chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via Social media concerned a female of an unspecified age, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JAN-2022 (a month ago from the reporting date), the patient got covid and was sick (suspected vaccination failure and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality complaint number: 90000217265. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220230241.  Version created to amend previously reported information on 24-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of  non-valid and LLT of event suspected covid-19 infection was updated from covid-19 to suspected covid-19).; Sender's Comments: V3:Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid and LLT of event suspected covid-19 infection was updated from covid-19 to suspected covid-19). This updated information does not change the causality of the previously reported events. 20220230287-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Systemic: Weakness-Medium, Additional Details: pt mentioned that she do faint after vaccins usually. we called the mom she was nearby location (she came in 5 min). blood pressure was10.05/5.6. we made her lie flat. then she drink water and eat salty chips. she was all right after 15 min.
Beginning a few hours after vaccine, developed low grade fever.  Continued for 3 days, then increased to 102 and began with mild headache.  Went to vaccine provider's office and given azithromycin for possible otitis media (very questionable diagnosis).  The following day developed severe, debilitating headache, which lasted for 5 days and resolved once he was off the azithromycin.
Patient reports experiencing hives, redness, and itching on neck and upper check starting 9/15/22 in the morning  and still being there on 9/16/22 in the morning when this RPh spoke with patient. The patient's physician called in a Medrol 4 mg dose pack to take, patient has yet to pick up from pharmacy.
12/20/2021 - Came to ER with worsening Covid symptoms- c/o weakness/sore throat/diarrhea. Previous inpatient stay from 12/9 - 12/18, in with cellulitis and later became symptomatic with covid pneum - tested on 12/14 - treated with Remdesivir-5 days, antibiotics, and steroid. Still Thrombocytopenic and anemic with severe Leukocytosis. CRP 7. PaO2 of 70. Vitals WNL. On 2L O2 NC. New diagnosis of AML. Continuing Cefepimine and Doxy.  12/21 - WBC 65.4/Platelets 22. Received 2U platelets. Heparin held due to Thrombocytopenia.  12/22 - CT scan of lung concerning for consolidation. Still on 2LNC. Continuing antibiotic/steroid. Received 2 additional U platelets and 1 PRBC.  12/23 - Bone biopsy complete. Thrombocytopenia likely due to underlying Leukemia. Treatment pending result. Worsening hepatic dysfunction AST- from 138 on adm to 270, ALT from 76 to 200.  12/24 - One IV ripped and bled significantly. Patient unresponsive for 30 seconds trying to move from commode to bed. Rapid called. 2U PRBC and 2U platelets ordered HCT 26.2/HGB 7.8. Moved to CVICU. O2 at 98 on 4LNC.  GI consult indicates liver injury likely due to Covid liver, underlying sepsis, and potential drug induced from antibiotics. Indicates there is no specific treatment at this point for liver injury. Antibiotics continued for sepsis/pneumonia.  12/25 - Liver functions stable. Conservative management and supportive care contnued. Pulse 124, RR 29, all other vitals WNL. Transfusion support continued for AML. Biopsy report pending. 12/26 - NG tube attempted by nursing. Patient began to bleed and struggle. Attempted a 2nd time. Tip unable to be verified and left in place. Questionable blood aspiration. Developed fever overnight >104 - 103.2 - Tylenol given w/o relief. Transitioned to Palliative care for overall poor prognosis.  12/27 - Patient expired @2125
Post procedural pain; Back surgery; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (Back surgery) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received first 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) Citrate Free. In April 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In November 2021, the patient experienced SPINAL OPERATION (Back surgery) (seriousness criterion medically significant). On an unknown date, the patient experienced PROCEDURAL PAIN (Post procedural pain). At the time of the report, SPINAL OPERATION (Back surgery) was resolving, PROCEDURAL PAIN (Post procedural pain) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medications were reported.  In Apr-2021, the patient experienced injection site hurt with second dose of covid-19 vaccine which was resolved on unknown date. In Nov-2021, the patient underwent back surgery. On an unknown date, the patient experienced back surgery pain.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna were missed to be booked-in No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 64-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Spinal operation, which occurred approximately 7 months after the second dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 64-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Spinal operation, which occurred approximately 7 months after the second dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) 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 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 VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
This spontaneous report as received from a pharmacist refers to her 70 year old mother. Approximately on 02-MAY-2013 the patient was vaccinated intramuscularly with a dose of ZOSTAVAX (dosage and lot# not reported) at an unspecified physician office. Approximately on 02-MAY-2013, the patient developed a bruise at the injection site which was resolving without requiring medical attention. There was no treatment given for the event. There were no lab diagnostics studies performed. Additional information is not expected.
2/9 - Extremely sore arm at injection site. Awoke with vertigo and dizziness which seemed to subside somewhat as day progressed. Also had low temp 99.1 on/off throughout day and sluggishness. 2/10 - Arm still sore. However awoke again with vertigo and dizziness along with very stiff neck and neck pain that got progressively worse as day progressed.  Called my family doctor late morning to report and get direction on what OTC meds I could take. Doctor returned my call after hours and recommended I go to ER to get checked and rule out meningitis since that can sometimes be side effect of vaccines with similar symptoms. ER doctor said he thought  since I had Covid back in March and April of 2020, I probably still had antibodies and my immune system was fighting off the vaccine, resulting in the viral symptoms I was having. He told me I could return to taking Mobic and Tylenol (that I had been taking up to 3 days prior to vaccine) and also gave me a RX for Meclizine for vertigo.
Tingling, subjective SOB. lasted less than an hour. Recurred iwth second dose. No treatment needed.
The 6+ months influenza vaccine was given to a 30-minute old neonate in error. Infant monitored and was afebrile for the next roughly 40 hours.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M020103 with expiration date 15-FEB-2018 (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 11.8 degrees Celsius for 1 hour 3 minutes. Data logger was involved. There was previous excursion of 10.2 Celsius for 1 hour 3 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer and described the occurrence of fever in a 2-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). The reporter is the mother of the subject. A physician or other health care professional has not verified this report. Medical history included breast feeding. On an unspecified date in June 2005, the subject received the 1st dose of Pediarix (lot number not provided). On the same day, the subject was also vaccinated with Haemophilus influenzae type B conjugate vaccine, measles, mumps and rubella virus vaccine (MMRII) and 7-valent pneumococcal conjugate vaccine (Prevnar). The consumer reported that the subject received these vaccinations, "in both hips." The mother also reported that, "in the middle of the night after having the immunizations," on an unspecified date in June 2005, the subject "spiked a high fever of 103 degrees Fahrenheit. He was also very sleepy and would nut nurse. He slept most of the following day." The subject was treated with paracetamol (Tylenol). The events resolved on an unspecified date in June 2005.
Persistent fever, sleeping a lot fr about 2 hrs post vax; temp 101-103; Had 2.5 x 2.5in induration & redness @ inject site rt thigh (DTP) small one on the other thigh (PROHIBIT);
The shot was administered on October 8, 2008.  Within two days I developed a persistent, hacking, and non-productive cough and both knees started aching.  Over five weeks later I still have a debilitating cough which seems to defy treatment and diagnosis and is worse at night.  I do not respond to any cough suppressant remedies such as cough syrup with codeine, cough drops, benzonatate and azithromycin.  An x-ray was clear.  The knee pain has thankfully lessened.
soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site pain. In November 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient had received the a dose of Shingrix vaccine, unknown arm and he had soreness at the injection site which has resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236518:same reporter
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 10:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 10:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.24 for dose administered on 27-Feb-2021 . No concomitant medications were reported. On 24-Feb-2021 , the vaccine with batch number 014M20A was moved to fridge. On 27-Feb-2021, 20 vials were moved to the clinic. On 27-Feb-2021 at 9 a.m to 5 p.m, vials underwent temperature excursion with temperature of 33-35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Mar-2021. Total 199 doses given for the day for batch number 014M20A. Temperature excursion was reported for cooler 1 of the device. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received Moderna COVID booster shot on 12/15/2021. She experienced redness and tightness similar to a sunburn. This resolved in two weeks. The patient said she experienced the same reactions again on 1/4/22 but with added swelling by the eyes. She did not experience any extraordinary adverse reactions from the first and second full Moderna COVID vaccines. I asked patient if she receives dermal fillers and she said yes.
Heart rate double my normal rate even while sleeping, blacked out and fell when I got up. Heart rate persistently above 110 when at rest for 7+ hours, didn?t come down until an ER doctor massaged the vagal nerve, then it dropped to near normal and stayed down.
SCAR/KELOID PAIN; SHOULDERS AND ARMS BURNING; SHOULDERS AND ARMS STABBING; FLU LIKE SYMPTOMS; SEVERE PAIN IN ARM; JOINT PAIN/ SEVERE PAIN IN SHOULDERS; SHOULDERS AND ARMS TINGLING; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stomach cancer, surgeries, and wounds, and other pre-existing medical conditions included: Patient had No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced scar/keloid pain. On MAR-2021, the patient experienced shoulders and arms burning. On MAR-2021, the patient experienced shoulders and arms stabbing. On MAR-2021, the patient experienced flu like symptoms. On MAR-2021, the patient experienced severe pain in arm. On MAR-2021, the patient experienced joint pain/ severe pain in shoulders. On MAR-2021, the patient experienced shoulders and arms tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on APR-2021, and had not recovered from severe pain in arm, joint pain/ severe pain in shoulders, scar/keloid pain, shoulders and arms tingling, shoulders and arms burning, and shoulders and arms stabbing. This report was non-serious.
Developed a 3 inch x 4 inch rash at the injection site that was red, tender, and warm to the touch. Physical exam only.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298676, 2018SA298677, 2018SA298678, 2018SA298675 and 2018SA298674, same reporter. This case involves a 44 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, family history were not provided. No other vaccines were administered. On 25-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA, expiry date 15-May-2019 via intramuscular route in the left arm. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 44 years patient was inadvertently administered FLUZONE HIGH DOSE. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender- none.
body aches.  Headache, sharp pain in head.  Fever of 100.4.   Chills.  Shaking.
Pt recvd vax 20APR92 & shortly p/vax pt turned red, got agitated & fell asleep; that evening p/awoke pt had urticaria all over body; also wheezing; taken to ER tx DPH;
dizziness, ear fullness after 10 minutes from getting vaccine. 125/79,76,98% drank some water and stated felt better, refused transport to ED
Pain in arm and shoulder, swollen, red, hurts to lift anything above head. Motrin. Vaccine givein in rotator cuff.
Right thigh edema, redness and heat. Patient states it is painful to bear weight on his right leg also. Dr evaluated with ultrasound-revealed no hematoma or clots. Performed labs. Offered supportive care.
temp of 103, mom said 104, gave advil, bathed over 24hr;
I felt sleepy and achy after the vaccine and slept a lot after the vaccine.  I started feeling systems of Covid 19 on June 11. Prior to June 11th I felt very fatigue. I was traveling a lot and just felt like I over did it. I started feeling the sore throat and nasal drip.  I took a home test for Covid 19 and it was positive on June 11. I took Flonase, Tylenol severe cold/night and alternated with Mucinex. Sore throat went away after two days. The congestion continues to today. The worst days was three and four days after tested positive. I had a telemedicine with a provider and they prescribed Paxlovid.
Patient felt faint, sweaty and dizzy right after receiving injection (per husband, she always felt same after vaccines.) Patient sit down then within 5 minutes she had to lie down. We provided cold compress and water, then she was able to sit down. After 25 minutes she felt better and left with husband who was also vaccinated.
Case number PHEH2013US024155 is an initial spontaneous report received from a nurse on 15 Nov 2013. This report refers to a female patient of an unknown age. The patient's medical history and concomitant medications was not reported. The nurse reported that one of her co-workers while withdrawing a dose of FLUVIRIN (batch number: not reported) from a multi-dose vial into a syringe, some of the vaccine sprayed into the patient's eye on 15 Nov 2013. No adverse event was reported following the maladministration.
First, felt unusual fatigue.  Then sore throat, watery eyes, coughing.  Nausea began around 5:00PM, then vomiting and diarrhea (severe).  Early morning (Approx 3:00AM) on 12/05/2011 woke with severe itching behind both ears and front of neck; welt-like masses in those areas.  Received no "treatment" for any of these symptoms.  All are resolved as of today except some residual itching/ discomfort anterior neck.