chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and DRUG INEFFECTIVE (Drug ineffective) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 10-Aug-2022, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (Covid-19) was resolving and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. No treatment medication were provided. It was reported that patient had COVID-19 test in Aug-2022.  Company comment: This spontaneous case concerns a 42-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 11 months and 3 weeks after receiving the third dose of mRNA-1273 vaccine.  Additionally, Drug ineffective was also reported.  The interval between the first and second doses of mRNA was noted to be 31 days. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 11 months and 3 weeks after receiving the third dose of mRNA-1273 vaccine.  Additionally, Drug ineffective was also reported.  The interval between the first and second doses of mRNA was noted to be 31 days. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-MAY-2016, the patient was vaccinated with a properly stored by expired dose of RECOMBIVAX HB (which had lot # reported as L006233 and expiration date 03-APR-2016; however dose, dosage number and route of administration were not reported). No adverse events reported. No product quality complain (PQC) was involved. Additional information has been requested.
patient was given expired VAQTA; This spontaneous report as received from a medical assistant and refers to a 39-year-old male patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 28-DEC-2020, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, intramuscular injection (anatomical location and strength were not provided) lot # S025258, expiration date 05-NOV-2020, for prophylaxis. At the reporting time the patient seems to be fine and have not sought for medical attention. No product quality complain was present. The patient did not die and the event of administration of expired vaccine was not life threatening. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Pt had called saying that the day after shot was administered her ear had swelled up. Then the day after that her left cheek swelled up and her ear had reduced swelling. Then after taking Ibuprofen and placing cold packs/ice the swelling from both ear and cheek resolved.
Pain at injection site and numbness in hand and arm immediately after injection. Uncontrollable shaking 6 hours after injection that lasted for one hour. Fever, muscle pain, headache, chills, and nausea 7 hours after injection.
I had an extreme amount of sneezing and runny nose for a few days. I had a cough and dizziness. The worst was the fatigue where I couldn't stand up to take my inhaler. After that I got a secondary sinus infection and was left with long COVID-19 which I still have. I am left with some symptoms up until now like fatigue, low energy primarily. For a while I had heart palpitations and shortness of breath but these have gone now.
Pt complained of sparklings in her eyes then later complained of little tightness in her throat and feeling fire at the injection site.
prolonged sz lasting 2 1/2hr;fever 38.8;pulse 166;resp rate-38;treated w/Ativan, dilantin/phenobarbital;head CT scan, spinal tap, EKG, EEG & all lab tests were nl;
The patient received Td vaccine intradermally in her left forearm by mistake on 12/10/07; she was supposed to have received PPD.  Two days later, on 12/12/07, the patient returned to the doctor's office to have her PPD test read; it was at this time that it was discovered that Td had been injected instead of the PPD. The patient had a local site reaction approximately the size of a silver dollar consisting of swelling, redness, hardness, and pain.  She has to systemic adverse reactions, and the patient was walking, talking, and acting normal.  The patient will be returning to the doctor's office to receive the PPD correctly in one week.  The local reaction will also be monitored at this time.  Follow up information received 01/02/2008: A representative from the practice stated that the patient had recovered from the local site reaction.
Around 12/26/2022, I noticed, while asleep, I was experiencing shooting pain in my feet and toes. It would wake me up and I needed to take ibuprofen. I was almost nervous to go to sleep in fear of waking up with the pain. I also started to experience intense body aches, things tasted different, felt congested, slight fever and I always felt like I was smelling burnt toast. I tested myself at home, on an expired test, and it came back positive. I had a feeling the test was correct, but I went to the pharmacy to get tested and that test came back positive as well. I did not contact my doctor because when I looked on the website, it showed that they were not doing anything with patients that tested positive. I asked my husband's doctor if there was anything I should do, and he told me to just stay home, take ibuprofen/TYLENOL and rest. I am still experiencing head congestion as of today.
Dad called in PM, day of immunization stated child vomited x 4 since receiving vaccine. Advice given re: possible virus illness. Call if change or no improvement.
Post Vaccination, patient started feeling dizzy. Alert and oriented x4, able to provide health information, denied  SOB or respiratory discomfort. Patient's BP 96/62, Pulse 60, o2 sat 99%, RR 19. Patient  came with her sister who will be the designated driver. Patient requested to stay outside for the rest of observation period. Patient repeatedly said the dizziness is not related to the vaccine, patient also mentioned she has chronic dizziness and its not something new.  Patient education provided and encouraged to call her PCP ASAP. Patient was discharged with her sister in law, patient said she felt better, no complaints.
Crying; Agitated; Body aches; Headaches; Patient received third dose in error on 13th January 2020; Severe fever at 105 Fahrenheit; This case was reported by a consumer via call center representative and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (1st dose received on 13th June 2019, refer linked case US2020233733) and Bexsero (2nd dose received on 21st August 2019).   On 13th January 2020, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 13th January 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after starting Motrin, the patient experienced extra dose administered. On an unknown date, the patient experienced fever, crying, agitation, general body pain and headache. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the crying, agitation, general body pain, headache and extra dose administered were unknown.   It was unknown if the reporter considered the fever, crying, agitation, general body pain and headache to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had received a third dose of Bexsero in error and she had severe fever at 105 Fahrenheit, and she was crying, agitated, had body aches, and headaches.  She was taken to the Emergency Department and all test came back negative and was told that the fever was due to vaccine injury.  The patient was then taken home and was given Motrin alternating with Tylenol and it took 5 days for the fever to resolve.  The reporter did not consent to follow-up and neither wanted to provide her address or phone number nor wanted to provide health care professional information. This case has been linked to US2020233733 (same patient), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020233733:same reporter
In September I started having pain in my hip joint.  In October it spread to my shoulders.  Severe pain throughout my joints
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 18-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 01-MAR-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
discomfort  under her arm pit in both arms; Her breasts feels tender and swollen; Her breasts feels tender and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Apr2021 09:50 (Lot number: ER8736) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 02May2021, outcome "not recovered", described as "discomfort  under her arm pit in both arms"; BREAST TENDERNESS (non-serious), BREAST SWELLING (non-serious) all with onset 02May2021, outcome "not recovered" and all described as "Her breasts feels tender and swollen".  Additional information: On 02May2021 caller began to experienced discomfort under her arm pit in both arms to days later. Pain radiates to her breast, breast are tender and swollen. Caller would like to know if this was a common side effect. Caller would like to know if she would experience the same side effects with second dose. When probed for outcome, she explains its about the same, it's better in the morning and as the day goes on it, it gets a little worse. However, it was not worsening, it was not excruciating or anything, it was just something she does not have before receiving the vaccine. The caller clarifies the discomfort was under both armpits, but more so under her right armpit, radiating to her right breast. Her right breast is more bothersome than her left. She explains she had a little discomfort under her left armpit and left breast, but not much- that kind of was better. She explained she used her right arm more, she was right-handed, which she does not know if that has anything to do with it. No additional vaccines administered on same date of the Pfizer Suspect. Adverse event did not require emergency room or physician office. No prior Vaccinations (within 4 weeks). No adverse event following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Tightness in chest, vascular sensations in head that come and go, muscle sensation that comes and goes in right leg above the knee to the outer side of the knee.  Have not sought treatment as these are indicated side effects.  Will decide to seek treatment if continues or worsens.  Have refrained from exercise. Still can perform daily activities, but seem winded at times.
Family reported she felt dizzy, lost consciousness. Paramedics called, regained consciousness. Blood sugar and BP checked. Taken to hospital.
w/in about 1min of vax pt  c/o funny taste;in about 2min pt was getting hoarse & said throat felt like it was swelling;gave 2 DPH & to ER;
pt states that she got a strange feeling in the left side of her face.  She had a hot streak across her ear and her face.  She had some heat that she felt was moving through the left side of her body.  Her left arm is numb from her elbow to her fingertips.  Her left foot became numb.  Her right foot has also become numb.  She says it feels like her lips and her mouth are numb.  Pt went to bed and when she woke up the numbness was getting worse.  She contacted her PCP that instructed to go to the ER.  She went to Medical Center ER on 4/1 /2021 where they treated her as a stroke patient.   She was given MRI, CT, blood work.  All tests were negative for stroke.  She spent the night and then released to go home to FU w/ Neuro Dr.  Pt saw Dr. and will do more blood work.  She was told these symptoms would probably dissipate.  Pt says she still has some numbness at this time.
About 10 hrs after vaccination started inconsolable crying, nystagmus, T 103. In ED felt to have altered mental status, LP done, normal, blood & urine normal, observed overnight -> back to near-normal.
I went to that night I was woken up at 1am that morning and my chest was pounding. My heart rate was 130 beats per minute resting heart rate. That continued for about a half hour. Went back to bed, at 4:30am it started a again. My heart rate was 128 resting heart rate. For the next several weeks I continued to have rapid heart rate at even giving time. Rapid heart rate lasted 4 in a half months. Found something on the upper right quadrant of my heart. And often heart flutter.
fluzone pfs, that were expired was administered with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health care professional.  This case is linked to cases 2022SA418835(CLUSTER), 2022SA417297(CLUSTER), 2022SA419920(CLUSTER), 2022SA418873(CLUSTER), 2022SA419928(CLUSTER), 2022SA419132(CLUSTER), 2022SA419111(CLUSTER), 2022SA417976(CLUSTER), 2022SA417246(CLUSTER), 2022SA417992(CLUSTER), 2022SA417624(CLUSTER), 2022SA419912(CLUSTER), 2022SA417187(CLUSTER), 2022SA417608(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 1 year old male patient and fluzone pfs, that were expired was administered with no reported adverse event. (Influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (HEPA [Hepatitis A vaccine]) for prophylactic vaccination; pneumococcal CONJ 7V (CRM197) (Prevnar) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for prophylactic vaccination.  On 07-Oct-2022, the patient received suspect influenza quadrival A-B vaccine standard at a dose of 0.5 ml once (lot UT7378MA, expiry date- 30-Jun-2022) via intramuscular route in the left vastus lateralis for immunization.  On 07-Oct-2022 the patient received fluzone pfs, that were expired was administered with no reported adverse event (expired product administered) (latency : same day) following the administration of influenza quadrival A-B vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My husband /got / first dose of Shingrix on 11/27/20 but could not get the 2nd dose; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient was the reporter's hudband. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if the patient should get the 2nd dose only or get the first dose again. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR150813, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150813:same repoter (reporter´s case)
I received the inoculation against the SARS-CoV-2 at around 9:40 a.m., CDT as of FRI., Jun. 11, 2021. Later that night, at approximately 12:00 a.m., CDT, as of SAT., Jun. 12,  2021, I began experiencing what I feel to be adverse side-effects due to the inoculation I received earlier in the day. I began experiencing sharp pain in the brain, due to pressure in a blood-vessel in the brain, as if a blood-vessel in the brain were being clenched due to a blockage, and I also experienced a narcotic-like "high", due to the fact the inoculation, i.e., the  Covid-19 vaccine, includes in its formula of chemical compounds a narcotic which sedates the nervous-system as a narcotic would do, such as alcohol. My view is due to the fact the vaccine never underwent proper FDA-approval, the vaccine will incur serious side-effects in individuals receiving the inoculation form healthcare professionals which did not result in clinical studies in patients receiving the vaccination in clinical trials prior to its introduction to the public, due to the fact the company did not have the time necessary to determine as to whether  or not the vaccine would adversely effect individuals receiving it in certain sectors of the population. The company failed to factor in all necessary factors in the test population of vaccine recipients in tis phase of clinical trials, hence, the vaccine, could prove to have serious side-effects on certain members of the population. And the vaccine itself might prove to have long-term side-effects for patients receive the inoculation which will only be discovered in years to come, as these health issues emerge in recipients of the dosages, if the vaccine indeed proves to have an adverse effect on any individuals health-status.
Patient received COVID-19 booster vaccine dose on 1/21/2022 at 14:30 at home, due to homebound status, by local Public Health Nurses.  On 1/22/2022 spouse of patient left patient at home alone in the morning to do some routine shopping, and upon returning home that morning, found patient had passed away.
pt recvd vax;subsequently devel a local rxn at inject site;tx w/ dph,apap & compress applied to the area;
over a year late getting his last dose; no additional adverse events; This spontaneous report as received from a pharmacist, referring to her 16 years old son. The patient's historical condition, concurrent condition and concomitant medication were not reported.   On an unknown date, the patient was over a year late got his last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, dose number, route of administration, anatomical location, lot# and expiration date were not provided) but had finally completed the series (inappropriate schedule of product administration). No additional adverse events reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), on 06Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid received from 11Mar2023 to 15Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.