chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inability to concentrate comprehend new data or apply critical thinking; forgetfulness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 26Apr2021 at 09:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included degenerative joint disease in lumbar spine. The patient had no known allergies to medications, food or other products. 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. Concomitant medications included gabapentin 300mg per night (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date if unknown if ongoing. On 27Apr2021 at 07:00, the patient experienced inability to concentrate, comprehend new data, or apply critical thinking and forgetfulness. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events inability to concentrate, comprehend new data, or apply critical thinking and forgetfulness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Flu like symptoms including but not limited to fever, aches, sweating, dizziness.  Resulted in fainting and falling,  proceeded to faint multiple times - lost all bodily functions, eyes rolled in back of head multiple times and 911. Did get back to ability to get home but now repeats herself more than before and seemed to have lost some mental capacity till Wednesday March 10 / she now is better but scared to do anything on her own as fearing issues again
At 5:00 pm I started to have severe cold chills. I then developed a fever of 102.2 at 10 pm. I had severe nausea, body and muscle ache through the night. My fever spiked as high as 103.5 several times during the first night. I took 600 mg of ibuprofen and it did bring it down.  All symptoms continued through out the next day 04.09.21.  About 2 am on 4.10.21 I woke up and felt much better and that continued through out the day. Sunday 4.11.21 I started experience nausea again with slight fever of 101 no chills. I have since developed some nausea in the following days but no other symptoms.
This spontaneous report was received from a pharmacist via a company representative refers to a 60 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # and expiry unknown). The company representative read in the newspaper dated 14-MAY-2015, that was released on 13-MAY-2015, that a patient passed away on 11-MAY-2015, because of "complications due to a disseminated zoster virus". The representative stated that his wife overheard some unspecified individuals discussing the patient's death and mentioned that the patient had received one dose of ZOSTAVAX. Another company representative reported that a pharmacist had reported to him that the same patient had died after receiving the ZOSTAVAX. Causality of event was not reported. Additional information has been requested.
I had my vaccination on 10/26/2021. In 06/2022 I started to experience a sore throat fatigue and lost my voice for about a week with a low grade fever. I did test COVID-19 Positive in 06/2022. After 48 hours I started to experience a cough that has lingered since and is still present on 03/28/2023. I was prescribed an allergy medication and an increase on my existing allergy medication dosage.  I was put on a steroid Prednisone for a couple of days in 06/2022.  I still have the cough and fatigue on 03/28/2023.
Initial follow-up information has been received from a physician concerning a 10 year old male student with no pre-existing allergies, birth defects or medical conditions who was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # reported as 05404) SC in left arm on 05-SEP-2003. His second dose was received on 05-AUG-2008. There was no illness at the time of vaccination. On 23-AUG-2008 the patient developed mild chickenpox on his torso. The patient was seen at physician's office on 09-SEP-2008 and there were hardly any spots visible. There were no relevant diagnostic tests performed. He recovered on 09-SEP-2008. No further information is available.
About 10-12 minutes following dose, she came up to the counter and said her throat felt funny. I had her sit down and she said that her arm started tingling and it moved to her (upper) chest and then to her throat.  She was holding on to her throat. We called 911 and I administered a dose of epinephrine. In about 3 minutes she said it was starting to feel better.  EMS came about 5 minutes later and took over.  I spoke to her at 130pm and she said that she is ok and had left the emergency room.
BODY ACHES, FEVER 101, CHILLS, VOMITING, NAUSEA, DIARRHEA
MOM STATES THAT CHILDS RIGHT ANKLE AND FOOT SWELLED AFTER THE INJECTION.  SWELLING DID NOT EXTEND UP LEG.    UPON EXAMINATION, PATIENT NO LONGER HAD SWELLING.
A lot of upper respiratory mucous congestion coughing chills and muscle aches. The next day I took a home COVID-19 test which was immediately positive. I called my Doctor and he prescribed Pacxlovid for me and I noticed it was for five days as it was the reduced dosage. I started to get better about the third after starting my medication. I completed the course of medication and was feeling pretty good and retested and had a negative Covid test. Then two days later my symptoms returned almost as bad as previous, on the fourth day of this about ten days out I tested positive again foe COVID-19. A second tele visit regarding the rebound and the decision was no more Pacxlovid so I was prescribed Medrol dose Pak in case my asthma got worse but I never took it. I was tired for about a week and tested again which this time it was negative. I am now I am fully recovered.
patient tested covid positive by pcr on 5/22/2021, asymptomatic, tested routine for surgery
Covid arm...red..hot..swollen..headache. nauseous .vomiting. fatigue
I administered DTaP, MMR, IPV and a TB skin test on 8/19/03. On Thursday 9/28 mom reported a red macular spot had appeared the morning of 9/27 on child's right upper arm. She brought child in 9/28 because area was getting bigger. Irregular elongated lacey looking area across upper right arm at bottom of right deltoid. Child had been back in my office on 9/21 to have TB test read and reported no symptoms of any type side effect from the immunizations. Mom stated child did have hives once before but she didn't know why. I told her I didn't think it had anything to do with DTaP injection but it was an unusual looking hive and only one area. She did take child to local PA. Mom told me later that PA said it was a hive but didn't think it had any connection with immunization because it was much lower than where I gave DTaP at.
This spontaneous report was received from a registered nurse and refers to a 19 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
20SEP91 t102.8 coughing/nasal exudates pulling @ lt ear; dx LOM rx Suprax susp;
Booster shot. First was J and J. No adverse effects from that one. I have had slight Tinnitus over the years. About a week and a half to two weeks after receiving Moderna?s my Tinnitus  increased exponentially. I used to only notice it when in a quiet room such as going to sleep, now it?s constant and extremely loud. I hear it over everyday sounds.  This is occurring in both ears. Went to an ENT hoping maybe wax buildup was to blame, but removal of some from the right ear has not remedied it.
Narrative:  COVID infection following COVID vaccine series 0430 Janssen, dose #1 08/07 pt cc: chills, cough, fever, myalgias, exposure: unknown 08/09 COVID swab, result: detected 08/11 - 08/16 symptoms continue 08/10 SARS-COV-2 LINEAGE B.1.617.2 08/10 SARS-COV-2 CLADE 21A DELTA
Due to error in name spelling in state immunization registry, we did not find the clients information in the system indicating he already received 2 prior doses of the Pfizer vaccine in April and May. This was his 3rd dose of the COVID-19 vaccine and a different one than he originally received.  Called to verify information and after some questioning, patient knew was he was doing and thought a booster was fine. He had no adverse effects from his 3rd dose and feels just fine per his report.
increased shortness of breath; dizziness; This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number: EC-2021-087780), for bnt162b2.   A 75-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 14Jan2021 to an unspecified date at 14 mg daily for an unspecified indication; levothyroxine sodium, via an unspecified route of administration from an unknown date to an unknown date at 75 mcg once daily for an unspecified indication. Medical history included endometrial carcinoma as diagnosis C54.1, small bowel obstructions. The patient's concomitant medications were not reported. The patient previously took keytruda. Patient received first COVID vaccine this week and experience dizziness for 24 hours but has since resolved. Scheduled to receive second vaccine on 12Mar2021. Noted with increased shortness of breath with activity lasting longer than 10-15 minutes. Patient believe this is attributed to increase in thyroid and blood pressure medication more so than the Lenvima. Levothyroxine was increased to 75 mcg once daily. Scheduled for repeat labs and Keytruda infusion on 10Mar2021. Stated will discuss with oncologist at that time. Patient stated systolic blood pressure remains in 130s, but diastolic blood pressure remains in 90s. Continues to monitor and record and will discuss with oncologist on 10Mar2021. Most recent labs indicated CA125 levels decreased from 340 to 73. Stated oncologist is pleased with her progress. Scheduled for repeat scan at end of March. The patient underwent lab tests and procedures which included blood pressure diastolic: 90s on an unknown date, blood pressure systolic: 130s on an unknow date, CA125 levels: decreased from 340 to 73 on an unknown date.  The action taken in response to the event for lenvatinib mesilate and levothyroxine sodium was unknown. Outcome of the event dizziness was recovered, outcome of the event increased shortness of breath was unknown.  Pfizer is a marketing authorization holder of levothyroxine sodium in the country of incidence. This may be a duplicate report if another marketing authorization holder of levothyroxine sodium has submitted the same report to the regulatory authorities.
Diarrhea for the past month after receiving 2nd vaccine on May 4, 2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0175) via an unspecified route of administration on 04May2021 (at the age of 52-year-old) as a single dose for COVID-19 immunization. The patient had no medical history and known allergies. Concomitant medications were not reported. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0161) via an unspecified route of administration in left arm on 13Apr2021 as a single dose for COVID-19 immunization and experienced mensural cycles again after 5 months into menopause. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021, the patient experienced diarrhea for the past month after receiving the second vaccine. The patient did not receive any treatment for the event. The outcome of event was not recovered.  Follow up attempts needed. Further information is expected.
could hardly move; all she wants to do is sleep / more sleepy than she already is experiencing; ached from head to toe; arm was red; arm itching; This spontaneous case was reported by a nurse and describes the occurrence of HYPOKINESIA (could hardly move), SOMNOLENCE (all she wants to do is sleep / more sleepy than she already is experiencing), PAIN (ached from head to toe), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE PRURITUS (arm itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Diabetes.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced HYPOKINESIA (could hardly move), SOMNOLENCE (all she wants to do is sleep / more sleepy than she already is experiencing), PAIN (ached from head to toe), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE PRURITUS (arm itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) for Itching, at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (could hardly move), SOMNOLENCE (all she wants to do is sleep / more sleepy than she already is experiencing), PAIN (ached from head to toe), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE PRURITUS (arm itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   List of concomitant medication were not given. She received the Moderna Booster shot on 29oct2021 (more than 6 months after her first 2 shots).
Pt called at 12 noon on 07/01/04 c/o hives, rapid heartbeat and dizziness which she believes are the result of her Hep shot given 6/30/04. Instructed client to call her family Physician. 7/2/04 client has not returned call from me.
My heartrate was beating really fast. I went to the hospital that following day. The Doctor performed a EKG and I was told that it just means the vaccine is working.
Golf ball sized, painful lymph node in bend of left arm.  Right at elbow; Golf ball sized, painful lymph node in bend of left arm.  Right at elbow; Mild diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 13:00 (Vaccination at the age of 53 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity (Known allergies: Sulfa) from an unknown date. There were no concomitant medications. The patient previously took acetaminophen and experienced drug hypersensitivity, bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: ER7833), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 14:30 (Vaccination at the age of 53 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced golf ball sized, painful lymph node in bend of left arm. Right at elbow and mild diarrhea on 14Apr2021 08:30. Patient didn't took other vaccine in four weeks, didn't had covid prior vaccination and not tested covid post vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
All patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days BUD; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days BUD) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (All patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days BUD) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   there were 100 vials (1000 doses) received and kept at appropriate refrigeration temp 2C-8C since the morning of 6/15/21. Unfortunately, at 30 days after the storage in appropriate refrigeration temp, the vials continued to be used in the clinic and administered to patients. There were no temperature excursions from 6/15/21 through 7/28/21, but all patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days. The vials were removed from refrigeration after each day of use, and were administered or wasted within 8 hours at room temp (21C-22C).  No concomitant medications were reported.  No treatment information was provided.
Within about 60hrs of DTaP, MMR vaccine patient developed a simple febrile sz. ? secondary to vaccine or viral illness.
Right after the shot. I got light headed and dizzy. My arm was sore. I was fatigue. My arm had swell and I had broken out in hives and rash. I had migraine. Flu symptoms
Chills; Fever/ slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever/ slight fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 05-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 05-May-2022, the patient experienced CHILLS (Chills) and PYREXIA (Fever/ slight fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever/ slight fever) was resolving.            No concomitant medications were reported.  Patient stated that she received her Covid booster dose on 05-May-2022 and had chills and a slight fever. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recv vax 24JUN97 & 6JUL97 pt exp nausea & macular papular rash on most of body & presented to a healthcare professional;
I did get the 2 shots and I'm still on meds for nerve pain.; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received Shingrix and had nerve pain. No contact details were reported. For tolerance of 2nd dose, refer case US2021AMR151897, reported by same reporter. Note : Since the reporter did not specify temporality between the event and the doses of vaccine( if the nerve pain was experienced after the first or second dose), Hence case was processed conservatively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151897:Same reporter
Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history and no known allergies who on 12-NOV-2009 was vaccinated with a 0.5ml IM dose of GARDASIL (Lot# 663453/0249Y) and a meningitis vaccine (manufacturer unspecified) while pregnant (third trimester). There was no concomitant medication. On 12-NOV-2009 an ultrasound test was performed which showed the patient was 31 weeks of gestation. Her due date was 13-DEC-2009. Subsequently the patient experienced preeclampsia and was admitted in the hospital. Labor was induced and the child was healthy. At the time of the report the patient had recovered. The reporting physician considered preeclampsia to be immediately life-threatening. A lot check has been initiated. Additional information has been requested.
partial dose administered; Dripped down the patient's arm; Dripped down the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date 12th May 2023) for prophylaxis.   On 23rd May 2022, the patient received the 2nd dose of Shingrix. On 23rd May 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.       Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments:  The pharmacist stated a Shingrix syringe malfunctioned and most of the vaccine dripped down the patient's arm. It was unknown what was volume administered successfully. This was supposed to be the patient's second dose. The reporter was consented to follow up. No further details provided during call, pharmacist grants permission for safety and quality to follow up. Additional Supportive Information: A Shingrix syringe malfunctioned and most of the vaccine dripped down the patient's arm, which led to incomplete dose administered, exposure via skin contact, Inadvertent exposure to vaccine.