chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 30.Jul.2009 from the treating physician. This 55-year-old patient took the 1. VIVOTIF capsule (Batch no.: unknown) on 09.Jul.2009. He developed myalgia, severe headache, fever of 106 degree F, chills and night sweats. Follow-up information is expected. VAERS form received on 04.Aug.2009. VAERS ID: not yet provided. This 55-year old staff physician, active duty in generally excellent health without illness at the time of vaccination, predeployment, who finished the 4-dose of oral VIVOTIF (Batch no.: unknown) on 15.Jul.2009 (starting 09.Jul.2009, every other day with no other vaccines as prescribed). After the first dose on 09.Jul.2009, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but no rigors or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. He denied any nausea, vomiting, diarrhoea or abdominal pain. Temperature resolved by day 6, but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31.Jul.2009, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis with normal bilirubin and muscle enzymes). Had measurable anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. The patient did not receive any other vaccinations within 4 weeks prior to vaccination. Extensive external consultations: Concurrence of infectious disease, special experts at the hospital and manufacturer representative provide information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in an non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but is still pending. The reporting physician does not consider this as a 15-day report. Follow-up information received on 05.Aug.2009: Batch no. of VIVOTIF was 3001583.
sore arm; diarrhea; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Immediately after injection at 11:44 am today, patient stated she's having difficulty breathing. EMS contacted immediately. At 11:45 am today, she stated she was feeling a bit better at around 11:47 am. When EMS arrived she taken to local hospital.
Tingling in right 15 days first dosage.; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 16:00 (at the age of 36-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure increases (high bp), ocular migraine. The patient had no known allergies. Concomitant medication(s) included amitriptyline; amlodipine, both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccination and not tested post vaccination. The patient experienced tingling in right 15 days first dosage since 17Jan2021 12:00. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Felt fine.  All good until I tested positive.  Dr. prescribed Paxlovid300MG/100MG ten dose meds.
Patient states he has loss of feeling in the thumb and pins and needles sensation in the arm and rest of the fingers
Extremely tired and fatigue; He had headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (He had headache) and FATIGUE (Extremely tired and fatigue) 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.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (He had headache). On 08-Apr-2021, the patient experienced FATIGUE (Extremely tired and fatigue). At the time of the report, HEADACHE (He had headache) had resolved and FATIGUE (Extremely tired and fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rash Redness, burning, swelling, indurated rash to L. arm Narrative:
Left eye bleeding 9:30AM 4/24/2021 Noticed blood in eye, no pain, realized it was bleeding
Administration of a first dose of Kinrix to a patient; Administration of a second dose of Kinrix to a 4 month old female patient; Administration of a second dose of Kinrix to / patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th May 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 24th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported for the 1st dose of Kinrix. The reporter stated that the 4 months old patient received Kinrix, which led to inappropriate age at vaccine administration. The patient was vaccinated with 2 doses of Kinrix, which led to extra dose administered. No further events were reported. The reporter consented to follow up.
This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, concurrent conditions was reported. On an unknown date the patient was vaccinated with VARIVAX (Merck). No concomitant medications were reported. The nurse reported that 5 doses of VARIVAX (Merck), that had been improperly stored, were inadvertently administered to unspecified patients on unspecified dates. No adverse effects reported. There was no product quality complaint. This is one of the two reports received from the same reporter (MARRS # 1408USA007972). Additional information has been requested.
This spontaneous report as received from a health care worker (also reported as medical assistant) refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 12-OCT-2015, the patients were vaccinated with improperly stored VAQTA (lot # L023232, expiration date 25-FEB-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
rt deltoid devel an area of redness measuring 5cm x 4 1/2 cm w/some tenderness initially that resolved by clinic visit on 17AUG94;
warmth at the injection site; red blotchiness at the injection site; headaches; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), LETHARGY (lethargic), VACCINATION SITE WARMTH (warmth at the injection site) and RASH MACULAR (red blotchiness at the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE), AMOXICILLIN TRIHYDRATE (FLEMOXIN SOLUTAB), CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (headaches) and LETHARGY (lethargic). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth at the injection site) and RASH MACULAR (red blotchiness at the injection site). At the time of the report, HEADACHE (headaches), LETHARGY (lethargic), VACCINATION SITE WARMTH (warmth at the injection site) and RASH MACULAR (red blotchiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Large red welt appeared next day 7 days after injections received 4 shocks from ICD after 7 years with no issues
Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX. On an unspecified date the patient developed a generalized rash. Specimens from the rash was sent to the CDC for PCR analysis. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX. She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first does. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX were stored and administered appropriately, and all patients involved were normal healthy children. Follow-up information was received on 01-JUL-2008 from a nurse practitioner concerning a ten year old male student with autism and allergy (hives) to AUGMENTIN who on 16-DEC-1998 and 30-APR-2008 was vaccinated subcutaneously with a first and second 0.5 ml doses, respectively, of VARIVAX (Lot # of second dose 659429/1917U, expiration November, 2009). Concomitant therapy included FOCALIN and therapy unspecified. "3-4 days" after receiving the second dose of VARIVAX (also reported as 03-MAY-2008) the patient developed fever and flu-like symptoms. On 06-MAY-2008 the patient developed erythematous, maculo-papular rash and a few vesicles. At the time of the report the patient had not recovered from the events yet. This is one of several reports received from the same source. Additional information has been requested.
ACUTE NON ST ELEVATION MI 1/15/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt devel temp 102-103 hives was examined in ER (6 days p/vax);
chest pains; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains). At the time of the report, CHEST PAIN (chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
I felt feverish in the afternoon after I got my shot. I proceeded to feel woozy and fatigued and my condition worsened to the point where I was having chills and body aches, even to the point where I was shaking.
Flat macular (L) 11's x 10 cm erythema (R) thigh 9x8 cm w/ warmth CT AB, no respiratory distress.
pt recv 1st dose of varivax 4/13/98 & 4/24 pt woke w/fever 103 which increased to 105, went to ER w/reddened raised rash, several vesicles head to toe. also pt vomited once & had poor appetite. treated w/IV antibiotics &  hydration
nausea; joint pain; injection site very red and swollen; injection site very red and swollen; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; head ached; felt out of sorts; left arm kept going numb; eyelids were heavy; Swollen gland; This is a spontaneous report from a contactable consumer (patient) reporting for herself.    A 68-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Feb2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 68 years). Medical history included asthma and allergies from an unknown date and unknown if ongoing. Concomitant medications included vitamins and thyroid medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced nausea, joint pain, injection site very red and swollen, throat and mouth felt swollen and very dry, head ached, felt out of sorts, left arm kept going numb, eyelids were heavy, swollen gland on 20Feb2021 23:00. Reporter stated that, later that night at bedtime, started with nausea, joint pain, injection site very red and swollen, then my throat and mouth felt swollen and very dry as if someone put a wad of cotton down my throat. My head ached and felt out of sorts. My left arm kept going numb. My eyelids were heavy. Swollen gland. This intensity continued for 5 days, and still had some side effects now, 3 weeks later. Therapeutic measures taken as a result of the events included started taking antihistamines. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
HEADACHE, TEMPERATURE 101.4, DEEP MUSCLE ACHES, FATIGUE. AFTER DAY TWO AFTER INJECTION I STILL HAD A HEADACHE THAT I COULD'NT GET RELEIF FROM WITHOUT MIGRAINE MEDICATION. DAY 3 I HAD A VERY SORE AND SWOLLEN ARM BUT OTHER SYMPTOMS SUBSIDED. DAY 4 A LITTLE FATIGUE BUT FEELING GOOD.
This spontaneous report was received from the registered nurse and refers to a patient of unknown age and gender. On 02-DEC-2014, the patient was given ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Muscle soreness of bilateral legs and hip joints/ got worse; pelvic pain; Couldn't walk; Drag showed inflamed pelvic girdle; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Solution for injection, lot number: 42 (as reported)), via an unspecified route of administration on the right arm on 15Jan2021 08:30 at single dose for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medication included metoprolol, fish oil, calcium and monascus purpureus (RED YEAST RICE).  The patient had known allergies: DILAUDID.  The patient experienced muscle soreness of bilateral legs and hip joints on 22Jan2021 and it got worse. Patient also experienced deep pelvic pain on an unspecified date in Jan2021 and went to physician on 24Jan2021. The patient couldn't walk in Jan2021. Cat scan showed no apparent reason, drag showed inflamed pelvic girdle on Jan2021. The outcome of the events was not recovered.; Sender's Comments: Case serious due to Pelvic inflammatory disease, classified Medically Significant and always serious event, per List Critical Term. Other reported events were non-serious. Based on available information, the Company considered that all reported events were possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Fatigue after 18 hours; Fever of 102.5°F; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue after 18 hours) and PYREXIA (Fever of 102.5°F) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 19-Oct-2023, the patient experienced FATIGUE (Fatigue after 18 hours). 19-Oct-2023, the patient experienced PYREXIA (Fever of 102.5°F). At the time of the report, FATIGUE (Fatigue after 18 hours) and PYREXIA (Fever of 102.5°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5A°F.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
feeling clouded; Rash; Not feel well; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient have now broken out with a rash as well so not feel well. If this gets worse patient will go to ER. As patient was also feeling clouded and not clear headed. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Swollen lymph node; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 10:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include unspecified birth control medication from an unknown start date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Oct2021 at 05:30, the patient experienced swollen lymph node. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This study case was received from the investigator on 22 October 2012. A 23-year-old male subject, with a past medical history of dizziness and fainting spells received a ACAM2000, SP Biologics Co., (lot number not reported) on 20 June 2012; and an ANTHRAX 2, other manufacturer, (lot not reported) on 27 May 2012. Thirteen days post vaccination with ACAM2000 and 37 days post vaccination with ANTHRAX 2, on 03 July 2012, the subject was diagnosed with other specified acute myocarditis. On 30 June 2012, the subject had a electrocardiogram (ECG) with results reported as abnormal. On same day, 30 June 2012, the subject also had a Troponin I laboratory test and an echocardiogram with results that was reported as normal. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
28Jun95 pt recv 1st dose vax IM. 31Dec97 pt devel varicella w/14 lesions. 1Jan98 pt exp syncopal episode. Approx 7-10 days after these exp pt recovered.
Had sore throat, itchy throat, cough, running nose and shortness of breath started yesterday.  But shortness of breath has gone away this morning.  Anything she need to do?