chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. The patients pertinent medical history was not reported. On an unknown date unspecified patients were vaccinated with a supported dose of PROQUAD (Merck) (dose, lot number unknown). No adverse effect was reported. No product quality complaint (PQC) was reported for PROQAUD (Merck). This case is one of the several reports linked with same reporter link. Additional information has been requested.
Headache beginning 2/9 around 16:30 with nausea beginning 2/10 am.
A "few drops" of Moderna COVID 19 vaccine leaked onto patients arm due to needle and syringe not tightened enough.  RN states a few drops, a few times during administration.  Confirmed that less than 0.1 ml leaked out.
Event:  "Delayed Cutaneous Hypersensitivity" or Lay Term "COVID arm".  Symptoms at Injection Site: Itching, 3-inch high by 2-inch wide rash, slightly elevated surface temperature.  Elevated Surface Temperature: Determined by Exergen temporal thermometer on 2/5/2021 with surface temperature readings of 99° on temple, 97.9° on upper right arm and 99.2° on upper left arm injection site.  Treatment: No treatment of symptoms undertaken.  Outcome: Symptoms subsided without treatment.  Start of Symptoms: 2/3/2021 or 6-days after Dose 1 injection.  End of Symptoms: Itching subsided on 2/6/2021 or 3-days after Start; Rash had (see Continuation Page...)Additional information for Item 18: 99% subsided on 2/12/2021 or 9-days after Start.
Within 30 mins of IM HTN 160/107. Two hours before BP returned. Full body Bone pain and fatigue through out body 2 days following however on Monday 9/13/21, bilateral wrists, forearm, hands stiff and pain. Wrists swollen, bilateral thumbs arthritic and painful during movement. Right thumb dislocates intermittently. HTN INTERMITTENTLY would rise above 160/100. Past 30 days still HTN higher than 160/100 still with 2 ER visits since BP elevated above normal and uncontrolled. Headache and vertigo has increased daily. Per ER doc idiopathic BP. Multiple labs cbc, cmp, CT brain, cxr, CT angiogram mostly WNL. So idiopathic. Hands difficult to use
Injection site red, warm to touch, and lump under injection site. Cool compress applied. Injection site remains red, lump is smaller, and injection site remains warm to touch
I felt anxious and like I needed to stretch most of the night. Didn?t sleep at all. Severe body aches and sour stomach or about 18 hours after they started. Lingering headache
Bladder is out of order; Going to bathroom every 10-15 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Trouble hearing" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POLLAKIURIA (non-serious), outcome "not recovered", described as "Bladder is out of order; Going to bathroom every 10-15 minutes". The event "bladder is out of order; going to bathroom every 10-15 minutes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pollakiuria. Additional information: The patient stated that treatment received was approved and prescribed by doctor and that the medication was not really working.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Puritic Maculopapular Rash of the neck. Suboccipital and postauricular lymphadenopathy.
At 1:00 am on Monday 4/4/2022, I began to have extreme vertigo, nausea and vomiting, racing heart and feelings of dread. These lasted on and off for about three hours and then passed. On Friday morning, 4/8/2022, I did not feel well and my PCP is on maternity leave so we went to a local Urgent Care facility. They took an EKG and sent me to the hospital, free standing ER. There, I experienced runs of SVT (2-20 beats) and extremely high BP (up to 215/150) which I've never had before. I was treated with IV hydralazine, a calcium channel blocker (cardizem) and transferred/admitted to hospital for two days. I experienced headache and nausea while there and was discharged Saturday 4/9/2022.
While watching wife had severe allergic Rxn to flu shot ( and 10 min after her flu shot) Pt vasovagal syncope on chair and progressed  to full arrest.  No additional information from Medical Record rec'd 01/25/2006/sr
I had sinuses, congestion, headache, sore throat, and diarrhea. On December 22nd I went to the doctor and found out I had Covid.
Angioedema; Difficulty breathing; A spontaneous report was received from a pharmacist, concerning a 68 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced angioedema and difficulty breathing (dyspnea).  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 04 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection.   On 16 Feb 2021, approximately 12 days after receiving vaccine, the patient was hospitalized for angioedema with swollen oral cavities, swollen lips and difficulty breathing. He was treated with diphenhydramine, famotidine and methylprednisolone. The patient was discharged from the hospital on 19 Feb 2021. The patient did not have any changes in his diet or at home medications.   Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of events, angioedema and difficulty breathing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of these products and the start date of the event, a causal relationship cannot be excluded.
Administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Btw 2 & 4 pm  flashes of heat/pain  in  my right leg and legimate pain in my left leg,was constant for abt 2 hrs.  So paineful could NOT move for abt 2 hrs.  Able to drift off to sleep about 6 AM  6:30 am TEMP was 98.9   Finally got up abt 11:00 am with slight headache. Temp at 11:30 am was 98.7   Was completely "wiped" out .  Rested the whole day and evening, drinking hot tea and oyster crackers. that eveing very well, about 6 hours.  Saturday @ 12:pm Temp was 96.3 about right for me!    My observation:  Needed to Hydrate BIG TIME, before and after 2nd vax!
Grey limp unresponsive episode 4-6 hrs post imunization requiring ER evaluation.
Initial and follow-up information has been received from a physician concerning two female patients (ages and genders unknown), who, on unspecified dates, were vaccinated with doses of Gardasil. Concomitant vaccinations included "four unspecified vaccines" [therapy unspecified]. Subsequently, the patients experienced high fevers and flu like symptoms. It was reported that "one patient's symptoms were a little bit worse than the others." The patient were seen by the physician. The patients recovered on unspecified dates. No product quality complaint was involved. Follow-up information indicated that a health care professional reported that she could not remember who the actual patients were, just that there were two of them. She reported that their records are all electronic so she would not have any way of looking it up easily. Additional information has been requested.
.Mandatory EUA Reporting - Received 2nd Moderna Covid vaccine on 2/26. Admitted to hospital on 3/10 with pneumonia and COVID positive. Patient's son was living with him and Covid positive. Failed treatment with abx, steroids, oxygen. Transitioned to comfort care and passed away on day 8 of hospitalization.
2 weeks after the first dose  Awful pain and stiffness in both hands. went to DR on 4/12 did blood work diagnosed with RA. Did not think about the vaccine until two weeks after the second dose I struggle to walk with severe pain in my legs, arms, and hands. Life since has been pretty rough passed out from the pain on May 16th had to have 9 staples in my head. Now my life is trying to balance medication so I can sleep at night. And get through the days at work. I have had to miss days.
Moderna COVID-19 Vaccine EUA Client requested  and received 1st dose of the Moderna vaccine.  It was found out after the 1st dose of Moderna was administered on 8/27/21 that the client had received the   J & J Janssen  vaccine 5/8/2021..  No adverse reaction reported or noted.
It started with a rash on my chest that lasted a few days and went to my back. It keep moving around it went to my neck behind my ears to my scalp. Once I have it cleared it it moves to a new location. I t was also on my face as well. As of now I got my right ear covered in rash and a little on the back of my neck. The worsen part of now is that it on my scalp.
4/8/2021 3:00pm, 1 hour after vaccine stomach ache, drowsiness, and dizziness/lightheaded 4/8/2021 8:00pm, 6 hours after vaccine numb tongue, swollen face - allergic reaction -- took 1 25mg Benadryl 4/8/2021 10:00pm, 8hours after vaccine swollen face, throat tightness, swollen face, sore throat- allergic reaction -- went to ER given Pepcid, Benadryl, and steroid -- also prescribed these items for next 3 days.  4/9/2021 6:20am - following morning lips swelling - took 1 25mg benadryl
Received vaccines on 09/04/2019.   At 9 am on 09/05/2019 mother woke baby and noted red rash left thigh.   Arrived to office and rash had spread over body.   Diagnosis urticaria.   No wheezing, coughing or difficulty breathing.   Playing as usual.   No recent change inn soaps lotions, detergents,etc.   Dad sprayed Febreeze on their bedding last night when cleaning but father comments baby exposed to the same Febreeze when 3 yo sprayed it on him before and no reaction at that time.   Mild reaction at visit - parents counseled t observe for signs of anaphylaxis and present to ED if noted.   Prescribed Cetirizine HCL 5mgm/5ml oral solution - take 2.5 ml daily prn rash and itching.
pt recv vax;golf ball size swelling/redness at inject site;inc fever 102;n & v;
Got ours shots several years ago / got shingles again / have had them three times/spected vaccination failure; Got ours shots several years ago / got shingles again / have had them three times; This case was reported by a consumer and described the occurrence of suspected vaccination failure in an unspecified patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. It was reported the patient shots several years ago and still got shingles again, had them three times. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Guillain-Barré syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received MMR (MMR vaccine) for prophylaxis.   On an unknown date, the patient received MMR vaccine. On an unknown date, an unknown time after receiving MMR vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barré syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to MMR vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to MMR vaccine.   Additional Information: GSK receipt date: 17-Mar-2023 The case was received from the patient's parent via interactive digital media. The reporter stated that they said you can get guillain-barre syndrome from it. That's why the reporter was afraid of the shot. The patient got them from the MMR vaccine and so not sure the reporter want to chance it. The follow-up could not be possible as no contact details were available.
Information has been received from a medical assistant referring to a patient of an unknown age and gender. On 14-JUL-2016 the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not reported). On 14-JUL-2016, the patient received the second dose of GARDASIL (route, lot # and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Patient's left arm swollen on Sunday AM. Whelp present size of a silver dollar. Monday, 8/27/12, mom took child to MD, as child had "pus filled" pockets on arm and did not want to raise the arm. Was told area may have to be lanced. MD treated with 2 antibiotics and per mother said it was from the needle used to vaccinate.
After leaving vaccine site, patient felt throat swelling. She took Benadryl herself and felt relief.
On Sunday, March 21, my left arm, just below the vaccine injection site developed a red, slightly swollen area. It is approximately 5cm by 6cm in size and does not appear to be changing size. It is slightly red, slightly swollen, and warm to the touch. It is not tender or itchy.
alternating fever and chills, loose bowel movements, vomiting  lasted about 3 hours
pt recv vax 10AM on 24OCt97 @ noon devel vomiting, diarrhea & fever 102;
states had sudden onset flushing  from chest to head, increased pounding heart rate, difficulty swallowing, tightness, numbness in throat, extreme anxiety, approximately 45 minutes after vaccine lasted 5-10 minutes, however the swallowing issue lasted  2-3 hours  States did not seek medical treatment, symptoms resolved on their own
August, 2021: New onset unilateral tinnitus and partial sensoneural hearing loss. ENT consult: 3 week prednisone course. MRI r/o tumor, and document hearing loss. November 22, 2021: Received booster dose of Pfizer COVID-19 vaccine. November 24, 2021: Acute exacerbation of tinnitus and decreased hearing. No other neurologic symptoms or signs. November 24, 2021: Consultation with primary ENT via telephone and patient began short course prednisone 60 mg per day (taper to be prescribed). March 10, 2021 - first COVID-19 Pfizer dose; March 31, 2021 - second COVID-19 Pfizer dose
Patient was given vaccine at 10am.  Patient started having an itch and numbness feeling in her throat about 10-15 minutes after the covid-19 vaccine was given.  She was given Benadryl 25mg liquid (10ml).  Vitals were taken and normal.  Her tongue was not swollen.  She started to feel her throat swelling.  an additional dose of benadryl was given (75mg in 30mL) for a max total of 100mg.  EMS was called.  EMS arrived about 10 minutes later.  She was feeling better and declined EMS trip to the hospital.  She was observed for 15 more minutes and left home.  Her husband was the driver and will continue to monitor her all day. They were both educated to continue watching for any throat swelling, tongue swelling, difficulty breathing, etc.  Educated to call EMS is she has any new or worsening symptoms.  Educated on contacting her PCP about the 2nd covid-19 vaccine dose as she would likely need to have it at a higher level of care (hospital/dr office) and may need another type of vaccine (moderna vs J&J vs not get a second dose).
This spontaneous report was received from a nurse refers to a 52 year old female patient with drug reaction/ allergic to codeine. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength and dose were not reported). subcutaneous in the left arm. Concomitant therapies included LIPITOR, COLACE and loratadine (manufacturer unknown). On 11-DEC-2014, the patient experienced hard lump and redness that was 2-3 inches at the injection site and her arm was warm to the touch. The nurse reported by 14-DEC-2014, the reaction had completely resolved. On 16-DEC-2014, the redness reappeared. The nurse reported redness was back it spans 6 inches by 2 inches and spreads every day. Also reported, that her arm was hot to the touch now approximately on 19-DEC-2014. No Product Quality Complaint (PQC) was involved. Treatment was not taken by the patient. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Expired Pfizer COVID-19 vaccine (gray cap) booster dose administered to patient.
HORRIBLE PAIN; WEAKNESS IN ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced horrible pain, and weakness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible pain and weakness in arm was not reported. This report was non-serious.
We gave the Pfizer bivalent for 12 years and over for her who is 11 years old turning 12 in a month. no adverse reactions.
pt recv vax 9OCT96 & 11OCT came into nurses office c/o sever pain;rt deltoid 3" x 1 1/2" swelling redness-taking Ibuprofen 4hr;made comfortable-ice pack;
Became red and itchy all over started about 30 minutes after injection and became worse at about an hour then, was given 25mg Benadryl and symptoms subsided about 30 minutes after receiving Benadryl.
Initial report received from a consumer on 05 October 2012. A 42-year-old female patient, who had no known allergies and whose concomitant medications included 'Loestran' and MVI, had received a dose of the FLUZONE vaccine (batch number: unknown) in the right arm intradermally on 3 October 2012. The patient has received many doses of FLUZONE ID in the past. On 3 October 2012, same day of vaccination, the patient experienced 3 inches redness around the injection site that was warm to touch. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 17 December 2012. The patient had received dose one of FLUZONE Intradermal on an unspecified date in 2011. The patient had received dose 2 of FLUZONE Intradermal (lot number: UT4474AA).
the child has some muscle pain a the injection site; Pharmacist advised FLUBLOK was given to an 14 year old in error yesterday; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist The Agency (Reference number- 00327983) transmitted to Sanofi on 21-Oct-2020.  This case involved a 14 year old female patient who received pharmacist advised INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age) and for whom reported that the child has some muscle pain a the injection site (Vaccination site pain).  Medical history, medical treatment, vaccination details and family history were not provided.  Concomitant medication included sodium (NA).  On 20-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ509AA, expiry date: 10-May-2021) via intramuscular route in the left arm for prophylactic vaccination (Product administered to patient of inappropriate age as the patient was 14 year old).  On 22-Oct-2020, the patient developed a non-serious some muscle pain at the injection site (Vaccination site pain), 2 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was a case of actual medication error due to product administered to patient of inappropriate age (latency on same day).  Final diagnosis was Not Applicable pharmacist advised flublok was given to an 14 year old in error yesterday and the child has some muscle pain a the injection site.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event, vaccination site pain.  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.
Medication error. Patient was vaccinated under the age of 18 years old with Moderna. Multiple registration steps were missed during the medication error. The patient walked past registration, was not found in the system, and nurse proceeded with vaccination. Once error was identified patient was noted that vaccination was received outside the current EUA. Her guardian (father) and the patient were notified of the error received the EUA, recommended to enroll in V-Safe, and report any noted ADRs.
got sick a couple of times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick a couple of times".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extra as lot of pain to area and side of upper (left) body. Sore outbreak on neck had related pain to area of shot. Treatment extra rest next week and month, sores lower down of left side disappeared.
sore arm subsequent to vaccine; about 12 hours later chills began with no fever, fever developed around 14 hours after ad did vomiting and hypertension (160/100); tylenol relieved symptoms. Headache upon waking about 24 hours after but no fever. Nausea/heartburn continued for next 12 hours but relieved by antacid.