chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was billed correctly for moderna spikevax vaccine. At the time to pull the vaccine, pfizer pediatric was pulled and incorrectly given to the patient at the time of vaccination.
Severe fatigue, nausea, vomiting. Note: this was the booster 8 months after original 2 dose regimen. Only mild fatigue during first 2 doses. Much worse fatigue with booster and nausea and vomiting were not present during first 2 doses.
pt recv vax; exp rash on stomach, genitals, under arms; to MD;
After receiving all vaccines client experienced a syncope episode. No more than 2 min. after vaccine 3rd min. Fainted for about 3 sec.
p/vax noted tongue swelling on 10/9/99;also noted tongue ulcers w/diff swallowing & speaking;saw dentist given antiviral & mouth rinse;sx improving;
Pt was waiting for discharge papers when she suddenly fell down on the floor. She was laid on her back, she was breathing, she had a pulse but she wasn't responding to questions, she appeared "dazed" for about 15-20 sec. She subseq. responded after some shaking, she said "she was dreaming". She gradually got up & went back to the room where she laid on the bed for 30 minutes. She said she "feels fine" & she was subsequently discharged.
Shingles outbreak on face, scalp and right eye approximately 2 weeks after first Pfizer shot. Went to doctor and got prescription of Valtrex and Zirgan for eye. Currently recovering.
Had shot and got shingles now/suspected vaccination failure; Have shingles now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient had the shot and had shingles now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Immediate pain at injection site which has lasted for 4 days to date. Pain was significant on 1st and second day and minimum, but still present on day 4. Lump at injection site of approximately 1/2"-3/4" in circumference which has lasted 4 days to date.  Started to decrease on day 3 but is still present on day 4. Bright red circle approximately 3"-4" around inject site lasting 3 days. I have photo on file.
Initial- bright red symptoms on right lower arm , one hour after injection.  Forty-five  minutes later, left arm inflamed .    No swelling or reddening of throat or tongue  .  Patient offered 2 caps  of 25mg generic  Benadryl  . She took one capsule  (Pt did not want to be drowsy ).  Kept the other capsule to use if symptoms did not subside or if needed  .  Patient  called her primary doctor. She said he advised her to go to urgent  care center. Patient left  to do so.  Next day, (04/30/22  ) patient  better, but said MD advised her to  rest for 3 to 4 days .   Not  aware of any other meds  prescribed .
Left arm is red, on side of arm; some swelling & pain pt received injection in afternoon and came back the next day with the symptoms.
Myalgia sweating, fatigue Narrative:  symptoms lasted 48 hours  Other Relevant History:
Severe Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 12:00 the patient experienced severe arm soreness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe arm soreness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
The site had localized swelling, about 1cm diameter. No erythema, no edema. The pt denied dyspnea or feelings of throat closing. No stridor, no wheezes. Medical provider evaluated patient, placed an ice pack on the injection site. He evaluated 10 minutes later w/ similar, stabilized results. Discharged pt w/ instructions to take an antihistamine if itchiness or swelling worsens. If dyspnea develops, instructed pt to call 911 or go to the ED immediately.
Received 2nd shot around 1:30pm,.  Approximately 12 hours after 2nd shot woke up shivering and having muscle cramps in legs and feet.  I had to actually get out of bed to try and relieve the cramping.    I was cold and muscles were cramping but with extra blankets  was able to fall back to sleep.  Woke up in the morning  feeling very sore with  muscle pain/aches.  Neck was so sore I could barely keep my head up.  My whole body hurt, had a bad headache and fever of 100.4 when I finally took it.  For the next 24 hours all I wanted to do was sleep.  When I woke up the following morning still had a slight headache that went away as day progressed.  Just thought you might want to hear about this.  Not sure what you do with this information but hope it is helpful.
Woke up 9/23/04 at 4AM complaining of headache and tenderness in occipital region. Tylenol relieved discomfort. Exam at public health office at 10AM 9/23/04 occipital region slightly enlarged. Pt referred to MD. 9/24/04 MD did not feel symptoms were related to vaccines.
Patient is a 56 year old female patient with a past medical history of hypothyroidism, gout, allergic rhinitis, ADHD, depression who presented to ED 8/27/2023 with complaints of COVID-19 exposure, fever, cough, shortness of breath, nausea/vomiting.  Tested positive for COVID-19.  Admitted for further workup/management.  Course is remarkable for:   COVID-19 virus infection Pneumonia due to COVID-19 CXR on admission showed suspected minimal infiltrate in RLL Since she is having pleuritic discomfort and D dimer is positive CT pulmonary arteries-no evidence of PE Continue IV Decadron Continue remdesivir 5 days Albuterol as needed, antitussive as needed Tylenol for pain and fever. blood cultures NGTD ESR CRP trending down Ferritin trending down   Depression Continue citalopram   Hypothyroidism Continue levothyroxine   GERD Continue PPI
Mother reports patient developed light red rash on Saturday 9/1/2016. Patient took more naps on Sunday and had a 100.0 fever on Monday. Patient has been eating less, but mother reports drinking normally and normal wet diapers.
Shaking 20 min after vaccination. She tool EXCEDRIN 2 hrs later and felt a little better.
Information has been received from a consumer concerning her daughter who on 18-FEB-2008 was vaccinated with a fourth dose of GARDASIL (Lot # unknown) by mistake. In July 2007, in August 2007, and in January 2008 the patient was vaccinated with the first, second, and third dose of GARDASIL (Lot #'s unknown), respectively. The patient experienced pain at the injection site after each dose. The consumer reported that "the patient experienced no adverse side effects as a result of this." Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/7/2008.  Information has been received from a consumer concerning her daughter who on 18-FEB-2008 was vaccinated with a fourth dose of GARDASIL (Lot # unknown) by mistake.  In July, 2007, in August 2007 and in January 2008 the patient was vaccinated with the first, second, and third dose of GARDASIL (Lot #'s unknown), respectively.  The patient experienced pain at the injection site after each dose.  Follow-up information received from a registered nurse included that on 29-JUN-2007, 11-SEP-2007, 02-JAN-2008, and 18-FEB-2008 the patient was vaccinated with the first, second, third, and fourth dose of GARDASIL (Lot #'s unknown).  The nurse also reported all patients complain about pain at the injection site after every dose".  The nurse comfirmed that the statement "all patients complain about pain at the injection site after every dose: was a generalized statement that the injection site pain "is not considered and event".  She stated that they ahve read the literature and understand this is an expected reaction.  They have begun to explain this to patients when they come in for the injection and make certain they sit still for 15 minutes following the injection to avoid possible fainting.  As it is a general statement, the nurse reported that the doctor would not be providing any specifics patient details.  There will be no additional information coming in from the office concerning this event.  Additional information is not expected.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA . Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Patient felt sick; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: Patient felt sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-SEP-2023 The reporter reported that the patient received Shingrix vaccine and experienced bad reaction and felt sick but there was no rash or other allergic reactions. The reporter asked for information about the efficacy of only one dose of Shingrix vaccine. The reporter could not provided more details since she mentioned this happened a while ago. The reporter consented to follow up.
This is a spontaneous report from a contactable nurse (patient reported for herself). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 11Jun2021 (at the age of 72-year-old) as dose 1, single for COVID-19 immunization. Medical history included multiple sclerosis from 1980 and ongoing, heart disease. The patient concomitant medications were not reported. The patient was not taking any medications routinely prior to the event being reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced first dose: sore arm/sore arm after the first dose on 12Jun2021 at 08:00 AM. Patient stated she did fine with the first injection, nothing except for a sore arm. It just lasted a day. AE does not require to visit emergency room, physician office. The patient does not have a positive test for SARS-CoV2. The patient does not have a SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized and not admitted to an intensive care unit. Reporter seriousness for first dose: sore arm was medically significant. Outcome of the event was unknown. Event relatedness for first dose: sore arm was related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious event Pain in extremity cannot be totally excluded. 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.
Starting about a week later after first shot on April 5th- Severe chest pain, heart palpitations, racing/pounding heart, shortness of breath, difficulty breathing, exacerbated by speaking and all forms of physical movement, worse when laying down. Emergency room visit on April 16th diagnosed with pericarditis. Followed up with Rheumatology and Cardiologist on April 20th-started colchicine and naproxen prescriptions and refrained from phsysical activity for one month, called out from work multiple days due to chest pain. Followed up again with cardiologist on June 4th for continued chest pain. Chest pain improved with treatment but continues to be mild to this day-June 23rd.
p/vax pt devel a rash;It was reported that MD did not see the pt & the isolates could not be collected;
Hospitalization: 12/16/2022 - 12/23/2022 (7 days) Presentation to the ED: diarrhea 24 HOURS with mild abdominal cramping.  COVID + date: 12/19/22 Treatment: NO TREATMENT SPECIFIC FOR COVID D/T NOT BEING HYPOXIC.  Discharge to: SNF  MODERNA 013M20A 2/18/2021 MODERNA 047A21A 3/22/2021 MODERNA 047C218 9/26/2021
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered as disability.
This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 21-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. It was reported that the "fluid came out; it leaked through the barrier Band-Aid". At the time of the report, the outcome of the adverse event was unknown. No product quality complaint (PQC) was involved. The causality between the adverse event and ZOSTAVAX was unknown. Additional information has been requested.
Patient reported tiredness, chills, tenderness, and no bump. She also complained of a green dot the size of a small freckle. She said it occurred after her first Covid-19 vaccine and has not resolved. It looks like a green dot tattoo. She said she is not having any side effects currently, minus the green dot which has not resolved yet.
feels tingling and coldness in her fingers and feet; feels tingling and coldness in her fingers and feet; This is a spontaneous report from a contactable nurse (patient).  This female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Caller stated that she started experiencing paresthesia a few hours after getting the vaccine. Mentioned that she feels tingling and coldness in her fingers and feet and wanted to know if this is normal or should be of concern. Caller wanted to know more information regarding patients who experienced paresthesia so she can provide information to her HCP to help them decide whether she can get next dose or not. Outcome was unknown. Information on the lot/batch number has been requested.
Adult dose vaccine given to pediatric patient. Patient received .5mL of Afluria Quad instead of .25mL
again struggling with nausea and diarrhea; again struggling with nausea and diarrhea; nausea and diarrhea has been on and off; nausea and diarrhea has been on and off; redness at the lower deltoid attachment/two silver dollar sized red rashes at the lower deltoid attachment; left arm went back to being "a little sore"; left arm was "pretty sore"; left arm was "a little sore"; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (left arm was "a little sore"), PAIN IN EXTREMITY (left arm was "pretty sore"), PAIN IN EXTREMITY (left arm went back to being "a little sore"), DIARRHOEA (nausea and diarrhea has been on and off) and DIARRHOEA (again struggling with nausea and diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm was "a little sore"). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm was "pretty sore"). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm went back to being "a little sore"). On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the lower deltoid attachment/two silver dollar sized red rashes at the lower deltoid attachment). On 20-Jan-2021, the patient experienced DIARRHOEA (nausea and diarrhea has been on and off) and NAUSEA (nausea and diarrhea has been on and off). On 03-Feb-2021, the patient experienced DIARRHOEA (again struggling with nausea and diarrhea) and NAUSEA (again struggling with nausea and diarrhea). At the time of the report, PAIN IN EXTREMITY (left arm was "a little sore"), PAIN IN EXTREMITY (left arm was "pretty sore"), PAIN IN EXTREMITY (left arm went back to being "a little sore"), DIARRHOEA (nausea and diarrhea has been on and off), DIARRHOEA (again struggling with nausea and diarrhea), VACCINATION SITE ERYTHEMA (redness at the lower deltoid attachment/two silver dollar sized red rashes at the lower deltoid attachment), NAUSEA (nausea and diarrhea has been on and off) and NAUSEA (again struggling with nausea and diarrhea) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Mom noticed around 7:00 AM this morning that (R) upper arm was very red and very swollen. Redness about 4 inches on diameter and arm is very swollen compared to (L) arm. Child says (R) upper arm hurts. Instructed mom to take child to PCP for evaluation. Dr. told parent to give BENADRYL to child at home. Warm soaks and TYLENOL. Letter from doctor stating no more tetanus vaccines.
pt recvd 2nd dose of vax & exp severe h/a for 3 days as well as weakness, fatigue & local tenderness @ inject site; treatment none;
patient received an expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.
tiredness / fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness / fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DILTIAZEM for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness / fatigue). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-106361 (Patient Link).