chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 66 year old man was treated with OncoTICE. After the first or second instillation he experienced worsening of his rheumatoid arthritis (back pain, joint pain, leg pain) and chills. Due to the events OncoTICE was discontinued. Medication resolved the events only temporarily. His treating urologist told him that the events were not related to OncoTICE. Medrol dosepak, Advil.
she experienced hives on her lower back; allergic to an ingredient in the Shingles vaccine; have COPD; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUL-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: she experienced hives on her lower back), allergic reaction (Verbatim: allergic to an ingredient in the Shingles vaccine) and chronic obstructive pulmonary disease (Verbatim: have COPD).  The patient was treated with benadryl (nos) (Benadryl). The outcome of the hives was resolved and the outcome of the allergic reaction and chronic obstructive pulmonary disease were not reported.   It was unknown if the reporter considered the hives, allergic reaction and chronic obstructive pulmonary disease to be related to Shingrix.     It was unknown if the company considered the hives, allergic reaction and chronic obstructive pulmonary disease to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2023 and 18-SEP-2023 The patient self-reported this case. After receiving her first dose, the patient experienced hives on her lower back. Hives resolved after taking Benadryl. The patient stated that she was allergic to an ingredient in the Shingles vaccine that was given to her in 2021 and at pharmacy when she tried to get the RSW Pfizer vaccine Abrysvo the computer told the pharmacist she might had an allergic reaction as the component of the Shingles vaccine was in the RSV vaccine. They did not know the ingredient that was in the question. Pharmacy stated they did not know that there were 2 types of vaccines for RSV so the patient was wondering if the Arexvy vaccine might not had that component. The patient had COPD and the patient really need to take one of these vaccines. The patient asked for the ingredient of the Arexvy vaccine. The reporter consented to follow up.
This spontaneous report as received from 2 registered nurses refers to an 11 year old female patient. The patient had a history of drug reactions described as hives to amoxicillin and penicillin on unspecified dates. On 27-NOV-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J006236, expiration date 25-FEB-2016, dose not reported), intramuscularly in her right deltoid. There was no concomitant therapy. On an unspecified date, the patient's vaccinated arm was sore for an unspecified period of time after vaccination with the first dose of GARDASIL. On an unspecified date, the patient recovered from the adverse event after an unspecified period of time. On 18-JAN-2014, the patient was vaccinated with the second dose of GARDASIL (lot # J010668, expiration date 29-APR-2016, dose not reported), intramuscularly in her left deltoid. On an unspecified date in 2014, the patient's vaccinated arm was sore for an unspecified period of time after vaccination with the second dose of GARDASIL. On an unspecified date in 2014, the patient recovered from the adverse event unspecified period of time. On 03-JUN-2014, the patient was vaccinated with the third dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016, dose not reported), subcutaneously in her right arm. The patient did not seek medical attention. Treatment was not given. No lab performed. It was unspecified if the patient's arm continued to be sore after the dose administered subcutaneously on 03-JUN-2014. Additional information has been requested.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and frequency unspecified). Concomitant medications were not reported. On an unknown date the patient experienced developed rash after receiving ZOSTAVAX. No product quality complaint was involved. The outcome of rash was unknown. Causality assessment was not provided. Additional information has been requested.
Pulmonary Embolism.  Symptoms - severe pain in right side, shortness of breath, lasted for 24 hours until admitted to Emergency Room
I've had diarrhea, vomiting, abdominal pain and rectal bleeding.
About 10 minutes after receiving vaccine, patient experienced severe lower back pain that she described as kidney pain. She rested for about 10 more minutes and the pain went away. After getting adjusted at home, the pain started again, along with nausea/vomiting, chills/fever. Patient says this lasted about 3 days. She came back into the pharmacy to report those symptoms on 10/22/19.
Pt call pharmacy at approximately 850 pm stating his "face is swelling"-instructed pt to go to emergency room for possible anaphylaxis.
Approximately 2 weeks after vaccination, patient diagnosed with UTI. Was prescribed a course of Cephalexin. Patient did not take full course but symptoms resolved one day after initiation. Approximately one week later, he began to experience a metallic taste for about 1.5 days, followed by right sided facial palsy. As of date of this report, facial palsy has not resolved.
COVID after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID after vaccination) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID after vaccination). At the time of the report, COVID-19 (COVID after vaccination) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.  The patient received the first 2 doses of the Moderna vaccine and then developed COVID disease. The patient was being cautious too because the patient has a diabetic son.  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The patient received the first 2 doses of mRNA-1273 vaccine then developed COVID disease. The dates of vaccination and onset of the event were unknown. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-527476 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The patient received the first 2 doses of mRNA-1273 vaccine then developed COVID disease. The dates of vaccination and onset of the event were unknown. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
SOB resulting in near respiratory arrest, pt intubated.; SOB resulting in near respiratory arrest, pt intubated.; This is a spontaneous report from a contactable other hcp. A 66-years-old female patient received BNT162B2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 30Apr2021 11:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunization. Medical history included drug hypersensitivity to sulfa from an unknown date. It is unknown that the patient received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. On 30Apr2021 the patient experienced sob resulting in near respiratory arrest, pt intubated. The event resulted in Emergency room/department or urgent care. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of SOB results in near respiratory arrest cannot be excluded but also consider relevant medical history and concomittant drugs and drug history. 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  Committees and Investigators, as appropriate.
Patient is a 70 Y male Covid positive complaining of shortness of breath DDx includes, but is not limited to COVID-19 disease, COPD and pneumonia Patient was seen and examined.  Blood was obtained and sent to lab.  Chest x-ray was obtained and results reviewed. Patient was ambulated by the bedside.  His oxygen saturation decreased to 87%. 11/17/21 - admitted, started on remdesivir and decadron    11/18/21 - symptoms improved, treatment course continued    11/19/21 - symptoms remained absent (with respect to COVID), patient reporting his breathing and energy feel at their normal baseline and wishes to go home, discussed with him and his daughter comfort level for going home - both are comfortable, oxygen saturations at baseline (99% on 2 liters), d/ced home after PT eval and 3rd dose remdesivir
PT complained of lightheadedness, nausea and pain 15 minutes after vaccination.  At assessment BP 125/80 HR 72 O2Sat 98  Breathing unlabored.  PT denies trouble breathing.  PT stated she has a chronic condition (Ehlers Danlos Syndrome) and POT. PT stated she has episodes with same symptoms and these episodes could last hours.  PT also stated pain was part of the S/S of the syndrome.  BP stayed same, O2 sat and HR WNL at 2:30pm  PT was accompanied by her husband and she was discharged from our care with indications to seek medical help if symptoms do not improve or worsen.
heart murmur has gotten worse (echogram done and it got worse); heart murmur has gotten worse (echogram done and it got worse); I could feel it in my stomach right away but that went away; chills; anxiety attack; One day I slept all day; One day of the prickly feeling but that went away; High blood pressure; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 97-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient could feel it in her stomach right away but that went away. She had chills, anxiety attack during the night. One day, she slept all day. One day of the prickly feeling but that went away. High blood pressure, heart murmur has gotten worse (echogram done and it got worse). How strong was the 2nd shot, is it the same or different and what was the efficacy of one dose. She wanted to know should she get the 2nd one. The seriousness of the events was reported as non-serious. The patient underwent lab tests and procedures which included echogram: heart murmur has gotten worse on an unknown date. The outcome of high blood pressure, one day I slept all day, anxiety attack, chills was unknown; heart murmur has gotten worse (echogram done and it got worse) was not resolved and I could feel it in my stomach right away but that went away, one day of the prickly feeling but that went away was resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
There was not an actual adverse event. Patient received Pfiezer vaccine instead of receiving Moderna vaccine. No adverse reactions took place.
12/03/21 (10:10 AM)  Pt received 0.20ml (correct dose) of PEDIATRIC PFIZER lot #FK5618 (wrong medication) IM in Left Deltoid (correct site). Medication error was recognized immediately after administration. Error was reported to company management, CDC was contacted by phone, pt was informed.  CDC instructed a full dose of ADULT PFIZER to be administered to pt. 11:10 AM  Pt received 0.30ml adult Pfizer lot #30155BA IM in Left Deltoid 1 inch (lower and to the right) of the initial vaccine. (Pt requested Left Arm) Pt was monitored for additional 20 min. Pt reported "feeling great", "no harm, no foul", and "great customer service".  12/03/21 3:23 PM called pt for follow up. Pt reported "Feel great. Going to go work out".  12/06/21 11:08 AM called pt for follow up. Pt reported "Feel great", "never felt better", "literally zero symptoms, was kickboxing all weekend".
Fatigue; This spontaneous case was received on 17-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01895) and concerned an 80-year-old, male patient.   The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with Influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location: not reported] for influenza prophylaxis. The batch number was not reported. The reporter stated she did not know for sure which vaccine was received, but she thinks it was the one for seniors.  On an unspecified date, unknown amount of time after receiving Influenza virus vaccine polyvalent, the patient experienced fatigue.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Case updated on 25-Sep-2020: Correction made to information received on 17-Sep-2020: Company comment added.   Case updated on 27-Nov-2020: Correction made to information received on 17-Sep-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. No change in the narrative.  Company comment: The event of fatigue is assessed as related to Influenza virus vaccine polyvalent.; Sender's Comments: The event of fatigue is assessed as related to Influenza virus vaccine polyvalent.
Lt arm swollen and red at injection site. Seen by MD - to Tx with ADVIL and ice.
swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental implantation on 20-Jan-2021.   On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced SWELLING (swelling). At the time of the report, SWELLING (swelling) had not resolved.            The patient's concomitants had not provided. Treatment was not provided.  Patient want's to confirm if she can take prednisolone for dental implantation.  Action taken with mRNA-123 is not applicable.; Reporter's Comments: patient wants to know if she can take prednisone prescribed to her after receiving two dental implants at the dentist on 20jan2021 to help treat the swelling. She reports having the second Moderna COVID-19 vaccine on 19Jan2021.
Ruptured appendix on 4/23/21  Surgery performed.  In hospital for 7 days.  After I went home developed an infection C-Diff and was treated with Vancomycin 500mg for 6 weeks after cultures were done by my gastroenterologists.
After 10 minutes from vaccine patient came to counter said felt itching around ear and neck and slight pain. Wanted to get benadryl from her car.  We gave patient 50mg of Benadryl which she stated she has taken before as a premed before vaccines (FLU) and procedures.  Had patietn sit and gave water and checked on her every 5 minutes.  After 1 hour (1 hour 15 minutes) from vaccination patient stated wanted to leave felt better no more issues or symptoms.  Both her Endocrinologist and Kidney Transplant doctor were notified per patient and if they want her to get second dose will do so at their facility.  Advised patient if symptoms return call 911 or go to ER. Will follow up with patient tonight.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 13-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Breakthrough covid infection despite the fact that I was fully vaccinated; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated). At the time of the report, COVID-19 (Breakthrough covid infection despite the fact that I was fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Additional information received included reporter information, patient details, route of administration, vaccine indication, and  lab data.; Sender's Comments: This case concerns a 54-year-old male patient with no relevant medical history reported,  who experienced non serious unexpected event of special interest  CVODI-19. The event occurred approximately a month after the second dose of Spikevax. Rechallenge was not applicable since the event occurred after the second dose.  The benefit-risk relationship of drug is not affected by this report. Lack of efficacy not reported since there are no exact dates of vaccine administration provided.
Pregnant patient took Typhim VI/ No AE; Initial and additional information received on 15-Dec-2021 regarding an unsolicited valid non-serious case from a other health care professional via physician.  This case involves a 39 years old female pregnant patient who was exposed to TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported.  The date of Last menstrual period was within weeks, the patient states she had just found this out.  The estimated due date was not reported.  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  The patient previous pregnancy was not reported.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), YELLOW FEVER VACCINE LIVE (17D-204) (YF-VAX) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) for prophylactic vaccinations.  On 02-Dec-2021, the patient received a 0.5 ml total dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (frequency: once, strength: standard, lot number: UQA431M and expiry date: 03-Oct-2023) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency: same day).  It was reported "Nurse is looking for information on if there is a registry for pregnant patients that have been administered a dose of YF-VAX, as they state they have had to do that for other vaccines. Caller mentions giving patient Typhim VI during visit."  Product used: Used and Still using product: No.
Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine; Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine; Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine; Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Aug2021 12:00 (Lot number: ewo183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: NEXUS [AMLODIPINE]; VITAMIN D COMPLEX; IRON. The following information was reported: DYSMENORRHOEA (non-serious), MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), INTERMENSTRUAL BLEEDING (non-serious) all with onset 24Aug2021, outcome "unknown" and all described as "Early period, extended period, spotting, unusual intense cramping. Happened to myself and daughter at the same time after vaccine". Therapeutic measures were not taken as a result of dysmenorrhoea, menstruation irregular, heavy menstrual bleeding, intermenstrual bleeding.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient dose not received treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101112243 Same Vaccine/event, different  patient
She got her vaccine and has had weak muscles, very stiff joints in her shoulders and hips.  She thinks she could have problems with bladder control.  Mainly it's the problem with the joints.  Right now it takes her (timed it from time to lean down and get something off the floor) takes about 8 seconds to get down and stand back up.  Very sluggish and can only sleep 2-3 hours a night as when she wakes up she tries to move to another position and cannot do so so she gets up.  She takes quite a few naps during the day.  She wants to cry.  She woke up this morning about 3:00 AM and she cries because she cannot get comfortable, and can't move her shoulders, and commiserating that she is in a great deal of pain and does not know how long she can take this.  She took steroids for a little bit and was doing better, and now is back to slow moving behavior and it is not fun.  She is not sure whether she wants to live like this or not.  She did go to her doctor and told her that she is having an adverse affect from the COVID shots, and is back to square 1 when she can barely get out of bed, and can barely do anything and is a mess.