chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My regular menstruation was x3 days late one month after receiving the Pfizer shot. I've been using Natural Family Planning and tracking my cycle for the last three years and I am normally very regular. I thought I might be pregnant because we are trying to conceive.
This spontaneous report as received from a registered nurse refers to a 77 year old female patient with diabetes and hypertension. The patient had no drug reactions or allergies. The patient had a breast cancer operation on 07-OCT-2013 (reported as 2 years ago). On an unknown date, a long time ago, the patient completed the series of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included metformin, glipizide and losartan potassium (manufacturer unknown). On 25-SEP-2015, the doctor completed the Hepatitis B surface AB immunity Quantity Test and the patient's levels were less than 5 (units not provided) and should be above 10 (units not provided). There was no treatment given to the patient for that event. The outcome of the event was not reported. The relatedness between the event and the RECOMBIVAX HB was not reported. Additional information has been requested.
Had been feeing very tired and weak earlier in the day and then complained of a severe headache. I took his temp and it was 102.5. Dr offices all closed for the weekend so he took 2 Aleve. He felt a little better, fever lessened. Saturday very tired and unusually crabby feeling weak again, resting most of the day. Saturday night very crabby and says he feels like "his frontal lobe is pushing out of his head". Temp 104.6. Called local ER and Dr called back. Advised we give Aleve again and if not better Monday come into office. Gave 2 Aleve 11:00PM. Fever lower around midnight and lots of sweating. Sunday morning. Still unusually crabby and very lethargic fever lessened.
Pt had been hospitalized for a surgical procedure unrelated to COVID.  Pt tested positive for COVID on discharge screening prior to dismissal to a SNF.  Pt was asymptomatic for COVID
Administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial did not undergo any temperature excursions. Date vial initially stored in the refrigerator was unknown. Total of 102 doses were given from LOT 026C21A with expiration date 24-Oct-2021. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant live follow-up: Additional reporter added.
Double vision; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2022, the patient experienced DIPLOPIA (Double vision). At the time of the report, DIPLOPIA (Double vision) outcome was unknown.            No Concomitant Products were reported. No Treatment information was reported. Patient stated that he got several tests run and they all came back negative.
Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: patient complains of weakness, dizziness. has not been able to go to work for the past 5 months. Patients actual dates of vaccines are 12/06/2021 and 12/27/2021.
I had what I considered to be a minor cold, but I had been with my family two or three days prior to that. They tested positive for COVID-19, so I tested myself for COVID-19 on 02/27/2023 the next day. My test came back positive so I contacted my doctor. I was given Paxlovid and azithromycin as well for treatment and was taken as prescribed. I still tested positive about a week later, and I started to getting severe symptoms of a cold a week after for about a week. After that, I felt better and resumed normal activity.
no adverse event; Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021) and NO ADVERSE EVENT (no adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1822811 and 042A21A) for COVID-19 prophylaxis.     It was unknown that the patient ever been diagnosed with or tested positive for COVID-19. It was unknown that the patient had acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions.    On 31-Mar-2021 at 2:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Dec-2021 at 12:05 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Dec-2021 at 12:05 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021).    Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event were unknown.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2023-704595 (Patient Link).
This spontaneous report as received from a registered nurse refers to a 73 year old female patient. The patient's medical history and concurrent conditions were not reported. On 19-JUN-2017, the patient was inadvertently vaccinated with a dose of VARIVAX (for prophylaxis, lot # M043582, expiration date 28-OCT-2018; dose and route of administration were not reported) instead of ZOSTAVAX. The dose of VARIVAX was reconstituted with sterile diluent. No adverse effects were reported. Additional information has been requested.
pt developed s/s of COVID and tested positive 9/17/21, was subsequently admitted to the hospital.
Eye inflammation; Eyelid scar; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (Eye inflammation), EYELID SCAR (Eyelid scar) and BACK PAIN (Back pain) in a 76-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced EYE INFLAMMATION (Eye inflammation), EYELID SCAR (Eyelid scar) and BACK PAIN (Back pain). At the time of the report, EYE INFLAMMATION (Eye inflammation) and EYELID SCAR (Eyelid scar) had resolved and BACK PAIN (Back pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Abnormal.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided.  On unknown date, the patient experienced scaring in eye but inflamation went down, still on blood pressure and back pain. On an unknown date, scaring in eye but inflamation went down resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of scaring in eye but inflamation went down unknown onset with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the events of scaring in eye but inflamation went down unknown onset, still on blood pressure and back pain was not provided.  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.
swollen under left arm pit; dizziness; diarrhea; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 15:15 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos thyroid" (unspecified if ongoing); "Sulpha allergy" (unspecified if ongoing); "soy allergy" (unspecified if ongoing); "eggs allergy" (unspecified if ongoing); "wheat allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; PANTOPRAZOLE; PROZAC; LOSARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0161, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 46 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: er8727, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 46 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 15:15, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset 04Dec2021 09:00, outcome "not recovered", described as "swollen under left arm pit"; DIZZINESS (non-serious) with onset 04Dec2021 09:00, outcome "not recovered", described as "dizziness"; DIARRHOEA (non-serious) with onset 04Dec2021 09:00, outcome "not recovered", described as "diarrhea". Therapeutic measures were not taken as a result of peripheral swelling, dizziness, diarrhoea.  Additional information: The case assessed as non-serious by the reporter. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  Follow-up attempts are completed. No further information is expected.
CHEST PAIN, ABDOMINAL PAIN Narrative:  Of note, patient also has metastatic melanoma for which he got a Pembrolizumab infusion on 1/4/21. Pt did not present to ED as advised and no f/u notes indicating outcome of event or resolution of symptoms.
Patient developed symptoms of MISC on 8/2/22; fevers began on 8/3/22 with a Tmax of 40.6 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, acute kidney injury, cough, chest pain, thrombocytopenia, abdominal pain, diarrhea, elevated liver enzymes, rash, mucocutaneous lesions/conjunctivitis, headache, and myalgias. Abnormal labs included elevated CRP, decreased platelets, and elevated AST. ECHO studies showed a coronary artery aneurysm and mitral regurgitation. Patient was admitted to the hospital on 8/7/22 and treated with IVIG, infliximab, and aspirin; he was discharged on 8/10/22.
Raw mouth; Injection site nodule; Stiffness; Pain; Flu like symptoms; Pain in extremity; Hepatic enzyme increased; Generalized aching; Pain in elbow; Fever; This spontaneous case was reported by a physician and describes the occurrence of STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No medical history  was provided by the reporter.  Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Pain in extremity), HEPATIC ENZYME INCREASED (Hepatic enzyme increased), MYALGIA (Generalized aching), ARTHRALGIA (Pain in elbow) and PYREXIA (Fever). At the time of the report, STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved, MUSCULOSKELETAL STIFFNESS (Stiffness) outcome was unknown and PAIN (Pain), PAIN IN EXTREMITY (Pain in extremity), HEPATIC ENZYME INCREASED (Hepatic enzyme increased), MYALGIA (Generalized aching) and ARTHRALGIA (Pain in elbow) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: Hepatic enzyme elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: F/U : ADR received on 20 07 2021 contains NNI
Patient had been isolating prior to COVID vaccinations, Received first dose on 1/21/21. Patient received COVID # 2 dose on 2/11/21. on 2/15/21 came into ED for 1930 for acute stroke symptoms. Found to have acute/early subacute infarcts  right MCA, followed by left MCA, consistent with a cardioembolic etiology given the multiple vascular territory distribution in light of recent MI and intracardiac thrombus. hospital c/b intracardiac thrombus and pulmonary emobli
Shot Tues 10/23, headache and muscle ache began Wed 10/4. Severe migraine, pain scale 9 at night. Thurs 10/25 nausea, headache and achiness continuously through the Sunday 10/38. Began to feel better after that.
Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number OS444, expiry date 16-SEP-2023) for prophylaxis.   On 16-SEP-2023, the patient received Infanrix. On 16-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of expired dose).  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: 25-SEP-2023 The nurse reported that a patient received a dose of an expired Infanrix, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
sore arm/ I also had it (worse I might add); This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The patient received 2 doses of shingrix vaccine and experienced worse sore arm. The patient stated that you were alive and did not had covid 19, then life is good. The follow-up would not possible as no contact details were available. For tolerance after 2nd dose refer case US2021AMR149448; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR149448:Same reporter
Pt. developed 2 1/2 cm area erythemic enduration at site of influenza vaccination.
fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 5 patients. This is 1st of five reports. This consumer reported for a patient (1st coworker) that:   A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced fever of 101 F and muscle aches 26 hours after receiving her second Pfizer- BioNTech COVID vaccine. Symptoms lasted approximately 7 hours and symptoms were relieved with treatment medication. Patient stated that 5 other individuals within her department also experienced similar symptoms after receiving the second dose. Treatment medication included one dose of Tylenol. The patient underwent lab test and procedures on an unspecified date which included body temperature of 101 F. Outcome for the events was reported as resolved on an unspecified date.    Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
Mild case of shingles two weeks after the shots; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1st dose received on an unknown date, refer case US2021AMR209331).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter reported that the shots helped, but he/she got a mild case of shingles two weeks after the shots. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR209331:Same reporter.
Muscle pain deep. Tingling in fingers. More like nerve pain started 1 day after getting injection. No adverse reaction after 1st dose. This is 2nd dose of ENGERIX-B 20mcg 1 mL. Patient report this on 9/13/10.
Developed papular vesicular rash, itchy and tender across back, buttocks and abdomen 30-50 spots.
Pink, slightly raised warm area about 2 inches below and medial to the injection site on the left upper arm.  It was not painful or itchy but continued for about 1 week gradually fading after about 3 days but the warmth was still there for several days.  No other symptoms were noted. No treatment was given.
feeling off; icky" although he "could still move around; fever; sore arm; This is a spontaneous report from a non-contactable consumer (patient). This 32-year-old male consumer received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm on 19Aug2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021 patient experienced sore arm, on 21Aug2021 feeling, icky" although he "could still move around, fever of recovering. The patient underwent lab tests and procedures which included pyrexia: 102-104 fahrenheit on 21Aug2021 with one of those ear thermometers. Therapeutic measures were taken as a result of fever took Tylenol extra strength and Advil liquid gels which helped to knock his fever down. Caller said he has heard rumors that symptoms are only "suppose to last two days" and so asked how long these symptoms will last? response received saying that fever and sore arm were both reported side effects. Informed caller that "In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter", emphasizing that a specific time frame is not noted for specific side effects. Encouraged caller to reach to his doctor for any symptoms that are prolonged or are worrisome to him for medical evaluation. The outcome for all events was unknown except fever it was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inadvertent vaccination using Pfizer vaccine whose "good to use" date was exceeded by 10 days. Vaccine still good within expiration window.
Right upper arm with 2.1 cm X 2.2 cm are of induration with slightly smaller area of erythema. ? tender to touch.
After receiving H1N1 vaccine in the gym at school clinic, pt returned to class.  Approximately 15-20 minutes later, she returned to the gym and reported that she had "passed out" in class.  She was alert and oriented, had walked to the gym on her own, and reported no ill feelings at that time.  She reported that she had not eaten that day.   Observed for 15 minutes by school nurse and provided with juice and crackers. Returned to class/lunch.  Pt stated that she has had past episodes of "passing out" upon venipuncture.