chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for an 83-year-old female patient (Reporters mother) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Jan2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. In Jan2021, after 2 or 3 days, the patient experienced headache and chills (non-serious events). The outcome of both the event was reported as unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Reaction to DTaP shot, was seen in ER 10/02/06, seen in office 10/3/06.
Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no known drug allergies, who on 12-FEB-2009 was vaccinated with the first dose of GARDASIL (lot # 661046/0546X) 0.5ml  intramuscularly. There was no concomitant medication. On approximately 17-FEB-2009, "within the last week or two, the patient developed generalized joint pain that was migratory, and pain at the unspecified arm and was not able to lift that arm, which has improved. Patient also developed generalized body pain and leg pain.; Patient sought medical attention by calling the office. No lab diagnostic studies were performed. At the time of this report the patient had not yet recovered. Additional information has been requested
Headache, Myalgia, Fever, numbness to left foot for 30 minutes duration after administration Narrative:
Patient was erroneously vaccinated with Typhoid.  No know adverse reaction has occurred at this time.
Shortness of breath/ out of breath walking around the house; Chest tightness /Feel a constant pressure on chest.; Shortness of breath and chest tightness with fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:  EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included vedolizumab (ENTYVIO) for an unknown indication from an unknown start date and unknown if ongoing. On 17Apr2021 at 12:30, immediately after receiving the vaccine, the patient had shortness of breath and chest tightness with fatigue. To date on 23Apr2021, the symptoms had not subsided. As on 23Apr2021, the patient had tested negative for COVID-19. The patient's vitals were fine. However, the patient was out of breath walking around the house and felt a constant pressure on the chest. The patient was physically active and normally worked out approximately 5 days a week. Being short of breath, with chest tightness was not something the patient was accustomed to. The patient had been assessed by a medical professional and did not have any other symptoms or fluid in my lungs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 23Apr2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events shortness of breath, chest tightness with fatigue, out of breath walking around the house and felt a constant pressure on the chest was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
HEADACHE; CHILLS; FEVER 100; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) dose was not reported, administered on 07-MAR-2021 04:00 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced headache, chills, and fever 100. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills and fever 100 was not reported. This report was non-serious.
I got hives all down my legs, then started getting them on chest. Took benedryl and that did help. Elevated heart rate
intense dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (intense dizziness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE and PRAVASTATIN for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (intense dizziness). On 26-Feb-2021, DIZZINESS (intense dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the patient was taking blood pressure medicine
Increase BP, pulse rate, dry mouth, dizziness, redness above site, rapid breathing, anxiety. Pt sent to urgent care facility and was given Zyrtec.  Instructed to go to emergency room if complication occurs (statement per pt).
pt recv vax 21AUG95 & 12OCT95 pt had a negative titer;
Upon vaccination, patient was visibly upset initially because of the pain of vaccination, but then began to feel dizzy.  Her face was pale with a slight bluish tinge of lips.  She laid down on the floor and within about 10 seconds, began to regain normal color in face/lips.  She was given apple juice and crackers and was instructed to sit with pulse ox for about 20 minutes.  She reports having not eaten prior.  She felt much better after almost immediately after laying down and throughout observation period.
This initial non-serious spontaneous case, was received from a pharmacist, concerning a patient of unspecified age and gender. On an unspecified date, the patient received influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient experienced unspecified reaction. No further information was available.
After the first injection of the Moderna vaccine(03/23/21) covid- 19, I started having irregular menstrual cycles that consist of heavier bleeding and last for an abnormal amount of time some lasting 2+ weeks or more. I've seen some other reports of this so that is why I linked the potential side effect to the vaccine.
As I have been trying to explain for several months, this Moderna Vaccine seems to have aggravated avascular necrosis, which has accelerated in my body since vaccination. However, this is NOT intended as a common side-effect. This seems to apply ONLY to me. Since this disease is progressive, and cannot be corrected, this report is only intended as a form of interest, and not something requiring some immediate modifications to the vaccines.  However - I would also like to let the CDC know that I have developed a much better vaccine, and a methodology which is light-years ahead of anything now available. So, if you can connect me with someone at the CDC, who will listen, I can explain and provide proof.   BUT - please be notified that filing this report of reaction to the current vaccine is NOT intended surreptitiously, but only as a side-note to what I experienced, and which I thought the CDC should know.
local erythema w/mild induration lt arm 15x77 cm; no tx;
Temperature Excursion; Initial Report Received on 05-Jan-2023 and 09-Jan-2023  A medical assistant and a pharmacy purchaser reported that a 46-year-old female patient (race and ethnicity unknown) [Patient 2] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 23-Dec-2022, there was a power outage at 04:00 AM at the health center. There was no backup generator to the vaccine refrigerator. When the medical assistants came into work, they heard the vaccine refrigerator's alarm go off. The refrigerator was warm with a temperature of 54.5°F at 06:45 AM. All the vaccines were removed and put into coolers with ice. Pharmacy was notified, and all the vaccines affected by the power outage were counted.   On 03-Jan-2023, 12 days later, the patient received a dose of HEPLISAV-B (Lot # 938794, expiration date 09-Oct-2023, and NDC # 43528-003-01) in the right deltoid (route not reported) by a medical assistant. It was discovered the next day on 04-Jan-2023 that a couple of boxes were missed being removed after the power outage, and the patient had received the HEPLISAV-B vaccine that had the temperature excursion of 54.5°F for 2 hours and 45 minutes.  No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Post vax, on 11/20/2000, the patient was exposed to a child who had chicken pox at school. On 11/11/2000 the patient was seen in her physician's office and chicken pox was confirmed by the physician. The patient then developed 30 red spots with blisters on top on numerous areas of her body. The patient had a fever of 102F. The patient was treated with Benadryl as needed for the itching, Aveeno Bath and calamine lotion. In November 2000 the patient also had a vaginal yeast infection and was treated with Diflucan. On 12/08/2000 the patient recovered. No further details were provided.
51 year old male client with previous negative lab titer for Mumps advised by PCP to get MMR vaccine. On 5-21-12 client seen in IZ clinic and given MMR vaccine in left arm subcutaneous. Client called IZ clinic on 5-29-12 and stated he has experienced "minor tingling and numbness in his left shoulder, arm and hand that started on 5-23-12". As of today 5-29-12 client states "feel constant pins and needles in left shoulder, arm and hand, with pain level of 4/10 with the use of the left arm to pick up objects". Client states he called PCP 5-29-12 prior to notifying IZ clinic and spoke to someone in the office who told him "it sounds like a nerve thing". He states he was not seen or offered to come to be seen by PCP. Advised client if condition worsens or doesn't improve to call PCP again.
Narrative: He experienced diarrhea after the 1st vaccination. This started sometime that evening or the next day and spontaneously resolved within 24 hours. No therapies were tried and there was no associated abodminal cramping, nausea or vomiting. He denies other common adverse effects and does not have any food intolerances/sensitivities. No one else around him had a similar issue that he was aware of.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in right leg, in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left leg and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN, start date: 01Jan2022, stop date: 22Nov2022; AMLODIPINE, start date: Jan2022, stop date: Nov2022; ROSUVASTATIN, start date: Jan2022, stop date: Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovering" and all described as "Treatment of COVID-19". 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.
Information has been received from a nurse concerning her granddaughter who in May 2005 ("4 years ago") was vaccinated with her initial dose of MUMPS virus vaccine live (Jeryl Lynn). After receiving the vaccine, the patient's face became swollen and she experienced a rash. Subsequently, the patient recovered. The patient sought medical attention via contacting with physician. The nurse noted that it was reported at the time. No further information is available.
This report describes pertussis in an approximately one year old female who received either DTP (brand unknown) or DTaP (brand unknown). Approximately, "seven year ago" the vaccinee received her first IM leg dose of DTP (brand unknown) or DTaP (brand unknown) Subsequently, "seven year ago", she cried and developed a fever. On an unspeciifed date, the vaccinee received her second IM leg dose of DTP (brand unknown) or DTaP (brand unknown). Subsequently, the vaccines reportedly developed pertussis. On unspecified dates, the vaccine received her third and fourth day IM leg doses of DTP (brand Unknown) or DTaP (brand Unknown). Following dose 4, the vaccinee cried and developed a fever. A doctor visit was required. As of 06/18/01, the outcome of the events was resolved.
No adverse events listed - patient was exposed and tested positive to COVID  04/05/21 1439  COVID-19 (SARS CoV-2,RNA Molecular Amplification)  Collected: 04/05/21 0845 | Final result | Specimen: Swab from Nares   COVID-19 SARS-CoV-2 Overall Result DetectedCritical
OBSTRUCTIVE SLEEP APNEA 12/18/2021  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient's mother reports that on 10/18/18 (the night that FLUARIX vaccine was given) that the patient woke up around 2:00 screaming and grasping at the air. Patient reported seeing "pink stuff flying in the room" and was grabbing at things coming out of her hands." She felt warm to touch and mother gave Tylenol but did not take temperature. Since that date, patient has been fearful of bedtime and naptime. She will occasionally swing at things in the air or grasp at her hands. Patient had a second occurance of waking from sleep screaming and seeing "blue stuff flying in the air" on 10/23/18.
Information has been received from a physician concerning a 49-year-old female with a latex, penicillin and codeine allergy who on 19-OCT-2007 was vaccinated subcutaneously in the left arm with a 0.5 milliliter dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included DEPAKOTE, temazepam, lithium acetate, LEVOXYL, lisinopril (MSD) and an unspecified antihypertensive. On 22-OCT-2007, the right side of the patient's neck became swollen and painful. The patient was examined on 02-Nov-2007 and diagnosed with parotitis. The patient's blood titer for immunity to measles, mumps  and rubella was measured before the vaccine was administered and had positive antibodies for measles and rubella (titer level unspecified). The parotitis persists. No product quality complaint was involved. Follow-up information has been received concerning a female with neck and back pain, an unspecified skin condition and a history of thyroid cancer. It was reported that the patient is not allergic to gelatin and neomycin. The patient was vaccinated at 11:07 AM at an employee health clinic in the left upper arm with a firs dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# "02034"). There was no illness at the time of vaccination. Three to four days after the vaccination (previously reported as 22-OCT-2007) the patient developed "tender, firm, diffuse (2'X2") soft tissue swollen nodules right ear lobule on the side of the neck." It was tender and firm. There was no rash, no cervical adenopathy or fever. On 02-Nov-2007, the patients blood titer for immunity to mumps was positive. The outcome is reported as recovered, slowly returning to normal. The reporter considered parotitis to be persistent or significantly disabling. Follow-up information received on 03-JAN-2008 from a physician indicated that patient was no longer disabled and had recovered (previously reported as disabling). He stated the patient reported that sometimes the parotid gland swells off and on while eating. The physician stated that he was not sure if the parotitis or an obstruction of the parotid gland. He referred the patient to his primary care physician. Additional information is not expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-FEB-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In December 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed acyclovir for management of her painful symptoms. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
4th to 6th day after immunizations, temp 101. 7th to 10th day after immunizations, temp 104-105. No evaluation or treatment sought during this time. Mom reported fever and resolution on 07/19/2006.
Patient states that she was not able to form her words or speak the day after vaccination.  She states that the event eventually subsided and she did not call her doctor or wanted her doctor to be notified since she was ok.  Lasted 10 minutes.
patient had the second dose a month ago and showed negative antibody tests; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for 2 patients. This is 1st of 2 reports.   A patient of unspecified age and gender received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the second dose a month ago and showed negative antibody tests on an unspecified date (also reported as "now"). The reporter wanted to know if it was normal. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273877 same reporter, product, and event; different patient
Approximately 10 minutes after vaccine, while awaiting in observation patient started to have convulsions and was unresponsive for approximately 10-15 seconds then spontaneously recovered. States that he has had similar episodes after other vaccines and blood draws in the past. Vitals remained stable. Patient was transferred to the ED by EMS.
ABRUPT BEHAVIOR CHANGE AFTER VACCINE, WOULD NOT SLEEP SIGNIFICANT INCREASE IN ACTIVITY AFTER VACCINE
This spontaneous report as received from a consumer refers to her 11 week old son. The patient's pertinent medical history was none. On 14-AUG-2015, the patient was vaccinated with first dose of ROTATEQ via oral route. Concomitant medications were none. On 15-AUG-2015, the patient experienced bloody stools. On 30-SEP-2015, the patient was vaccinated with second dose of ROTATEQ. The patient had bloody stools on 30-SEP-2015 and continued to have bloody stools each day until 05-OCT-2015 (unknown if recovered). The patient's mother had the stools tested and the results indicated that the patient had a dairy protein allergy. The patient sought medical attention with the physician and no treatment was provided for the events. The outcome of the events was unknown. The relatedness of the events with ROTATEQ was not reported. Additional information is not expected as the reporter did not wish to be contacted.
Reaction I became I felt sore and swollen from my arm pit to my breast. My Lymph nodes in arm pit also started swelling. It went away about 10 days later.
Received 4th dose of Pfizer on 04/02/2022, then started feeling bad on 06/27/2022 and thought it was allergies. Started feeling worse as days went by so I took home test on 06/28/2022 and tested positive. Had a telemedicine appt on 06/29/2022. Was prescribed Paxlovid. Feeling better now on 7/7/2022.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient. The patient's medical history included Shingles on an unspecified date before vaccination with ZOSTAVAX. The patient has none drug reactions. On an unspecified date in 2015 (reported as a "year ago"), the patient was vaccinated with ZOSTAVAX (dosage, dose number, route of administration, lot number and expiration date were not provided). Concomitant therapies included lisinopril (manufacturer unknown), estradiol (manufacturer unknown) and cyanocobalamin (manufacturer unknown). On 05-JUN-2016 (reported as a day or two before 07-JUN-2016), the patient developed shingles again. It was also reported that the patient sought for medical attention by visiting the physician. The treatment given for shingles included valacyclovir. Additionally, it was reported that no intervention to prevent a serious criteria was necessary, that shingles was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of Shingles was reported as not recovered. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.