chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Apr-2023, the patient experienced COVID-19 (Tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 25-Apr-2023 at a dose of 150mg/100mg dose pack in blister packs, taken once. At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2023, SARS-CoV-2 test: (Positive) culture source was nose swab.         Concomitant medication was not reported.  Patient received all vaccines from Moderna. First dose on 15-JAN-2021 in early evening about 17:30 (lot: 025L20A, expiration: Unknown). Second dose on 12-FEB-2021 in late morning (lot: 010M20A, expiration: unknown). Third dose on 15-OCT-2021 like about 13:30 (lot: 027C71A, expiration: Unknown). Fourth dose on 01-JUN-2022 in morning (lot: 025L2113, expiration: unknown). Patient received fifth dose in early afternoon.   Patient had all vaccinations and all of boosters and still got COVID. Patient started taking Paxlovid on 25-Apr-2023. Patient had a yucky taste in mouth, began right after took first dose of Paxlovid, immediately happened within 15 minutes. Took first dose of Paxlovid at 11:30. Expiry Date of Paxlovid was on an unknown date in Apr-2023. Patient had not visited Emergency Room or Physician Office.
lump above her clavicle like swollen lymph node (left side); fever for several days between 99-101 F; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever for several days between 99-101 F) and LYMPHADENOPATHY (lump above her clavicle like swollen lymph node (left side)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031M20A) for COVID-19 vaccination.     Previously administered products included for Shingles: Vaccines on 30-Oct-2020. Concurrent medical conditions included Hypothyroidism and Drug allergy (Allergy to Bactrim). Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure, LEVOTHYROXINE for Hypothyroidism, ACETYLSALICYLIC ACID (ASPIRIN LOW), VITAMIN D3 and CALCIUM for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 23-Mar-2021, the patient experienced PYREXIA (fever for several days between 99-101 F). On 24-Mar-2021, the patient experienced LYMPHADENOPATHY (lump above her clavicle like swollen lymph node (left side)). On 22-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PYREXIA (fever for several days between 99-101 F) outcome was unknown and LYMPHADENOPATHY (lump above her clavicle like swollen lymph node (left side)) had not resolved.            Concomitant medicines include Levothyroxine, Hydrochlorothiazide, Low dose aspirin, Calcium, Vitamin D3.  Treatment drugs were not provided  Action taken with mRNA-1273 in response to the event was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: significant information added- 2nd dose batch number added; Sender's
First Dose Heplisav-B Second Dose Engerix; Typical Injection Site Pain; Initial Report Received on 11-Jun-2021  A pharmacy technician in the US (TX) reported that a 20 year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  No relevant medical history was reported.   No relevant concomitant medications were reported.  On 27-Apr-2021, the patient received the first dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC # 4352806050; route and site were not reported).   On 10-Jun-2021, the patient received the second dose with Engerix.   At the time of reporting, the reported stated there have been no adverse reaction except for typical site pain, but nothing more extreme than that. No other information was provided.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the event as non-serious.
No Adverse Event; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; Product storage error; This spontaneous report was received from a pharmacist refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  07-JUN-2023, the patient was vaccinated with one dose of expired and improper storage varicella virus vaccine live (oka/merck)(VARIVAX), lot#: W0252273, expiration date reported as: 02-JUN-2023, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  On 02-MAR-2023, administered dose of vaccine was exposed to the temperature excursion of 70 degrees Fahrenheit for 9 minutes. There were no additional adverse events reported (expired product administered, product storage error, no adverse event).  Lot number W0252273 has been verified to be non-valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) and does not match any Company product.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA007830: US-009507513-2306USA007844: US-009507513-2306USA007881: US-009507513-2306USA007905: US-009507513-2306USA007844:
One day following injection developed pain in the axilla, scapula with paresthesias and electrical sensation down the right arm to the thumb and first 3 fingers aggravated by any movement of the arm. Tapping on multiple locations on the arm elicits electrical shock sensation down the arm to the fingers. There has been a gradual improvement over the last 6 months with resolution of the axillary, scapular and upper arm pain and paresthesias. It persists in the forearm, thumb, index finger and third finger. Strength is preserved though there is some decrease in sensation in the thumb, index finger and. third finger.
day 1: pain?welling?redness day 1 evening: muscle aching  day 2 and 3: muscle aching and fatigue  day 4: recovered  day 8: pain,welling, redness appeared again day 11: recovered
SENSE OF SMELL DECREASED FROM NORMAL; SENSE OF TASTE DECREASED; LINGERING AFTERTASTE AND AFTER  SMELL SENSATION; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use (2 per week), and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient experienced ulcerative colitis when treated with adalimumab for ulcerative colitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced sense of smell decreased from normal. On 10-MAR-2021, the subject experienced sense of taste decreased. On 10-MAR-2021, the subject experienced lingering aftertaste and after smell sensation.  On 26-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on 10-MAR-2021, and had not recovered from sense of smell decreased from normal, sense of taste decreased, and lingering aftertaste and after smell sensation. This report was non-serious.
Woke up with hive-like bumps that itch; This is a spontaneous report from a non-contactable healthcare professional. A 32-year-old female patient received bnt162b2 (BNT162B2; lot number: EK5730; expiration date: unknown), intramuscular left arm on 17Dec2020 17:00 at single dose for immunization. Medical history included hives a few weeks ago. She is not pregnant. The patient's concomitant medications were not reported. The patient stated that she woke up on 18Dec2020 07:00 AM with hive-like bumps that itch. There was no treatment given. The patient added that it maybe unrelated as she had hives, a few weeks ago. The vaccine was given in a hospital. The patient did not have other vaccine in the last 4 weeks. The patient was not diagnosed with COVID-19 prior to the vaccination and was not COVID tested post vaccination. The outcome of the event was unknown.   No follow up attempts are possible. No further information is expected.
DIARRHEA; HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered to the left deltoid, on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, headache, and pain at injection site on 08-APR-2021. This report was non-serious.
Pfizer COVID-19 Vaccine   Patient presents today for medical observation of feeling dizzy, sweaty and pre-syncopal episode s/p COVID - 19 vaccine # 1. Patient was monitored for a total of 30 minutes. Patients vital signs initially SBP in the 80's and HR in 40's, patient placed in Trendelenburg position with increase in BP to 109/76 and HR 68. Denies feeling of chest tightness, swelling of the face/lips/tongue and pruritus. Patient reports resolution of symptoms prior to being discharged.
I received the Covid 19 Booster (1st shot) on 10/25/2021.  Normal arm (shot area) pain at first.  After 1 week pain intensified.  Incredible pain to the entire left arm and hand and fingers.  Pain was there for 3-4 months. I received the Covid 19 Booster (2nd shot) on 4/11/2022.  Normal arm (shot area) pain at first.  Same thing after 1 week pain intensified. Incredible pain to the entire left arm and hand and fingers.  Pain has not let up since April 11, 2022.  I've met with PCP, Neurologist and they do not know what is causing the daily pain.  Finally saw Chiropractor on 6/13/2022, he stated arm (muscles are very tight).  Also mentioned that he is seeing many patients with same arm pain.  The pain is all day/all night.  I cannot do anything without the pain intensifying.  I cannot live on ice packs and ibuprofen. I received the Moderna vaccines on 3/26/2021 (lot #044A21A) and 4/23/2021 (lot 044B21A) with no adverse events or symptoms. Symptoms only developed with BOTH Covid Boosters.
3-4 p/DPT/OPV t103.4, cried x 2 days, wouldn't walk; leg w/o swelling or redness;
SkinRash atypical hives all over her body for approximately 9 months Narrative: Developed atypical hives all over her body approximately 10 days after the second dose of the Pfizer vaccine, was evaluated by both a allergist and a dermatologist, which both identified the vaccine as the likely cause of the reaction. Mentioned it might be a form of serum sickness
with the second booster dose her daughter felt sick,; the second booster dose her daughter had headaches; pain in her right arm in the injection site; First booster dose - 22Dec2021 andoSecond booster dose-04Apr2022; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (with the second booster dose her daughter felt sick,), HEADACHE (the second booster dose her daughter had headaches), VACCINATION SITE PAIN (pain in her right arm in the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster dose - 22Dec2021 andoSecond booster dose-04Apr2022) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 018F21A, 004M20A and D37K20A) for COVID-19 vaccination.     The caller stated that her daughter had no allergies.  The patient's past medical history included COVID-19 (but doctor refused to test people. For this reason she did not have a positive test) in March 2020.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster dose - 22Dec2021 andoSecond booster dose-04Apr2022). On an unknown date, the patient experienced ILLNESS (with the second booster dose her daughter felt sick,), HEADACHE (the second booster dose her daughter had headaches) and VACCINATION SITE PAIN (pain in her right arm in the injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (with the second booster dose her daughter felt sick,), HEADACHE (the second booster dose her daughter had headaches) and VACCINATION SITE PAIN (pain in her right arm in the injection site) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster dose - 22Dec2021 andoSecond booster dose-04Apr2022) outcome was unknown.      No concomitant medication was reported.  It was reported that patient was now feeling better.  This case was linked to MOD-2022-534390 (Patient Link).
Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a female patient who on an unspecified date, was vaccinated with first dose of GARDASIL. The physician reported that the patient became pregnant after receiving her first dose of GARDASIL. At the time of the report the patient had already given birth. On follow-up information it was reported that the patient was a 18 year old female patient with a history of low platelet count and no previous pregnancies, who on 17-OCT-2007, was vaccinated with the first dose of GARDASIL (lot# 654510/0962F). Concomitant medication included prenatal vitamins. On 08-NOV-2007, the patient had an ultrasound which results were an intrauterine pregnancy of 6 weeks and 2 days. On an unspecified date, during pregnancy, the patient had repeat CBC to follow PLT count which dropped to 109,000. On 20-MAY-2008, the patient went to preterm labor and had a normal male liveborn infant. There were no congenital anomalies. The baby's weight was 4 pounds 2 ounces, length 18.5 inches, head circumference 13 inches and apgar score 8/9. It was 33 weeks from LMP. Because of prematurity the baby was treated in the new born nursery for 3 days with ampicillin and gentamycin. Baby's weight at discharge was 4 pounds 8 ounces. On 05-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (lot# 660387/1967U) and on 23-JUL-2008, the patient was vaccinated with the third dose of GARDASIL (lot#660393/0067X). No further information is available.
Patient is 12 years old but received pediatric dose. No issues at time of administration or during 15 minute observation period. Mother notified after they left the facility. Patient will receive adult dose for second dose in series.
School requires two doses of meningococcal vaccine MCV4 (8 weeks apart) prior to beginning of senior year. Patient received 1st dose on 6/14/2018 and that night found one of her lymph nodes swollen. Over the next few days, it progressed to very swollen lymph nodes all throughout neck. She found it painful and hard to swallow.
This spontaneous case was initially received on 08-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 06-Oct-2015 - 06-Oct-2015, batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Oct-2015, the patient inadvertently administered expired AFLURIA PFS. The reporter stated that she heard no complaints from any of the 10 patients. She also confirmed that no patients were pregnant. For relevant test results see appropriate report section. Reporter's assessment.
no adverse event reported - we are to log Ped Pfizer vaccine with lot number that got administered October first after the recall came down concerning lot FL2757. told by manufacturer that dose was still viable but to still report.
Fever 104, Vomit x 2, shaking episode, talking in sleep, Fever from 2am 9 pm, C/0 neck pain when putting hair in ponytail, Does move neck-c/o mild headache 8/21/02
Body chills started at 11:00 pm day of vaccination, major headache started roughly 12:00 am day after vaccination. Chills ended roughly 9:00 am day after vaccination, Headache ended roughly 3:00 pm day after vaccination.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
mom states that p/vax pt devel a bump @ the site;next day it was larger but gradually subside but never went away;pt cont for weeks to act as if it hurt;took to PMD who referred to surgeon;surgeon dx area as sterile abscess & lanced it;
The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line. My friend  also has the same thing.; The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line. My friend  also has the same thing.; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID:  This case refers to friend. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), ILLNESS (non-serious) all with onset 13Jun2022, outcome "unknown" and all described as "The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line. My friend an NP also has the same thing." Additional information: I am an NP who had your 2 doses and one booster of COVID vaccine. The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line. My friend an NP also has the same thing. I think this happens more often than reported. I and others are very hesitant to get more vaccines and would like your scientists input. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200001516 Same reporter/ drug/ event for different patient;
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via (Pfizer Inc.) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. This report was non-serious.
Received first dose of Moderna vaccine on Friday 1/22   no acute reaction, no fevers or chills.  On Saturday afternoon noted "very dark yellow" urine, which persisted despite increasing water intake.  Sunday felt a little nauseated.   Monday came for previously scheduled visit with me and found to have elevated bilirubin and transaminases   No recent changes in meds.  Carpal tunnel surgery approximately 3 months ago.  No recent travel or unusual meals.
Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Tired) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tired). On 20-Mar-2021, HEADACHE (Headache) and FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified asthma inhaler.  No treatment information was provided.
Shortness of breath and joint pain,  since I got the shot. Use albuterol intermittently