Jan-2021, the patient experienced FATIGUE (fatigue). On 30-Jan-2021, the patient experienced NAUSEA (nauseous), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (small reaction). At the time of the report, VACCINATION COMPLICATION (small reaction), FATIGUE (fatigue), NAUSEA (nauseous), CHILLS (chills) and HEADACHE (headache) had resolved.            Concomitant product use was not provided  by the reporter.  Treatment information was not provided.Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-017643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07 May 2021.Added new event and updated outcome of events.
Large area of erythema, warmth, tenderness, swelling extending from left deltoid to antecubital area that began about 8 hours after vaccination.
Interchange of vaccine products; COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 as dose 6 (booster), single (Lot number: GJ6743) at the age of 65 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in right arm, on 24Apr2021 as dose 2, single (Lot number: ER8735), in right arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Nov2021 as dose 3 (booster), single (Lot number: 071F21A), in right arm and on 08Oct2022 as dose 5 (booster), single (Lot number: 027E22A), in right arm for COVID -19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: CALCIUM; VITAMIN B COMPLEX; LYSINE; SELENIUM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2023, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient took nirmatrelvir/ritonavir (PAXLOVID; Lot Number: GG4031) as treatment for five days starting on the first day of symptoms and a positive COVID-19 test (26May2023) until 31May2023.
2-3 hrs p/vax given pt arm became swollen & sore x 2 days;
Rash on left arm approximately 5-7 days after first dose.  Missed menstrual cycle for the month of March after the second dose in February.  Menstrual cycle returned in April.
Acute new onset of migraine or cluster headache on left side of temporal/eye area 3 days after first jab.
patient felt racing heart beat and faint.  patient sat down and received water.  breathed deeply after 5 minutes felt better patient remainded for 15 minute recomended time and felt fine before departing
I have had a lump at the injection point as well as decreased use of my left arm since March 4, 2021 with increasing pain and decreasing use of the left arm
aches/pains; Tiredness; fever with the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches/pains), FATIGUE (Tiredness) and PYREXIA (fever with the second dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination.     No patient had never been diagnosed with/tested positive for COVID-19.  No acute illnesses at the time of vaccination and up to one month before. No chronic or long-standing health conditions.  Concurrent medical conditions included Egg allergy. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (ENPRESSE) for Birth control.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (aches/pains), FATIGUE (Tiredness) and PYREXIA (fever with the second dose). At the time of the report, PAIN (aches/pains), FATIGUE (Tiredness) and PYREXIA (fever with the second dose) outcome was unknown.            No treatment medications were reported by the reporter.   This case was linked to MOD-2022-547111, MOD-2022-547115 (Patient Link).
Information has been received from a physician, concerning a 20 year old female patient with no pertinent medical history, who on unknown dates was vaccinated with the first, second, and third doses of Gardasil (lot #'s not provided).  There was no concomitant medication.  In October 2007 ("two to three weeks ago"), the patient visited the office, had a biopsy (unspecified) and was diagnosed with genital warts.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Fever; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, COVID-19 (Tested positive for COVID) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication provided no treatment given
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I have not gotten the second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not gotten the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 immunisation. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I have not gotten the second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not gotten the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I have not gotten the second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not gotten the second shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
1ST dose- Right arm- had a sore arm for almost 2 weeks, after 9 days, developed a rash a bout 4"x1" across the injection site. 2ND dose- Left arm- had very sore arm, within 1/2 hr, next day had a fever of 100.5, chills, and a red circle about 4" in diameter, with swelling and heat at the site.
Couldn't get out of bed and do anything. She called 911 and went to the hospital they ran test and stated she had a blood clot in the back of her head and she had a stroke. Her right side became paralyzed.
2nd booster.  I had a bad headache with other covid vaccines with each one lasting a little longer but until this last one headache never lasted more than one week and general pain from occipital neuralgia had been unaffected until this last one,  The severe day and night headaches began about 4 or 5 days after the vaccine (I did not have headaches like this prior to the vaccine). Of note, I felt like my head was going to explode or that I was going to have a stroke.  By chance I just happend to check my blood pressure and for a couple of days it was around 160-180/high with diastolic 90s.  Normal blood pressure for me is 110 to 130s  over the 70s - in othe words I not normally have high blood pressure. From the occipital neuralgia I did have occasional nocturnal headaches but never headaches during the day.  Now that I am about 7 weeks after the last vaccine, the headaches are all day and they are severe.  In addition, the other pain, some of which is undescribable but includes pressure, neck throbbing, constant head throbbing isl the worst it has ever been.  My blood pressure has returned to my normal blood pressure. I will not be getting another covid vaccine unless it is possible to get a vaccine that is limited to omicron only
Herpes Zoster (right upper chest and back), March 4, 2005 (had probable varicella disease at age 4 year per mother's history)
Pt given GARDASIL left deltoid on 9/27/09.  On 9/8/09 Pt developed numbness under left upper arm/axilla.  Exam normal except paresthesia under left axilla/upper arm.
Got a nose bleed this morning. Never do ordinarily. So far. Super tired like the flu. Just thought you should know ..so far
Pt recv vax on 12/10/98; on 12/11/98 pt exp erythema/ induration at vax site x 7 day
subjective fever-APAP; inconsolable crying >24hrs; poor feeding, vomiting;
From initial info received at manufacturer on 02/06/2003, it was reported that a 46-year-old female pt received Imovax Rabies, lot number U0595-2, given intra-muscular in the left deltoid as first booster on 01/30/2003. Pt experienced immediate nausea and lightheadedness. 24 hours later, pt reported having a severe headache and nausea that is still continuing. Nurse gave the vaccination reported that she obtained this info when returning to the pt's facility to administer vaccine to other patients. Pt received pre-exposure rabies series in past, had titer checked some point after series and titer was negative. The nurse stated that she did not have the dates of previous doses received on hand but could obtain them if requested. Pt was seen in ER/doctor's office, time and date not reported. Pt had no illnesses or pre-existing diagnosis at time of vaccination.
This spontaneous report as received from a 54 year old female consumer with back pain since approximately August 2013 and allergy to erythromycin (reaction, dates and manufacturer unspecified), refers to herself. No pertinent medical history was provided. On about 25-AUG-2014, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose and lot number not provided). No co-suspect therapies were reported. Concomitant therapies included hydrocodone/APAP, and Influenza virus vaccine (unspecified). On about 26-AUG-2014, the patient developed cellulitis at the site of ZOSTAVAX injection. On 29-AUG-2014, the patient was started on cephalexin (manufacturer unspecified) for the cellulitis. On 02-SEP-2014, the patient developed a sudden worsening of the pain in her back. The patient sought medical attention, she went to see a physician. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered from the worsened back pain and was recovering from the cellulitis. Additional information has been requested.
she started feeling not clear-headed; achy; tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: DISORIENTATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "she started feeling not clear-headed"; PAIN (non-serious) with onset 29Sep2021, outcome "unknown", described as "achy"; FATIGUE (non-serious) with onset 29Sep2021, outcome "unknown", described as "tired".  Additional information: Caller states it was the Pfizer 3rd dose and the name should be on the card she was given, caller confirms it was the Covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
slept all day after second shot; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in last weekend of Feb2021 at single dose for COVID-19 immunization. Patient mentioned that she had no reactions and slept all day in Mar2021 after second shot. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Was ?sick? for 9 days after receiving the Covid shot:  Doesn't feel right, Covid Brain, felt like back of brain was swelling and shaking and would get a head rush when bending over.  Felt like he had radiation in his blood like there was amphetamines in it, ?edgy?, fatigue, sleepy.  Denies fever or muscle aches.  Went to the ER on 4/4 or 4/11 not for sure on date.  They didn't do a COVID test and diagnosed him with depression due to his dog dying and divorce.
Approximately 1-5 minutes after patient received the vaccine, she began to feel tingling in her face. Patient sat in the pharmacy, removed her mask and was given water and a granola bar. A few minutes later she felt nauseous and vomited. After 15 minutes her mom asked if she could take her home to be more comfortable in her own space.
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored   VAQTA lot number N017094, expiration date 31-AUG-2018 (dose and route were not reported) for prophylaxis. No adverse effect was reported. Temperature: 9 grades Celsius to 25 grades Celsius "(10.1 C)" Time frame: 1 hour and 56 minutes. There was no previous temperature excursion involved. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1710USA003169: Original Case : 1710USA003115 US-009507513-1710USA003115: Original Case : 1710USA003115  US-009507513-1710USA003167: Original Case : 1710USA003115 US-009507513-1710USA003168: Original Case : 1710USA003115 US-009507513-1710USA003164: Original Case : 1710USA003115 US-009507513-1710USA003163: Original Case : 1710USA003115 US-009507513-1710USA003165: Original Case : 1710USA003115.
Fever (100.6), achiness. Altered administering Ibuprofen and Tylenol every 3 hours. Symptons lasted 36 hours.
Muscle Pain around  upper torso and back.  (Pain maybe 6 to 7). also feels tightness in chest. Also pain in upper shoulder.
Patient had already received a bivalent covid dose on 12/01/2022, so he received an extra one.
Cardiac Magnetic Resonance Imaging Demonstrating Acute Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Cardiac Magnetic Resonance Imaging Demonstrating Acute Myocarditis) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      The patient's past medical history included COVID-19 (She had a laboratory confirmed COVID-19 infection 7 months before) in November 2020.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MYOCARDITIS (Cardiac Magnetic Resonance Imaging Demonstrating Acute Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Cardiac Magnetic Resonance Imaging Demonstrating Acute Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Ejection fraction: 57 percent (normal) normal. In April 2021, Magnetic resonance imaging heart: normal (normal) Normal systolic function with no regional wall motion abnormalities, pericardial effusion, thickening, or enhancement, acute myocarditis (abnormal) On T2 mapping, there were skip areas of epicardial edema involving the basal inferior, basal, mid, and apical lateral segments (59 ms-66 ms, normal <55 ms) and nonischemic myocardial injury on native T1 mapping (1,117 ms-1,137 ms, normal 950 ms-1,050 ms), acute myocarditis (abnormal) Epicardial fibrosis and acute myocarditis (abnormal) Interstitial expansion (40%-44%, normal <28%). In April 2021, SARS-CoV-2 test: negative (Negative) When the patient was presented to the emergency department. In April 2021, Troponin I: 7.961 (High) (normal <0.034 ng/mL).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Cardiac Magnetic Resonance Imaging Demonstrating Acute Myocarditis) to be possibly related.    Concomitant medications were not provided. Treatment information was not reported. The ischemic evaluation of the patient was negative at the time of emergency visit. The patient developed chest pressure 25 days after her first dose of the Moderna COVID-19 vaccine.  Company Comment: This is a literature report of a 31 years old woman with no previous cardiac history, who developed myocarditis 25 days after receiving first dose of the product. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This is a literature report of a 31 years old woman with no previous cardiac history, who developed myocarditis 25 days after receiving first dose of the product. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
TOOK ONE ANTIBIOTIC PILL BETWEEN HIS FIRST AND SECOND VIVOTIF DOSES; This spontaneous case report (PVX2019-1856) was received from a nurse on 17-Jul-2019. It describes an adult male consumer who "took one antibiotic pill between his first and second Vivotif doses" (PT: Labelled drug-drug interaction medication error). The consumer was receiving oral Vivotif capsule (one dose every other day) for typhoid prophylaxis and oral doxycycline (100 mg) for acne like eruption around nose.  Case report: The consumer took one antibiotic pill between his first and second dose of Vivotif. He took first dose on 15-Jul-2019, then took doxycycline on 16-Jul-2019. Later, he took the second dose on 17-Jul-2019.  Action taken with Vivotif and doxycycline was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one antibiotic pill between his first and second Vivotif doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one antibiotic pill between his first and second Vivotif doses" was considered as not applicable.
Rash on torso. Blister or papules on foot OTC treatment & refer to primary care  Dr.
Patient felt dizzy after getting their second dose of Pfizer vaccine. EMS treated the patient and extended their observation time.
came into pharmacy 12/17/19 c/o pain, fever/chills, visible inflammation/redness
ISSUES PARTLY BECAUSE OF THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced issues partly because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of issues partly because of the vaccine was not reported. This report was non-serious.
Left arm where vaccine was administered was very heavy and sore.  Unable to lift for 2-3 days, right under my arm pit and around my left breast was swollen for two weeks.
Acute onset spiking fever, shaking chills, fatigue, dyspnea, non-productive cough.
This spontaneous report has been received from a pharmacist referring to a 74 year old female patient. The patient was allergic to ciprofloxacin (CIPRO), penicillin (PCN) and computed tomography (CT) contrast dye. Concomitant medication included levothyroxine sodium (SYNTHROID). Pertinent medical history was unknown. On 25-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date and dose not reported), intramuscularly (IM) for prophylaxis. On the same day, later vaccine administration, the patient experienced a rash down the same arm of the injection site. The patient sought medical attention. It was unknown if treatment was given for the event. The outcome of injection site rash was unknown. The causality between the event and PNEUMOVAX 23 was not provided.
FIFTEEN MINUTES AFTER VACCINE ADMINISTRATION THE PATIENT BEGAN FEELING: DIZZY, WITH DOUBLE VISION, PRESENTED WITH RUBOR IN CHEEKS AND WEAKNESS.
headache, fever-99.5, chills, body aches starting 11/19/21