chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 8:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 54.83 years.  Concomitant products were not provided.  On 31-Mar-2021, four vials were moved to clinic of batch number 019B21A. On 23-Mar-2021, the vaccines of same batch were moved to fridge and proposed beyond use date was 22-Apr-2021 for batch number 019B21A.  On 31-Mar-2021, at 08:00 A.M., the temperature recorded was 32 that has been reached by the vial.  The vials were only punctured right before administration and both the doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 Fahrenheit.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from a nurse refers to two unspecified patients of unknown age and gender. On 01-JUN-2015, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot number and expiration date not reported) dose, frequency, route of administration not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Info has been received from a CMA concerning a 4 year old female pt. On 7/13/05, while attempting to administer MMRII to the pt, she became difficult to control. The pt was held by her mother and her legs held by her brother. It was reported that the nurse attempted to give the vaccine and the pt moved. The needle scratched the pt's left arm and a dose of medication squirted into the nurse's eye. The MMRII was able to be administered to the pt. At the time of this report, the outcome of the event was unknown. Additional info has been requested.
Large amount of swelling in right thigh, this is injection site.  Not wanting to use leg, severely limping.  Pain, redness & swelling at injection site.  Enlarged lymph nodes at right groin, previously not enlarged prior to injection.  Nosebleed Friday 8/10/12.  Noticeable paleness & tiredness noticed to date.
Customer came in for a third Moderna dose with vaccination card showing she had received 2 doses of moderna. Upon billing, it was discovered that she received the J&J COVID vaccine. This was verified in information system. She withheld information to the pharmacy. She has not experienced any side effects that I am aware of.
By 8 p.m. patient's had a fever and a very sore arm. Her fever rose to 103.8, she was delirious, tachycardic and faint on standing. By the time she was at the ER at about 2:30 a.m. on 12/27 her fever was 105, her resting heart rate was 138. Treatments: rectal acetaminophen, IV toradol and beta blocker. Outcome: fever subsided after toradol, tachycardia lessened after beta blocker
This spontaneous report as received from a registered pharmacist refers to several patients of unknown age. The patients were vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that several patients had developed itching or burning after being administered the vaccine. No treatment information was reported. It was unknown if the patients sought medical attention. The pharmacist did not have any patient specific information. The outcome of itching and burning after being administered the vaccine was unknown. The relatedness for the reported event was for ZOSTAVAX. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
approx 1mo p/vax pt exp temp 104f a papular red rash w/no exanthem & 1-3mm lesion. disturbed sleep, head shaking. md noted looks like early chickenpox (mild)
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot #L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no date logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Blood Clot-Bad swelling in right arm. Arm tingling, numbness and discolored. Arm is swollen from top of arm to fingers. Notice first sign on Monday morning (04/12/2021) when i awoke from bed around 7:00am.
At 14:15, pt. called me (RN) to report she is "itching and my arm feels weird." Assessed to find Rt deltoid area reddened; warm to touch, edematous with some tenderness to touch. Area localized w/slight radiation to upper shoulder.
Fairly significant allergic reaction after the shot; This is a spontaneous case, reported by other non-health professional (consumer) to Company (reference number: SEQ20-00011) on 02-Jan-2020, concerning a female patient of unknown age.   The patient's medical history was not provided. The patient had never had allergic reaction to flu vaccine in the past. Last year the patient was administered vaccine with batch number 02944621A and no adverse reactions were reported. The patient's concomitant medications were not provided.  On an unspecified date, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 259814, dose, route of administration, anatomical location and expiry date: not reported] for prevention of seasonal influenza.  On an unspecified date, after the flu shot, the patient developed fairly significant allergic reaction. It was unknown whether the patient applied any corrective treatment for the event.  At the time of this report, the outcome of the event was unknown.  The reporter did not provide event seriousness. The reporter assessed the event of fairly significant allergy reaction as related to Flucelvax QIV.  Company comment: The event of fairly significant to vaccine is assessed as related to Flucelvax QIV.; Sender's Comments: The event of fairly significant to vaccine is assessed as related to Flucelvax QIV.
She reports feeling fatigued still. She was calling to see if she should get the second dose of the vaccine since her doctor advised her against the second dose because she had a headache and fever following her initial injection. She reports she discussed with doctor over the phone immediately following first vaccine but was not seen in person.
Induration and swelling 7x8cm on L deltoid noted on 28-30 H after injection.  Q fever given Robitussin and Albuterol for associated cough and wheezing noted as 32 Hp.
The patient received a dose of the COVID Vaccine at 15 years old because he is an employee of a LTC facility and the administrator didn't realize his 16th birthday was still a few months away. No concerning adverse events noticed.
Diagnosis of Bells Palsey  Aug 16.  Was prescribed steroids and an antibiotic.  No other treatment since first round of medications. Slack facial features, head pain behind ear, as of 30 Sep 2021 still cannot close right eye - sleeps in eye patch with eye taped shut.  Right side of mouth still affected.
Minor patient accompanied by her mother on 11/4/2022 and vaccinated by, RN.  Per, RN written report to Charge Nurse, RN as follows:  [Begin Report]  Child moved while injecting dose and unable to vaccinate as the needle once inserted came out following patient movement. Needle remained intact, zero vaccine was injected, and patient right thigh injection site appeared within defined limits upon assessment. Nursing staff, RN stayed with patient and Charge Nurse while vaccinating nurse sought assistance, RN and Site Supervisor, RN then made aware and they responded immediately. Needle assessed as intact by Site Supervisor, RN. Site Supervisor then spoke with the patient's mother about clinic policy of injecting in the opposite thigh for a second vaccination attempt. Patient mother verbally refused and stated that she only wanted her child vaccinated in the right thigh again for the second attempt. This vaccinating nurse able to successfully vaccinate child in right thigh. Family safely escorted to the post-vaccination area by Site Supervisor.   [End Report]  Per Charge Nurse, RN observation child had calm and playful appearance once seated with mom in the post-vaccination waiting area and began walking around the area safely. Patient safely walked out of the clinic drinking her juice with mom at 5:55pm. Mom thanked staff for their assistance in vaccinating her child upon clinic exit.
Palm-sized welt/swelling on arm at injection site with severe pain, rash on arm, swollen armpit, fever, fatigue, asthma exacerbation. The arm pain is almost as bad as labor.
1) Extreme tightness in chest but did not affect breathing.       This lasted 2 days.  2) Raised rash a 1/2 inch below injection site & the rash is 2"x2.5" in size & still present as of  8/2/2021.
Immediate flu-like symptoms within 8 hrs, including severe runny nose, sneezing, muscle aching, and abdominal cramping/loose stool. I was perfectly healthy preceding. This is an unacceptable form of influenza vaccination, now being req'd by military. Claims of "sometimes mild symptoms" reported now seems false, as with most that take this mist. It is most likely just under-reported! As I am now sick, I strongly believe it is easily spread to family members, more contrary evidence to the manufacturer claim that should be investigated, especially for those of us with small children/pregnant spouse.
TEMPERATURE EXCURSION; This spontaneous report has been received from licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 02-NOV-2020,  the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) formulation not reported but defaulted to subcutaneous injection, 0.5 milliliter, Lot # t006345, expiration date 20-FEB-2022 for prophylaxis (dosage regimen and patient route of administration were not reported).   The temperature was reported to had been at -13.9°Celsius (°C) to -14.7°C . For 30 minutes, the temperature was in between -14°C to -10°C (-13.9°C). For 15 minutes, the temperature was in between -14°C to -10°C (-14.2°C). For 20 minutes, the temperature was in between -14°C to -10°C (-14.7°C). For 5 minutes, the temperature was in between -14°C to -10°C (-14.6°C).There was digital data logger involved.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On unspecified dates in February 2016, starting on or after 04-FEB-2016, patients were vaccinated with an unspecified number of improperly stored doses of oral, ROTATEQ (lot # L013202 and expiration date 27-JAN-2017, dose was not reported). The temperature of the excursion was 46.9F with the time frame of 16 hours. There was no previous excursion and it was not a data logger. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Pt recvd vax & felt badly; 8NOV felt worse; 9NOV seen by MD-CXR-clear; adm to hosp 15NOV93 died-dx strep pneumonia;
Diagnosis Probable  Idiopathic Urticaria treated with Aatrax. 6 months post vaccination unknown cause of continual hive eruptions over the past 10 days . Multiple sites including Arms, Legs, Buttocks and face. Symptoms respond to antihistamine treatment but reoccur when medication is stopped. Currently on chronic antihistamine treatment as per physician.
I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the brain. I went to emergency at hospital with worst headache of my life. After a brain hemorrhage was confirmed by CT-scan, I was rush to hospital were I was treated in the Cerebral critical unit. I suffered through the worst pain of my life for 10 days as the blood from the hemorrhage drained. It 2.5 months later and I am still dealing with the effects of the hemmorhage (headaches, exhaustion, light sensitivity, short term memory loss and speech issues,
A company representative reported that a child, inadvertently, received a subcutaneous injection of Prevnar. Post vax, the child developed swelling at the injection site. No further information was available at the date of this report.
2hrs p/immun pt was fussy, shivering according to mom; APAP had been given once; Not feverish @ that time; rt arm sore; Next day t103 ax; hardly slept continuing to receive APAP & tepid baths; Seen by MD dx rt ear infect & began ATB;
Patient was advised after the Moderna vaccine to sit down for 15 minutes for observation. 5 minutes after sitting down, patient felt nauseous, went black out , where he described it as "brain shutting down" and having a "vivid dream for 30 seconds".  This last approximately 15-30 seconds.  After blacking out he was able to open his eyes , completely conscious and alert.  We offered him water and cracker and patient stated he felt much better, and declined 911.
After 15 minutes arm tingly + hurt went home + slept - 2hrs. later whole left side in horrible pain - 12hrs later some relief - next day call nurse- went to ER- concluded reaction to H1N1- week recovered.
Started with heat at the injection site, mild soreness when lifting arm,but withing 24 hours could not lay on that side, can not lift arm above shoulder ,pain wakes patient at night , Ice helps most . Today, 8/17 , the pain is the same, unable to lift her arm above her shoulder.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a health facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2016, the patient was treated at a health facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Gilliam-Barre Syndrome; paralyzes; Initial information received on 18-Nov-2021 regarding an unsolicited valid Social Media serious case received from a consumer non health care professional under reference .number: US-SA-SAC20211125000835.  This case involves an unknown age and unknown gender patient who experienced Gilliam-Barre Syndrome (Guillain-Barre syndrome) and was paralyzed (paralysis) after receiving vaccine INFLUENZA VACCINE..  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event Gilliam-Barre Syndrome (Guillain-Barre syndrome) and was paralyzed (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. The events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/ event.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case.; Sender's Comments: This case concerns an unknown age and unknown gender patient who experienced Guillain-Barre syndrome and was paralyzed after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
First COVID shot received March 14.  Daratumumab subcutaneous injection with oral dexamethasone received March 17.  Persistent continuous fever began March 19 which lasted 6 weeks.  Initial temperatures spiked over 102°F; could be temporarily reduced with Tylenol.  Administration of Daratumumab and Revlimid was suspended March 31 and resumed April 21.  Second COVID shot received April 13; very little reaction besides general tiredness.  Temperature peaks gradually decreased over the 6 weeks; temperature returned to normal week of May 3.
Date entered in date administered field is the date the allergy was documented by employee health. Actual date of administration is not known. Lip swelling; respiratory crackles.
sore arm; 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 62-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2021 as dose 1, single (Lot number: EW0196), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing), notes: Comments: Anxiety; "Depression" (ongoing), notes: Comments: Depression. Concomitant medication(s) included: FAMOTIDINE; SEROQUEL. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She has had 2 doses. The first was on 14Jul2021 (Lot EW0196), and the second was of 04Aug2021 (Lot FA7485) at (Name withheld). She stated that a nurse told her over the weekend that she should have gotten, Moderna because it has no side effects. She was told that Pfizer had side effects of myocarditis, then mentioned that she has a family history of heart disease, but that she never had issues with heart disease or blood pressure. It was unclear if she was implying that she was experiencing those issues. She was also asking if 1P36 deletion syndrome was related to the vaccine, as well as neuropathy and bowel issues. She stated that after the first shot, all she had was a sore arm, then stated that she got it in her left arm, where there was also a nicotine patch. No follow-up attempts are possible. No further information is expected.
Patient had a syncopal episode after receiving his vaccine. Fell and abraded his forehead. Symptoms resolved. Evaluated by myself and paramedics. Declined further evaluation or transport to a hospital. Appeared competent to decline. Wife to take home. Instructed to call ED if worsening symptoms. Interactions were assisted by a fluent staff member. Patient relays a history of multiple syncopal events after receiving injections. Normal vitals at time of exit from facility. Ambulated under own power without signs of distress. Up to date on tetanus vaccination
A couple hours after administration of vaccine patient started experiencing lightheadedness and took a shower then felt like she was going to pass out. She also complained of chills in ER. She was seen by PCP the next day and she reported body aches, hot and cold sweats and head pain. Was given dose of Toradol in the office for pain symptoms.
Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a female patient of unknown age who received first dose (post exposure) on 17-Jan-2019, second dose on 30-Jan-2019 and third dose on 15-Feb-2019 of vaccine, IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported whether adverse event was experienced by the patient. 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 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.