chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all muscles hurt; itchy over upper arm and very large area 3 to 6 inches; pain at the injection site; redness; little pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy over upper arm and very large area 3 to 6 inches), VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), MYALGIA (all muscles hurt) and PAIN (little pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025T20A or 025G20A not sure and 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (patient medical history was not reported). Concomitant products included CARVEDILOL for Heart attack, PREGABALIN (LYRICA) for Pain.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (little pain). On 12-Feb-2021, the patient experienced PRURITUS (itchy over upper arm and very large area 3 to 6 inches), VACCINATION SITE PAIN (pain at the injection site) and ERYTHEMA (redness). On 16-Feb-2021, the patient experienced MYALGIA (all muscles hurt). At the time of the report, PRURITUS (itchy over upper arm and very large area 3 to 6 inches), VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), MYALGIA (all muscles hurt) and PAIN (little pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Muscles and joint gradually became stiff, sore, and painful over the course of the evening and night after vaccination. By approximately 12 hours after the vaccination, it was difficult to move or sleep because of extreme joint and muscle stiffness. Aspirin had only a minor effect on the stiffness and pain. There was no fever. By about 18 hours after the vaccination, the symptoms began improving, which allowed for some movement and sleep, but I was unable to go to work in the morning (after the vaccination on the previous afternoon). By approximately 24 hours after vaccination, the symptoms started to improve rapidly, finally enabling me to go to work at about 24 hours after vaccination.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified doses of GARDASIL (lot # J009788, expiration date 17-MAR-2016; dose and route not reported) which were improperly stored from 05-SEP-2014 through 01-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I still have headaches daily; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 16:45 (Lot number: 3101) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Apnea" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, single, Batch/Lot No: 3101 , Location of injection: Arm Left , Vaccine Administration Time: 16:45), administration date: 04Aug2021, when the patient was 42 years old, for Covid-19 Immunisation, reaction(s): "had only partial vision in my left eye", "my eyes begin to water 2 days later", "I started to have racing heart palpitations even while lying in bed", "major headaches", "Non arthritic ischemic optic neuropathy OS". The following information was reported: HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "I still have headaches daily". The event "i still have headaches daily" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No.List of any other medications the patient received within 2 weeks of vaccination:No.After receiving the first dose of vaccine my eyes begin to water 2 days later I started to have racing heart palpitations even while lying in bed and major headaches. On the 10th day I woke up and had only partial vision in my left eye. I then went to see a eye specialist. I had numerous tests and an mri. The heart palpitations went away after 2 weeks my vision returned after 1 month. I still have headaches daily.What treatment received for the adverse event: Eye drops pataday.Prior to vaccination, was the patient diagnosed with COVID-19:No.Since the vaccination, has the patient been tested for COVID-19:No.Did the patient provide information to you regarding the reported adverse event(s) with the use of the product: Yes.If yes above, do you consider the Pfizer product had a causal effect to the adverse event:Yes.Concomitant Drugs: Unknown.Relevant Test: Unknown.Specific relevant test for thromboembolic events with thrombocytopenia: Unknown.Seriousness Criteria: Not serious.Treatment: Did the event require the initiation of new medication/other treatment/Procedure: No.Pt presented 31Aug2021 complaining of headaches, tearing and loss of vision in 10 days after having first COVID vaccine we found dense superior VF defect OS on VF testing. we referred patient to retinal specialist who diagnosed Pt. with Non arthritic ischemic optic neuropathy OS. To my knowledge this pt had no risk factors systematically that would predispose her to this.  No follow-up attempts are possible. No further information is expected.
Brain fog, usually when you kind of feel retarded like you had a concussion or stroke or high altitude sickness; Brain fog, usually when you kind of feel retarded like you had a concussion or stroke or high altitude sickness; Brain fog, usually when you kind of feel retarded like you had a concussion or stroke or high altitude sickness; like less oxygen in the brain you just feel kind of gazed or confused or you feel extremely tired; then you have to lay in bed and deal with vertigo until you; feel extremely tired/ We all had tirednes; This is a spontaneous report from a contactable nurse (psychiatric nurse at a mental institute; reporting for the family member who also got the Pfizer also had the same symptoms (as reported)). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for covid-19 immunization. Patient mentioned that it was from like 2 or 3 months ago when patient got the full vaccine (2021), age was 33 (not appropriately clarified). The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2021, patient had brain fog, usually when your kind of feel retarded like you had a concussion or stroke or high altitude sickness like less oxygen in the brain you just feel kind of gazed or confused or you feel extremely tired. Patient had tiredness, went to sleep for 8 hours, wake up for 2 or 3 hours, and get some coffee, then was really tired, then have to lay in bed and deal with vertigo until "you (incomplete sentence)". The outcome of the events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up,; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. This case will be reassessed when additional information becomes available. 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.
tested positive for Corona; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Corona) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunodeficiency (weak immune system).    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (tested positive for Corona). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-Jul-2022 to 19-Jul-2022 at a dose of 100 milligram. At the time of the report, COVID-19 (tested positive for Corona) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) tested positive for Corona.         No concomitant medications were reported.  The patient confirmed that all of the COVID-19 vaccine shots that he received was with Moderna and was also about to get his second booster dose as Moderna COVID-19 vaccine but he was advised by his doctor to wait 60 days after taking Paxlovid before getting the COVID-19 vaccine. Patient also stated that his immune system was weak and it would be easy for him to get COVID. His last COVID-19 vaccine shot was 8 and a half months ago.  Company comment- This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-CoV test), which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient was given paxlovid for 5 days. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-CoV test), which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient was given paxlovid for 5 days. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient states a rash appeared on his chest three days after immunization was administered, no rash at injection site, on his chest only.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received the 2nd dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: the age at vaccination of the patients was not reported. the sales representative reported that multiple patients in the healthcare professional's office reported pain in their arm after receiving 2nd dose of BEXSERO vaccine. No further information was provided.
Information has been received from a physician concerning a 20 year old female patient who on unspecified dates was vaccinated IM with all three doses of GARDASIL (Lot # not provided). The physician stated that the patient received all three doses of GARDASIL and "recently" came in for an annual exam and the tests came back ASCUS (atypical cells of undetermined significance). The patient sought unspecified medical attention. At the time of this report the patient's outcome was reported as not recovered. Follow up information has been received from the physician who stated that there was not an adverse reaction. The physician reported that the patient had an abnormal Pap following therapy with GARDASIL which is expected due to the many HPV virus subtypes. Additional information is not expected.
sore arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gout. Concomitant products included ALLOPURINOL for Gout.    On 24-Mar-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 VACCINATION SITE PAIN (sore arm injection site). At the time of the report, VACCINATION SITE PAIN (sore arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided
has received a few prescriptions to repeat Shingrix series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in an unspecified number of patients who did not received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patients had already completed the Shingrix series).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug prescribing error (Verbatim: has received a few prescriptions to repeat Shingrix series). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023. The pharmacist stated that her pharmacy had received a few prescriptions to repeat Shingrix series in patients that had already completed the series.   The pharmacist reported that she believed the patients are usually around 3 years out from completion of the series.   The pharmacist did not had any patient information at the time of reporting.   She did not known the number of patients, she stated that they receive a couple here and there, it's an occasional thing.   No repeat doses had been administered. The reporter consented to follow up.
pt recv vax & devel 12 lesions w/generalized rash;pt sought unspecified medical attention;
(R) arm pain and swelling 5 days after administration of GARDASIL vaccine. Possible late reaction to vaccine.
8/21- felt light headed, brain fog, headache starting around 8:00 pm; 8/22- woke up with 100.7 degree fever, severe headache, fatigue, malaise, brain fog, dizziness, swelling in lymph node under left arm, highest measured fever 102.4 around 4:00 pm, 101.8 fever around 8:00 pm; 8/23- temp down between 100.5 around 7:00 am to 99.0 around 8:00 pm, all other symptoms from 8/22 present; 8/24- woke up around 2:00 am with swelling, warmth, and rash at injection site that is tender to the touch and tender when left elbow or shoulder are moved, continued swelling of lymph node, mild headache, fatigue, temp down to 98.1 around 5:00 am
Pt call 9AM rash developed/itching on both arms from arm pit to elbow, interior arm started 7:30 A advised patient to notify MD and take antihistamine unless MD consults otherwise. No other changes made.
Patient received booster dose which had exceeded the recommended 12 hour open vial recommendation but was at appropriate temperature. There was no signs of adverse event as a result of this.
Became unresponsive during non emergency transport to dialysis.  Rerouted to nearest hospital. Transport company failed to supply hospital with patient info. Was admitted as generic patient around 5pm on Sept 3, 2021. Transport company failed to contact me with patient unresponsive, and emergency location. I couldn't locate my son until after midnight.
Lower Facial swelling under the nose. Given Benadryl and Antihistamine every 6 hours for several days. Four days later swelling went down.
Sore arm, shoulder and shoulder blades around 6:00pm.  Headache, chills temp 100.2 all evening.  Next day headache and sore arm, shoulder and shoulder blades and neck.  Slight chills.  By day three just sore arm and shoulder.  Other symptoms gone.
Mom reported patients right thigh was red and swollen.  Patient was assessed.  Area was tender to touch.  Red area was marked and parent told if red area goes beyond  the marked area to return to clinic.  Patient did not have a fever.     Provider asked to have the Prevnar vaccine taken out of circulation and called manufacturer who has opened an investigation to the prevnar lot. (Contacted Pfizer regarding reporting 2 adverse reactions to Prevnar 13  lot #DL2971 Reference #: IUNKJM6S)  Our office has been in contact with parent to see how patient is doing.  As of this morning redness and swelling are going away.  Mom does state patient does have a knot in the area.  Also our office is keeping parent up to date on the steps taken regarding the adverse reaction.
3 patients administered expired doses from 27July2021; 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 (3 patients administered expired doses from 27July2021) 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 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients administered expired doses from 27July2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients administered expired doses from 27July2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: follow up information received on 31-AUG-2021 contains No new information
HAD NO PROBLEMS UNTIL 1 WEEK LATER. ON 1-6-21, PATIENT DEVELOPED LUMP AT INJECTION SITE. REDNESS, WARM TO TOUCH, SORENESS AND ITCHING. ON 1-7-21, LUMP HAS DISAPPEARED, LESS SORENESS BUT REDNESS AND ITCHING REMAIN.
Patient came back 2 weeks later saying her arm flared up with redness, shooting nerve pain for the whole arm and it was swollen. The symptoms lasted for a week and she mentioned to her doctor at a doctor's visit but the doctor had no comment and didn't prescribe any medications for the symptoms because they were almost all resolved per patient. Patient said she didn't apply ice pack or take any pain meds when she experienced the symptoms. She didn't do anything. Patient declined to provide doctor's name and contact info because doctor didn't give any comment nor treat her for it. Patient indicated she's fine at the time when she first notified us 2 weeks after the vaccine.
slightly sore arm; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case is linked to case 2020SA292550 (same reporter).  This case involves patient (unknown demographics) who experienced slightly sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious slightly sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Patient is reporting that That is definitely a myth. Nothing in INFLUENZA VACCINE to give the flu.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.  There will be no information available on the batch number for this case.
Hemophilus influenza Meningitis/sepsis 10 days after immunization.
Child developed a hive on her forehead and generalized itchiness 10 minutes after vaccine was given, child given Benadryl at that time and within 10 minutes of medication child was improved. Child left clinic with mom under own power.
About 24 hrs after the vaccination, I had fever reaching 104 deg for about 36 hrs. Several days later I began having afternoon/evening fever every few days. These fever events became more frequent until they were occurring almost every day as the frequency increased so did the fever exceeding 104 deg on occasion. I have had many tests at two hospitals, seeing numerous doctors who have classified me as a FUO (fever of undetermined orgin). Due to the lapse of time since the August 23, 2001 vaccination, the doctors have virtually ruled out infection as a cause of my fever. In view of this, there is a distinct possibility that the vaccination triggered an event that may be causing my feve.
Some pain in arm as expected, mild fever (around 99.8), very sore throat, dizziness, no appetite at all, exhaustion, slept most of the time for like 3 days. Initially I thought it was the flu although I had the flu shot. See item 20: feeling better, but not yet 100%.
I do not know which of the flu vaccines I had. I had ZERO idea there were choices. I thought you got the "FLU VACCINE" necessary for that year. I got Guillain Barre, however I did not know that is what I had. Severe Neuropathy in fingers, could not touch anything.. lasted 24 hour at severe and another 24 hours at mild to moderate... was gone by third day. My skin doctor let is the one who said  Guillain Barre. I also called the pharmacy and they said don't come back we won't give you anymore shots.
The Inmate described his reaction as "bad shakes, non stop" for 9 days, loss of taste for 4 to 5 days.  He did not or could not seek care at that time.  He reported these symptoms when asked about receiving the vaccine.
Pt received PNEUMOVAX on 10-13-11. On 10-15-11 reports soreness & slight rash on 2 areas in administration arm. Pt states taking TYLENOL PRN & was advised to also use BENADRYL topically.
sharp pain immediately after vaccine, pain has persisted for now the two weeks post and continues. sharp pain, sore muscular pain, hurst to lift arm, tender
Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown".  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.