chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 13Dec2021 at 09:00 (Lot number: unknown) at the age of 26 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Migraines"; NAUSEA (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Vomiting"; DECREASED APPETITE (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Loss of appetite"; PYREXIA (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, nausea, vomiting, decreased appetite and pyrexia. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HEADACHE, TIRENESS, MUSCLE PAIN, MILD FEVER (99.5 F), CHILLS, TYLENOL OR IBUPROFEN, MONITOR TEMPERATURE
Rt upper arm- erythema edema and itching. Tx: Benadryl 25 mg PO every 6 hours.
12/20/21 pt seen at Medical Center ED with c/o cough and diarrhea x 2days; found to be positive for COVID; no O2 supplementation needed; was dc'd to home; 1/9/22 pt presents to ED in Medical Center with c/o cough, diarrhea, nausea and chest pain; hypoxic (O2 sats 65% on RA); O2 supplementation; admitted; worsening respiratory and renal failure; family requested desire for intubation but DNR; on 1/21/22 pt became tachypneic, but saturating reasonably well; became pulseless and passed away in the hospital; med records and death certificate sent per VAERS request
Pregnant Received 2 doses of vaccine; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant Received 2 doses of vaccine) in a 38-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Obesity in 2011. Concurrent medical conditions included Asthma, Hypertension since 2016, Hypothyroidism since 2015 and Pregnancy (Due date-01-09-2021) since 31-Dec-2020. Concomitant products included LEVOTHYROXINE, VITAMIN D NOS, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT inhaler), NIFEDIPINE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA) and HYDRALAZINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 25-Nov-2020 and the estimated date of delivery was 01-Sep-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant Received 2 doses of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant Received 2 doses of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Pregnancy test positive: positive (Positive) positive.         no treatment provided.  Estimated date of conception was 07 Dec 2021.
315PM vax given; 317 urticaria @ inject site; 50mm area of red rashy area; tongue tingling throat scratchy; 415PM no further react; throat itchiness; 28OCT93 855AM pt report arm sore, difficult sleeping, rash, painful area;
PATIENT (DOB XX/XX/XXXX) REPORTED TO THE PHARMACY TODAY WITH A RED CIRCLE AROUND THE AREA WHERE SHE RECEIVED HER SECOND SHINGRIX VACCINATION. PATIENT WAS INFORMED THAT THIS WAS NOT AN UNUSUAL REACTION, AND THAT APPLYING A COLD PACK WOULD HELP QUITE A BIT. PATIENT WAS ALSO INFORMED TO KEEP AN EYE ON THE REACTION AND IF IT SPREADS, LET US AND HER PRESCRIBER KNOW. PATIENT EXPRESSED UNDERSTANDING AND THANKED ME FOR THE ADVICE OF THE COLD PACK. WILL FOLLOW UP NEXT WEEK.
Initial and follow up information has been received from a medical assistant and a physician concerning a 16 year old female patient who was vaccinated with GARDASIL dose 1 (lot # 659055/0560X) on 10-AUG-2009 and dose 2 (lot # 666931/0337Z) on 01-MAR-2011. No other vaccines administered on 01-MAR-2011, the date of event. The medical assistant reported that on 01-MAR-2011 the patient became disoriented and felt sick immediately after her second vaccination with GARDASIL. She was unable to recognize her father and could not see or hear anyone around her. She rested for about 20 minutes and was then fine. The physician described the patient as becoming dizzy and disoriented, she was weak and had a crying episode. At first, the physician thought the patient was hyperventilating so gave her a paper bag to breathe in; it was also suspected that the patient might be having a vasovagal episode; vital signs were normal (blood pressure was normal); there was no blindness or hearing loss, just a feeling that she was going to pass out - which the patient did not do. The patient was recovered from disoriented, felt sick and unable to recognize her father on 01-MAR-2011. The outcome of other events was unknown. No further information is available.
Taste rubber/vanilla milk; Vertigo prone sleeping; High blood pressure; Left arm sore; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en 6206) via an unspecified route of administration in the left arm on 06Mar2021 at 15:00 (at the age of 64-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removed on 11Feb2021. The patient had no known allergies. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 07Mar2021 at 04:00, the patient experienced taste rubber/vanilla milk, vertigo prone sleeping, high blood pressure and left arm sore 5 days. Therapeutic measure was taken as result of event vertigo and included treatment with meclizine (MANUFACTURER UNKNOWN). The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of taste rubber/vanilla milk, vertigo prone sleeping, high blood pressure and left arm sore were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Second dose of Pfizer(EW0191) given at 7:40 am. Symptoms started at 8:08 am. Patient had complaint of slight blurry vision, itchiness on arm, lips. Patient anxious. Patient was given 25 mg Benadryl at 8:10 am Vital signs BP 120/65,  P 110, R 18, alert and oriented x4. Patient waited 30 minutes. Upon leaving patient felt better, itching and blurry vision gone. No further interventions done.
My son informed me that his arm was still hurting where he got the injection. There was an area below the injection site that was warm to touch, red and painful. He was diagnosed with cellulitis and prescribed antibiotics.
This spontaneous report was received from a pharmacist and refers to a 63 year old female patient with no pertinent medical history, concomitant therapies or drug reactions or allergies. On 31-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, for prophylaxis, lot # M039453 with expiration date of 19-DEC-2017 (dose, route and frequency were not reported). Other suspect therapies included sterile diluent (manufacturer unknown). On 03-NOV-2017, the patient experienced a raised six inch wide area around injection site and was warm to touch after being vaccinated with ZOSTAVAX. The patient did not perform laboratory diagnostic studies, she did not present significant disability or incapacity, she did not need hospitalization and the events were not life threatening. The outcome of injection site mass and injection site warmth was unknown. The causality between injection site mass and injection site warmth with ZOSTAVAX was not reported.
Received flu vaccine and resulted in severe Left shoulder pain and limited ROM post vaccine and remains after 2 weeks
Patient stated that she was tasting saline, has a burning that feels like it is in her esophagus, burning behind the breast, and soreness in her arm.  She called her primary provider and they wanted her to go to the emergency room.  I called her to follow up on how she was doing and she said that she is unable to go to the ER today.  She said that she does not have someone to watch her daughter and will go to the ER tomorrow morning.
In less than two hours after vaccination, went into severe hypoglycemic condition, resulting in highly unusual behavior, but not unconsciousness, noticed by several people.  Orange juice consumed, and condition improved and recovery complete.
Gradual flushing of face and neck. Each following day increased redness, itch and by 4th day hives apparent. These extended onto upper chest. I did not connect this to the vaccine. I applied topical cortisone which brought down the redness but not the hives. Very little change in hives which seemed to increase. Finally saw MD on Sunday the 24th of June. He ordered a cortisone injection IM and I started a methylprednisolone/MEDROL 4mg DOSEPAK. By this time the itching and hives had extended to behind my ears. One day into meds, the angry redness is reduced, the itching remains but is diminishing, the epicenter remains my chin and throat.
Myalgia, Weakness. Chills & stomach upset that have resolved. Narrative:
Fever above 100 degrees Fahrenheit for 24 hours Sore arm at injection site for 72 hours Significant fatigue for 48 hours
Patient was noted to have a red rash starting under his nose that extended down his neck and to his chest and some redness on his back.  5 days later small pustules appeared on his face and neck but, not on his chest or back.
Information has been received from a nurse concerning a female (age not reported) with a history of convulsion who on approximately 25-OCT-2007 "a week ago" was vaccinated with Gardasil (lot# unknown). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA). Other concomitant therapy included divalproex sodium (DEPAKOTE) to control seizures. The nurse reported that the patient had a seizure within 15 minutes after receiving the Gardasil. It was unknown if the patient had sought medical attention. On an unspecified date the patient had recovered from the seizure. There was no additional information. Follow-up information was received that on an unspecified date the patient had a seizure 2 days after the vaccination of Gardasil. No further information was given. Upon internal review, seizure is considered to be an other medical event (OME). Additional information has been requested.
knot midway down the arm; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (knot midway down the arm) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m23aa) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE MASS (knot midway down the arm) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INJECTION SITE MASS (knot midway down the arm) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient c/o slight nausea immediately after receiving injection (11:45 am 3/13/08). This passed in 5 minutes and patient felt fine and V.S. were stable. Patient c/o red blotches on neck, upper chest and (R) shoulder approximately 2 1/2 hrs later. V.S. stable. No other complaints.
Chills; Sweating; Muscle aches; Fatigue; Possible start of Migraine
First was a continuing headache that started Saturday..  it worsened slowly.  Then, a Rash  appeared in inner arm opposite the shot arm between the elbow and armpit in the evening.  It was itchy.  At 5 AM the next morning - I started vomiting...  After 5 bouts of that about 3 hours apart, it stopped at 9 PM.  The rash had faded but did not leave until Friday evening , finishing with an itchy spot around the elbow.  - Had chicken pox as a child ..... - Did not experience congestion or diarrhea.
pt recvd vax; pt exp itching; when 2nd dose admin same symptoms occured 1 & 1/2 hr following vax;
He suddenly became sick; pain; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient suddenly became sick on 30Jan2021 and tested positive for COVID on 02Feb2021. He took some prednisone and some other medications for pain. Given his situation, he was given an infusion of antibodies by his HCP. Then, he was advised to stay at home for an 8-9 day-quarantine. Now, he wondered known when he should be able to take his next dose of the vaccine sometime in May2021, if he should take it at all. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a 42-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Nov-2011, two patients received the expired FLUMIST. The product expired on 20-Nov-2011. On 21-Nov-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (then received a Moderna Covid-19 50mcg  booster dose 6 months after they had received the second full dose of the Moderna Primary Series) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (then received a Moderna Covid-19 50mcg booster dose 6 months after they had received the second full dose of the Moderna Primary Series). At the time of the report, ACCIDENTAL UNDERDOSE (then received a Moderna Covid-19 50mcg  booster dose 6 months after they had received the second full dose of the Moderna Primary Series) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was received two 100 mcg doses of the primary series of the Moderna Covid-19 vaccine spaced properly apart by 28 days. No concomitant medications were provided. No treatment medications were provided.
Pain radiation from injection site down arm to elbow, extreme headache (migraine like), nausea staring 24 hours after injection, no solids  only liquid.
Temp 100.7 degrees Fahrenheit and chills lasting for less than 7 hours; Temp 100.7 degrees Fahrenheit and chills lasting for less than 7 hours; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable Nurse(patient). The 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:el0140), intramuscular at Left arm on 18Dec2020 11:15 AM at single dose(dose number was 1) for COVID-19 immunization in hospital.  Medical history included ongoing allergy to treenuts. She was not pregnant. The patient's concomitant medications were not reported. There was no other vaccine in four weeks nor other medications in two weeks. There was no covid prior vaccination. The patient experienced temp 100.7 degrees fahrenheit and chills lasting for less than 7 hours on 19Dec2020 12:00 AM. There was no treatment. Lab data included body temperature: 100.7 fahrenheit on 19Dec2020, Covid-19 PCR (Covid test type post vaccination=Nasal Swab): negative on 22Dec2020.  Outcome of events was recovered in Dec2020. Case was assessed as non-serious.
Patient was instructed to wait in office 15 min after vaccines, patient has seizures in office after vaccine.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jan2021, the patient began to experience headaches, fatigue, cough and chest congestion. Then on 02Feb2021, the patient had tested positive for COVID-19. The outcome of the event, 'tested positive for COVID-19', was unknown. The patient was asking if she should get the second dose of vaccination or should wait three months post-infection; or should she begin the process again of taking the first and second dose; or should refrain completely from getting further vaccine doses.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The reporter stated that a patient was administered the first dose in the series of three GARDASIL 9, intramuscularly, on 05-MAY-2016, and the second dose of GARDASIL 9 was administered earlier than the recommended two month interval on 01-JUL-2016. The primary reporter confirmed that the third dose of GARDASIL 9 was not administered. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
The pt experienced a fever of 102 and a rash that lasted approximately 5 days.
The patient described shoulder pain intensifying a couple days after vaccine administration.  The pain has been around the injection site and has continued for over a week.  The patient has not received medical attention for this issue.
Fever chills nausea  which went away next day however now I have no sense of taste  or smell
redness & soreness lt arm, 5cmX5cm; redness w/heat; Rx pred
Admitted 8/2-8/6 Moderna on 2/11/21 and 3/12/21. Positive on 8/3
Felt like fainting; Nervous after the second shot; Dizzy after first and second shot; Rhabdomyolysis; heart rate increased; Malaise; Tired with normal activity after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Emotional distress (upset about his parents) on 27-Apr-2021.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizzy after first and second shot) and FATIGUE (Tired with normal activity after the second shot). April 2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), HEART RATE INCREASED (heart rate increased) and MALAISE (Malaise). On 27-Apr-2021, the patient experienced PRESYNCOPE (Felt like fainting) and NERVOUSNESS (Nervous after the second shot). The patient was treated with ALPRAZOLAM on 27-Apr-2021 for Anxiety, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like fainting), NERVOUSNESS (Nervous after the second shot), DIZZINESS (Dizzy after first and second shot), RHABDOMYOLYSIS (Rhabdomyolysis), HEART RATE INCREASED (heart rate increased), MALAISE (Malaise) and FATIGUE (Tired with normal activity after the second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 148/90 (High) Blood pressure at rest was 148/90 for the entire day. On 27-Apr-2021, Heart rate: 140 (High) Felt his heart  in chest beating fast 140.        Concomitant product information was not provided.  On 27-Apr-2021, the patient visited an emergency room (ER) where he was prescribed an anxiety medication.   The patient reported he thought he might have myocarditis after hearing about it on the news.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-243062 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with the doses of improperly RECOMBIVAX HB (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.