chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had been administered dose while the temperature excursion assessment was ongoing; patient had been administered dose while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing) in a 45-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Open wound on R wrist following fall in parking lot. C/O pain (mild) to R lower extremity  Dressing applied to small open wound on R wrist. Elevated above heart. Bleeding controlled. Vaccination completed in triage area.  Patient's husband fell on way into clinic on sidewalk. Patient fell on top of her husband. Sustained injuries as described.  Home by self and husband in own car escorted to car
Pt had blood in stool today, no fever, no vomiting, spitting up more frequently.
Presently, multiple small itching spots on feet, legs, arms, back, and stomach.  Most severe on the back.  None on face, head, hands, crotch, or neck area.  Began with a few spots on the legs.  Gradually spread to other areas as described.  Presently using Caladryl to relieve itching.  Tried using Coraid 10.  My vaccine was for shingles.
Tachycardia 140 high BP 155/100  extremely hot ekg done resolved in a day
Per mother's report: 7 hours after immunizations were administered, the patient spiked a high fever and presented with red welts over her entire body to the ER.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Within 24 hrs, pt became lethargic and almost unresponsive, slept thru feedings-hardly arousable for next feed. Afebrile throughout episode. 36hrs after went to ER-sepsis work-up negative. Lethargy and low arousability continued for total of 48 hrs. In am of 04/21/2002 more alert and playful, acting more normal and eating.
Patient received Johnson Johnson COVID vaccination on March 5th (Its not listed as an option for me to choose - Hence Janssen).  Two weeks later patient and wife described symptoms of significant abdominal pain and headache, which improved after 24 hours, since then, abdominal pain on and off with worsening, nausea vomiting and diarrhea.  Presented to Hospital with sepsis, negative evaluation, possibly GI etiology, given symptoms.  MRI of the abdomen shows left portal vein thrombosis/which is an unusual site.  Patient has no liver cirrhosis or metastatic cancer.  Is being investigated for idiopathic or acquired thrombophilia
Returned 2 days after injection with c/o pain at injection site area swollen and warm to touch. Two areas of redness at the injection site 30 mm each.
Started chills at 11 pm...At 3 AM chills subsided as I warmed up with a 100.4 fever...took Tylenol fever gone by 6 AM.
Nov 3 (wednesday) 4:40 PM -  Vaccine  Nov 4 (thursday) 2:30 PM -Headache (5 out of 10) 7:00 PM -Temp was 99.7 F; Ibuprofen 12.5 ml   Nov 5 (Friday) Persistent headache (5-8 out of 10) Fatigue 7:00 AM -Temp was 101.2; Ibuprofen 12.5 ml 1:00 PM -Temp was 101.9 ; Tylenol 12.5 ml 4:00 PM -Temp was 98.8 7:00 PM -Temp was 102; Ibuprofen 12.5ml  Nov 6 (Saturday) Persistent headache (5-8 out of 10) Persistent Fatigue 8:00 AM - Temp was 102.5; Tylenol 12.5 ml 11:00 AM -Temp was 100.2 1:00 PM - Temp was 102.8; Ibuprofen 12.5 ml 3:00PM -Stomach ache and vomiting 5:00 PM -Temp was 103.7 7:00 PM -Temp was 104; Tylenol 12.5 ml 8:00 PM -Stomach ache and vomiting 11:30 PM - Temp was 104; Advil 12.5 ml  Nov 7 (Sunday) Persistent headache (7-9 out of 10) Persistent Fatigue Persistent Stomach Ache 7:00 AM -Temp was 104; vomiting 9:00 AM - Brought her to facility; Temp was 104.2; Given Zofran and Ibuprofen 15.5 ml; Negative for COVID PCR, Strep and Flu; BP was 90/52; WBC=12.6; RBC=12.9; Platelet = 301; CRP=8.8; ESR=31; Because of history of Covid in Dec 2020 and low diastolic and increased inflammatory markers, was advised by Urgent Care to proceed to hospital ER for immediate assessment. 1:20 PM -  Hospital ER; Temp  bedside cardiac ultrasound by ER Physician and findings were normal. Troponin level was <0.015. Sent home with prescription for Zofran. Advised to seek consult with Pediatrician in 2-3 days if no resolution. 10:00 PM- Temp 104; Ibuprofen 15.5ml  Nov 8 (Monday) Persistent headache (3-6 out of 10) Persistent Fatigue 7:00 AM -Temp 104; Zofran x1 ; Tylenol 15 ml 11:00 AM- Temp was 99.8 3:00 PM -Temp was 103.8; BP=90/60; Ibuprofen 15.5ml 8:00 PM -Temp was 101.7; 11:00 PM - Temp was 103.5; Tylenol 15 ml  Nov 9 (Tuesday) Headache is minimal (1-2 out of 10) Persistent Fatigue 7:00 AM- Temp was 97.7 1:00 PM - Temp was 99.2
Swelling, pain and warm/hot to touch at the site of the injection s throat dryness, tiredness I have had no reaction until today 5/08/21
Case received on 12 October 2011 from a healthcare professional. A 46-year-old female had received on 11 October 2011 her yearly intramuscular dose of FLUZONE (batch number UH442AB) and her dose of PNEUMOVAX (other manufacturer, batch number 0985AA). There was no other vaccination within 4 weeks prior to 11 October 2011. Other medications were unknown. The patient had no illness at time of vaccination. She had a medical history of allergy to AROPAX. On 11 October 2011, 3 hours post-immunization, the patient developed nausea, vomiting and dark green drainage from eyes. The patient treated herself with eye wash and compresses. The reporter stated that the patient reported that symptoms resolved overnight. Documents held by sender: none.
Chills, rash at injection site that was burning & itchy for about a week. It is still red like a rash at the site but there is not pain or itchy anymore.
pt recvd 1st dose of Hep B vax 22APR92 & devel a rash on arms, legs & buttocks; rash was described as small red bumps & was pruritic; devel a fever 13MAY92; joints were swollen & painful; dx still's disease;
I began to experience headache and slight fever (99.6) at approximately 6 PM on Thursday, 9/2, along with soreness at the injection site.  These symptoms persisted the following day at which time I began experiencing general muscles aches all over my body, similar to a flu, as well as chills and chest pains on the evening of 9.3.  However, all symptoms had resolved by the time I woke on the morning of 9.4.
Palpitations, tachycardia, anxiety several hours after vaccine while at home after awakening from a nap.  Resolved after 2 hours.
Pt devel GBS p/receiving influenza vax; sx included numbness & tingling in hands, feet, & lt side of face; weakness in limbs; & elevation in BP; pt hospitalized on 24NOV90 & treated w/meds;
I had my second shot on Saturday, April 10. The next day I awoke to breathing issues that went away in a few hours. On Thursday, April 15 the breathing issues returned. I started nebulizer treatments that Thursday and a Prednisone 10 mg dose pack the next day. After four days on Prednisone, I was not getting any better and went to see my pulmonologist who prescribed me Amoxicillin and gave me a steroid shot. After ten days on Amoxicillin, the breathing issues have not resolved, and I am still needing nebulizer treatments. Saw my allergist today who recommended I see my pulmonologist and cardiologist.
The next day 24 hours later I started getting heart palpitations. I thought I was getting heart attack afternoon at 5:00PM. I went to the local urgent care clinic. They got me a heart monitor for three days. After that they found out I got PVC/PCA. After I went to heart institute they told me that my heart was fighting with too many infections. It was over drive. They told me that I have to live with it.
I took the shot whenever I stood up and moved, I would get out of breath. I had a cough and chest pressure and it is still happening doctor prescribed Adderall.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately January 2016, reported as on multiple unspecified dates following a temperature excursion reported on 15-JAN-2016, the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX injection (lot# L003774, expiry date 04-FEB-2017; lot# L020000, expiry date 02-JUN-2017 and lot# L030160, expiry date 11-AUG-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. The reporter stated that the doses of (Oka/Merck) VARIVAX were exposed to the temperature of 6.1 degrees Fahrenheit for a period of 70 hours on an unknown date (with previous temperature excursions: 5.9 degrees Fahrenheit for 15 hours, 6.8 degrees Fahrenheit for 48 hours, 5.5 degrees Fahrenheit for 72 hours, 6.8 degrees Fahrenheit for 15 hours, 6.6 degrees Fahrenheit for 120 hours, 5.9 degrees Fahrenheit for 72 hours, 5.2 degree Fahrenheit for 16 hours and 6.1 degrees Fahrenheit for 70 hours-on unspecified dates). This is one of several reports received from the same reporter. Additional information has been requested.
The patient had extreme tiredness for 2 days post vaccination and  her arm around the injection site became red and itching with a large white lump  at injection site that is still present as of today (3 days post vaccine).
8 days post second vaccination developed severe frontal headache, lethargy, altered view state. Sympt. initially were getting progressively worse. Was seen by neurology at hospital. Eval dx with immun. encephalitis.
(L) lower thigh with redness\induration measures 20 cm warm to touch under injection site by 3cm no other visible open wounds. AMOXIL, warm compress.
Information has been received from a health professional concerning a 16 year old female patient who on 13-MAY-2007 was vaccinated with a dose of Gardasil. On 13-MAY-2007 the patient fainted. The reporter mentioned that 2 weeks later the patient fainted again while sitting down. Subsequently, the patient recovered. Additional information has been requested.
Case number PHEH2014US003616, is an initial spontaneous report from a pharmacist received on 21 FEB 2014 and follow up report received from the pharmacist on 18 MAR 2014. This report refers to a 15-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010021A, expiration date: JUNE 2014) at a dose of 0.5 ml intramuscularly in the right arm on 06 DEC 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up report received from the pharmacist on 18 MAR 2014. The vaccination site of FLUCELVAX was updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 18 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
she got sx 29Dec22 and tested positive 05Jan22; she got sx 29Dec22 and tested positive 05Jan22; cough; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from regulatory authority.  A 33 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 04Nov2021 (Lot number: FF2589) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 02Mar2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 23Mar2021, when the patient was 33 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "she got sx 29Dec22 and tested positive 05Jan22"; COUGH (non-serious) with onset 29Dec2021, outcome "recovering", described as "cough". The event "cough" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: covid test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of cough.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event covid19, vaccination failure and immunization cannot be totally excluded.
Patient was administered the Covid19 vaccine.  She was advised to wait 30 minutes post vaccination.  While the patient was waiting, she reported having an itchy throat, throat tightness, then a hoarse voice and a cough developed. This happened at about 20 minutes after she received the vaccine.  The patient was assessed by the nursing and provider staff.  She received an adult epi pen injection and EMS was called. Patient was taken to the ER by EMS.  She reports she received two more epi injections, benadryl, and Solu Medrol. She was stabilized.  Patient was discharged from the ED after several hours.  She then reports a second episode of throat tightening and worsening cough at 12:30 am and was taken by ambulance to the ICU and admitted.  She is still in the hospital at this time 12/22/2020.
Patient had injection site reaction - site was hot and itchy. Patient also said it was hot and itchy also up that side of her neck as well. Pt said she would also take some BENADRYL to help with the allergic reaction. Started about 6 hours after initial injection.
PATIENT HAD FEVER OF 101, CHILLS, RASH PROGRESSED, DIARRHEA AND UPSET STOMACH WHICH ALL STARTED THE DAY AFTER
why his arm has a magnet after having the Pfizer Covid-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "why his arm has a magnet after having the Pfizer Covid-19 Vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Unbearable pain in should joint; No OTC medications help. Limited range of motion still, 48 hours after injection. Cannot lift over head or behind me without excruciating pain and I had FULL function of my arm prior to this injection.
My arm immediately hurt at injection site. Later that evening my arm swelled and was more painful, all the way down to my elbow.  I took Ibuprofen In the night while I slept my arm swelled more and became even more painful and swollen, all the way down to my thumb. I took Acetaminophen. In the morning I had an upset stomach and diarrhea (that lasted  off and on for over 3 weeks), but the pain and swelling eventually subsided within 3 days.
On 9SEP had flat, red rash on face & torso on 7SEP had 100.6 temp PO; On 30AUG91 upper arm started swelling on 3SEP91 had flat, red rash surrounding inject site;
Patient's upper face went numb for 5 days. After going to the ED. She was informed that it was trigeminal neuralgia from the high dose flu shot. (right trigeminal nerve).
Legs felt heavy. Pain in knees lasting almost 2 weeks. Trouble walking. Symptoms starting to ease after 12 days.
Pt broke out in severe hives all over his body and pt had respiratory distress. It started on the following day at 10:30 PM and lasted until the morning when pt finally went to the E.R. around noon. Physician at E.R. gave pt Prednisone and ATARAX.
Fever headach nausea; Took tylenal and ibuprofen; No appetite bad taste in mouth
Swelling & redness to L deltoid felt warm to touch - no pain. ZYRTEC 3/4 tsp po given once a day for 3 days.
swelling of both legs thighs thru ankles onset following AM p/MMR/HIB/PPD @ clinic; t102.3;
I have been having severe headaches; dizziness since starting Rabies Vax, had to get pain medicine from urgent care due to extreme pain in head, then had a fainting spell on 19th in parking lot of a business, had to sit for over an hour before could drive. Luckily I was not driving at the time.
6000 patients reported paresthesia; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (6000 patients reported paresthesia) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (6000 patients reported paresthesia). At the time of the report, PARAESTHESIA (6000 patients reported paresthesia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
I had a friend come to visit on September 2 and he was coughing and hacking, but he said it was from harvesting corn. He stayed with me September 2-6, and on September 6, I felt super tired. On September 7 and 8, I was extremely tired. By September 9, I started coughing and on September 10, I got tested and tested positive. On September 11, I got the subcutaneous antibody injections in my stomach. That morning before the antibodies, I was in the shower and noticed I couldn't smell anything, and I tried smelling everything, even a bottle of bleach and couldn't smell it. I also had cough and chills that day, but I could taste. After the antibodies, I rapidly improved and got my smell back on September 14 and felt normal by September 15.
S/S started 10/13 PM, Rec'd flu vaccine in AM 10/12 - fever, nausea, dry heaves, chills. MD said she had a stage II flu reaction. TYLENOL for fever.
This solicited report was received from a physician referring to a 64 years old male patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2008, the patient was vaccinated with his first dose of ZOSTAVAX, one time injection, route of administration, lot# and expiry date were not reported). On an unknown date in March 2014, the patient went down with "mild case" of shingles that lasted approximately 3 days after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
Information has been received from a health professional concerning a patient (3 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site which was 3 inches in diameter and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site which was 3 inches in diameter and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
large 5 cm diameter area-red, hot & swollen lt thigh; local reaction to DTP; Keflex given;
This spontaneous report as received from a health care worker (also reported as clinic manager) refers to a 31 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated the patient was supposed to have received (Oka/Merck) VARIVAX but on 07-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque forming units (PFU)) (route, indication was not reported) in error and also mentioned that the error was not due to medication confusion. It was also reported that the facility does not routinely carry ZOSTAVAX, and one dose of ZOSTAVAX had been purchased for the physician's personal use. The reporter also stated that the patient was vaccinated with M-M-R II and hepatitis B vaccine (recombinant) (manufacturer unknown) (also reported as unspecified Hepatitis B vaccine) during the same visit. The reported mentioned that the patient had not demonstrated or reported any adverse experiences. The outcome of events reported was unknown. No product quality complaint was involved. Additional information has been requested.