chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling very sick; Dizziness; Remaining head droning/puffing in her head; COVID19-like symptoms; Anxiety; Head pounding; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling very sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Remaining head droning/puffing in her head), SUSPECTED COVID-19 (COVID19-like symptoms) and ANXIETY (Anxiety) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2021.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced MALAISE (Feeling very sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Remaining head droning/puffing in her head), SUSPECTED COVID-19 (COVID19-like symptoms), ANXIETY (Anxiety), HEADACHE (Head pounding), FATIGUE (Fatigue) and NAUSEA (Nausea). On 26-Aug-2021, MALAISE (Feeling very sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Remaining head droning/puffing in her head), SUSPECTED COVID-19 (COVID19-like symptoms), ANXIETY (Anxiety), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved and HEADACHE (Head pounding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.  Reporter said she had COVID-19 positive 5 months ago and experienced post-covid symptoms for 5 months.
Person received their first dose of Moderna by another provider.  We used the off label guidance from CDC to complete the series even though they were under approved age.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Pulmonary HTN" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: contrast media" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Statins, reaction(s): "known allergies: Statins". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Onset of flu symptoms, stating with upper respiratory (head congestion, sneezing, runny nose), fever of 100F for 2 days, body aches, muscle aches.
This spontaneous report was received from a medical assistant refers to a 25 year old patient of unknown gender. On 17-NOV-2015, the patient was vaccinated with first dose of RECOMBIVAX HB 0.5 ml. The reporter stated that the patient received the pediatric dose of RECOMBIVAX HB on 17-NOV-2015. No symptoms were reported. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Patient complained of a tingling sensation running down her arm (R Arm) post vaccination. VS were taken and she was monitored, tingling subsided after about 15 minutes,
PATIENT HAD A SEIZURE APPROXIMATELY 10 MINUTES AFTER HE RECEIVED THE VACCINATION. THE SEIZURE LASTED ABOUT 45 SECONDS TO 1 MINUTES. THE PATIENT WAS ABLE TO ANSWER QUESTIONS RELATED TO TIME AND SPACE AFTER HE RECOVERED FROM THE SEIZURE.
Patient had vaccines on 12/17/2008, 2/23/2009, and 6/23/2009 and began experiencing a swollen finger in 5/2009. This proceeded over the next few months to her finger joints and down her tendon to her wrist. She is diagnosed with psoriatic arthritis because of her inflammation of joint and tendon (tenosynovitis) in her left hand. They want to treat her with methotrexate to attack this auto-immune disorder. 11/23/09 Medical records received for date 5/28/09. DX: left middle finger tenosynovitis. Pt presented w/ c/o left mid. finger swelling, unable to recall any injury. OV 8/4/09 Cont. c/o swelling left mid. finger no extends to palm of hand. Ref. to ortho.
This spontaneous case reported by a consumer, describes the occurrence of burning sensation on toes and peripheral swelling (right leg swelling after receiving the Moderna first shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced burning sensation on toes and peripheral swelling (right leg swelling after receiving the Moderna first shot). At the time of the report, burning sensation on toes and peripheral swelling (right leg swelling after receiving the Moderna first shot): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Lymph node in arm pit swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node in arm pit swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node in arm pit swollen). At the time of the report, LYMPHADENOPATHY (Lymph node in arm pit swollen) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Information has been received from a health professional concerning a 4 year old female patient who on 01/01/?? was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on approximately 04/22/2004, the patient developed breakthrough chickenpox.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  No additional information is expected.
No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Dec-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 21-Dec-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    Concomitant and treatment medications were not reported.  Company comment: This spontaneous case concerns a 49-year-old, female patient with maternal exposure during pregnancy with no relevant reported medical history, who experienced the unexpected non-serious event of Maternal exposure during pregnancy with No adverse event that occurred in context to the administration of third dose of mRNA-1273 bivalent BA.4-5 vaccine. Last menstrual period and estimated date of delivery were not provided. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 bivalent BA.1 vaccine is not affected by this report.   Reporter did not allow further contact
Dx GBS, paralysis from waist down hospitalised with tremors  3/19/2021
Light headedness and soreness at the injection site developed last night. This morning I woke up with muscle pain, headache, and fatigue.
Had a sudden onset fever which reached 103 the evening of the injection.  There was muscle soreness, fatigue, my pulse was above 80 all night and reached 100 during the peak of the fever.  By the next morning, the fever had dropped to 100, fatigue remained and a slight headache appeared.  The headache was gone by noon, the fatigue remained all day.  The evening after the injection, a slight fever returned and then stopped.  Two days after the injection, there were no further averse reactions other than slight soreness in the injection site.  I am no longer fatigued and feel fine.  Hope this information helps.
I had 1st dose my knees have had severe pain since; This case was reported by a consumer via interactive digital media and described the occurrence of knee pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than 3 weeks after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was not recovered/not resolved.   It was unknown if the reporter considered the knee pain to be related to Shingrix.     Additional Information: GSK receipt date:23-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient-self reported this case. The patient had 1st dose of Shignrix on 3rd May and his/her knees have had severe pain since. Additional Supportive Information: Foll0w-up could not be possible as no contact details were available.
pain on right side, didn't feel well, nauseated, restless, overall doesnt feel well
Information has been received from a pharmacist concerning a 25 year old female inpatient with Crohn's disease and allergic reaction to tetracycline who on 23-APR-2010 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number unspecified). The pharmacist reported that the patient who was hospitalized with Crohn's disease was vaccinated with PNEUMOVAX 23 and the patient had injection site swelling. At the time of the report the outcome of the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Walk-in appointment. SARS-CoV+SARS-CoV-2 Ag Resp Ql IA.rapid test performed on 7/19/21 and came back positive. Case investigation interview with patient has not been performed as of the time of this note.
25 yr old white female was vaccinated w/ MMR shortly after vaccination she became pregnant, & subsequently had a therapeutic abortion.
Facial numbing within 10 minutes; subsided and gone within 40 minutes.   Had read that bell's palsy was possible side effect so was not worried.
Arm pain at injection sight 6 hours later along with swollen glands.  Four days later a migraine hit around 2:00 pm and lasted at least 12 hours.  Also swollen shoulders and shoulder and back pain.  The following week I experienced sudden shortness of breath that last for approximately 10 minutes while I was at work with profuse sweating on my lower back.  The shortness of breath occurred agin the next day while working around the home. and lasted about 5  minutes.
Expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 29-Oct-2021, the vial was placed in the refrigerator. The vial did not have any temperature excursion and the patient had no adverse event. No Treatment medication reported.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 40 year old female. Initial information was processed along with the additional information received on 08-DEC-2021 and 10-DEC-2021. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no significant medical history. Patient always wore a mask, prior to and after vaccination whenever left the house. On 23-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: 23-AUG-2021) dose was not reported, 1 total, administered to left arm for prophylactic vaccination (dose number in series: 1). Concomitant medications for unknown indication included ascorbic acid, multivitamin [vitamin NOS], and zinc.  On 26-NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A and expiry: Unknown) dose was not reported, 1 total, dose number in series: 2, administered to left arm for prophylactic vaccination. On 27-NOV-2021, the patient experienced body pains. (Subsumed under confirmed COVID-19 infection event) On 28-NOV-2021, she experienced cough. (Subsumed under confirmed COVID-19 infection event) On 29-NOV-2021, the patient lost sense of smell. (Subsumed under confirmed COVID-19 infection event) On 30-NOV-2021, PCR test was performed which showed positive for covid-19 (coded as Confirmed COVID-19 Infection and Confirmed Clinical Vaccination Failure) (dose number in series 2). The reporter noted that the lab had called the patient to report positive covid-19. They also mentioned in report detected antibodies (Ab). Laboratory data included: COVID-19 PCR test was positive. On 01-DEC-2021, a second PCR lab test was performed to verify the results, which also produced a positive covid-19 result. Laboratory data included: COVID-19 PCR test was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000205874. Confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. This case, involving the same patient is linked to 20211217766.; Sender's Comments: V0:20211217118-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I got a bad skin rash on my face and neck, that itches and burns. Went to dermatologist. Was prescribed steroids to correct it. Rash came back as soon as meds were gone. It doesn?t go away. Red and raised. Very uncomfortable.  I have had this ever since 10/8/21
-low grade fever the same evening / 7h  after vaccination -vomiting in the morning -high fever (40degC/104degF) next day 23h after vaccination, tachycardia, tachypnea, sleepiness, no appetite -pediatrician was called, parents were told that this might be normal the day after immunization and that there is no need for an appointment and check up -episode of centralization, cold and blue hands and lips in the evening -parents went to hospital to check oxygenation  -in hospital, centralization was resolved, parents were told that centralization happens sometimes with high fevers, O2 (finger) was 98%, child was 'warm' and tachycard. Parents decided to take child home in accordance with nurse and give antipyretic suppository -child died at 2 p.m.the next day, reanimation was unsuccessful -autopsy showed bacterial meningitis and septicamia, haemophilus influenza serotype A (HIA), bilateral adrenal haemorrhage
patient missed  the recommended window for her second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose) 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 10-Jan-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 (patient missed  the recommended window for her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Severe headache; Pain at the injection site; Body aches severe; Digestive distress; Stomach ache; Feeling of needing to vomit; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 03Jun2021 at 16:30 (at the age of 16 years old) as a single dose for COVID-19 immunisation. Medical history included peanut allergy and corn allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 13May2021 at 16:15 (at the age of 15 years old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021 at 01:00, the patient experienced severe headache, pain at the injection site, body aches severe, digestive distress, stomach ache and the feeling of needing to vomit. Therapeutic measures were taken as a result of the events which included treatment with ADVIL. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events severe headache, pain at the injection site, body aches severe, digestive distress, stomach ache and the feeling of needing to vomiting was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Onset of urticarus, generalized on day 13 after smallpox vaccination. Some bruising; vasculitive character to lesion on foot. Follow up states: Pt experienced urticaria day 13 after smallpox vaccination. Pt was evaluated and treated with antihistimines. Sx completely resolved. Would like to point out that the 3rd anthrax dose is recorded as being administered on 23 Jan 2003- just 3 days before the onset of urticaria. This cannot be ruled out as a possible cause of the urticaria. Pt is atopic with history of urticaria prior to vaccinations therefore this cannot be ruled our as a cause either.
This spontaneous report as received from a physician refers to a 20 years old female patient. The patient did not have pertinent medical history and no drug reactions/allergies. In October 2013 (date unspecified) the patient was vaccinated with first dose of GARDASIL (dose, route, lot # not reported). On 07-JUN-2014 or 08-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, route, lot # not reported). There was no concomitant medication. On the morning 05-JUL-2014 the patient woke up with blurred vision in both eyes. She ignored it for the day because she assumed it was her contacts that were causing the issue. On 06-JUL-2014 she awoke with worsening vision and went to unspecified hospital for Emergency Room visit, but they were not helpful. She saw a doctor on 08-JUL-2014 and was diagnosed with Exuda Retinal Detachment in both right and left eyes. The patient was treated with prednisone (manufacturer unknown) 60mg daily. The patient stated she had some improvement but is not fully recovered and the condition is disorienting. No lab diagnostic studies were performed. The relatedness between Exuda Retinal Detachment and GARDASIL was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Fever - one day, chills - two days, body aches - two days, stiffness - 1 day, headache - 3 days, diarrhea - 1 day, lethargy - 1 day
REACTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number.  No concomitant medications were reported. On an unspecified date, the subject experienced reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from reaction. This report was non-serious.