chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot flashes; body was hot all over; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient got vaccine and got hot flashes and body was hot all over that night and was fine the next day. The event outcome for events was recovered.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Patient vomited within 10 minutes of dose 1 with immediate recovery back to baseline. He was monitored for 20 minutes and discharged into the care of his family member who was driving his car.
Initial unsolicited report received from a non-healthcare professional on 14 September 2015. This case involves a female patient (age not reported) who was vaccinated with FLUZONE HD [batch number, dose, dose in series, route and site of administration were not reported] on an unknown date (two years ago). The patient had received high dose for first time. The patient's medical history and concomitant medications were not reported. On an unknown date, two hours following the vaccination, the patient had experienced atrial fibrillation and tachycardia. Laboratory data and corrective treatment were not reported. The outcome of the events was unknown. Upon medical review, the case was considered as serious due to important medical event: atrial fibrillation. List of documents held by sender: none.
Generalized not feeling well, "flu-like" symptoms evening of flu shot that persisted thru week; 10 days after flu shot feels "burning-rash-like" sensation across abdomen; no visible rash, took Benadryl X 2 doses, also unable to urinate, went to ED Foley catheter placed, 12 days post vaccination still unable to urinate, tingling/numbness in legs, loss of sensation/weakness; ascending paralysis; MD diagnosed Guillain Barre' syndrome; has had nerve conduction studies, the last ones very consistent with Guillain-Barre'; completed 5 days of IV IG.  He has also been on Solu-Medrol, pt has required mechanical ventilation, plasmapheresis, currently remains in ICU with quadraplegia. 4/28/08-records received for DOS 3/4-4/16/08-DC DX: Myeloradiculitis secondary to flu vaccine. Status post tracheostomy. Status post percutaneous gastrotomy. Several weeks following flu vaccine developed urinary retention followed by ascending motor and sensory dysfunction consistent with Landry Guillain Barre syndrome. Ventilator dependent for short period off during day but at night goes back on ventilator for support. Several apneic episodes. Treated with IVIG and plasmapheresis. Prior to third run of plasmapheresis suffered a respiratory arrest due to mucous plugging. Developed pneumonia and became septic. At time of discharge able to sit up with assistance, failed swallowing evaluation. Tube feeding.  1/20/2010 Patient expired several months ago.
I asked the guest if she has any history of fainting with shots and she said NO but then her boyfriend laughed and she said "you're never going to let me forget that". I asked again if she was ok to get the shot and she said yes. So I proceeded to give her the shot and she fainted soon after the shot was given. Pt fell to the ground and back. Her eyes shut for a few seconds. Her boyfriend and I sat her up as soon as I saw she was breathing and ok. Her boyfriend then told me that she fainted when she gave blood. I fanned her for a little bit and gave her water. She said she felt fine but a few mins. later she said she didn't feel so great so I called 911. They examined her and she was fine but still asked if she wanted to come to the hospital and she refused. She remained here for another 10 minutes and I asked again if she felt ok and she was fine so her boyfriend took her home.
Pseudoaneurysm of femoral artery following procedure. Hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Administration of Moderna COVID19 vaccine to a minor (16 year old) at the request of patient's guardian (mother). Patient is 160 pounds. No clinical adverse event to date.
significant torso hives involving upper arms, trunk, neck, and groin. Occurred 6/26, treated with claritin. Recurred 6/28, treated with zyrtec
Patient developed a fever to 102.9 and had repeated eye twitching/possible seizure activity within 24 hours of vaccination.
This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to a patient of unknown age and gender. On 04-SEP-2015, the patient was vaccinated with an expired and improperly stored dose of PNEUMOVAX 23 lot # K004542, expiration date: 19-AUG-2015 (dose and route were not reported). No adverse effect reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of three reports received from the same reporter. Additional information has been requested.
Swelling and pain in my upper left arm the next day after the first shot received. Also some redness, and itching.  Today is 8 days later and there?s still a small lump under the skin, with itching.
By 4:30 pm had 102.7 chills, body aches headache, uncontroable shakes.  Im a nurse practitioner thought it was immune response to vaccine. It was better by morning. After that felt fatigue and weak. Planne for second vaccine on 2/10/21  had vaccine and had same repsonse but at 2:30 am and s/s were gone by morning but was off stayed home to rest. Had Covid disease in November 2019 sever Headache could not move eyeballs with increasing pain in head,  body aches and chills nausea and stomach  cramps. Had positive PCR antibody test for Covid. In this year of 2021 have increasing fatigue and brain fog, body aches unable to work had to take early semi retirement 07/21.
The patient complained of left arm numbness, especially in the left hand, "jumping muscles" in the left upper arm, more effort required to use fingers, loss of dexterity, and hand strength.
Approximately 31 hours after receiving the dose, it was about 11;30 PM on 9/8/22 I woke up with a bad headache which started at the back base of my left side of my head and went up and around my left eye. Even today  9/9/22 11:21 AM I still feel like I have a slight headache across my forehead. When it first occurred I got up and took Acetaminophen extra strength two tablets and was able to go back to be and slept through the night. I have not taken anything for the headache this morning. I have had my normal prescriptions. The headache across my forehead is not at strong as the one I felt last night.
Unusual rash on right breast - looked like 8 clustered insect bites, another large red bump at armpit, and another near nipple.  Initially felt like burn or abrasion.  Then developed a soft lump under armpit.  Rash became very sensitive and when pressure applied felt like bruise.  The day after symptoms began, severe pain was experienced- throbbing, stabbing, and extreme sensitivity.  It was necessary to take hydrocodene for pain for the first 4-5 days.  Rash occurred at the sight of a benign lumpectomy in 2017 so I was very fearful it was signs of breast cancer. April 15 I had a mammogram and ultrasound at Imaging Center.  No signs of cancer were indicated and lymph node under are was inflamed.  I was advised several of their patients underwent biopsies under their arms for this same condition before they determined the link with the COVID Vaccine.  The rash seemed to be similar to the description of ?COVID arm.
Injection site is red, swollen; injection site swollen; Itching; Warm to touch; A spontaneous report was received from a pharmacist concerning a thirty-eight year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced injection site is red, swollen, itching, and warm to touch.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (LOT number 025J20A) on 27 Dec 2020 intramuscularly in the left arm deltoid muscle for prophylaxis of COVID-19 infection.   Patient received the vaccine 27 Dec 2020 and stated everything seemed fine but during the weekend on 03Jan2021 the patient noticed that the injection site was red, swollen (described a 3 inch radius like a hamburger patty), itching and warm to touch.   Treatment for the events included hydrocortisone (03 Jan 2020 and 04 Jan 2020), diphenhydramine, ibuprofen and acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The event outcomes for injection site is red, swollen, itching, and warm to touch are considered unknown.; Reporter's Comments: This case concerns a 38 year old female patient who experienced the non-serious expected events of  Injection site redness and Injection site swelling, and non-serious unexpected events of pruritis and feeling of warmth. The events occurred 8 days after the first dose of mRNA-1273. Very limited information regarding these events has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever of 100.5; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever of 100.5) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical history was reported by the reporter.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced NAUSEA (Nausea). On 03-Apr-2021, the patient experienced PYREXIA (Fever of 100.5) and CHILLS (Chills). On 03-Apr-2021, PYREXIA (Fever of 100.5) and CHILLS (Chills) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within 20 minutes of receiving the vaccine, he developed red, hot cheeks, with red splotches around mouth and neck. Low-grade fever.
Patient came in and showed me her red swollen arm. She said it was hot to touch and she was very concerned. It was red splotchy and looked obviously swollen. It did appear to be in her deltoid muscle.
Elevated BP 200/120 known history of hypertension. Headache, Nausea and headache
Hives, no fever, no itching.  Gave Motrin and a bath.
Woke suddenly, 90 minutes after eating, vomited an excessive amount, fussed for 20 minutes, went back to sleep without eating. Did not offer food for fear stomach was still up. Sleeping 30 minutes now.
Vaccine was improperly administered into shoulder joint rather than deltoid muscle below the joint.  Sharp shooting pains at the time of vaccine continuing to this hour. Severe pain and inflammation. Unable to move arm in shoulder joint.  Radiating pain across left back and neck, arm, and hands.
5 days after receiving vaccination on 09/20/21, the patient states he developed symptoms which included  chest pain, palpitations, shortness of breath, throat congestion, fatigue, left mid back to left anterior rib pain, and a rarely productive cough.  the patient was first seen in office on 10/29/2021, the patient states symptoms  are still persisting.  The treatment plan included, lab work, referral for ct of the chest, referral to cardiology, ekg , nebulizer treatment, and spirometry.  the patient was administered kenolog 40 mg in office, and prescribed oral medrol dose pack to start the next am.  the patient  also prescribed montelukast.  the patient will be reevaluated in 1 week.   *please note, pt reported that his son tested positive for covid 19 on 10/01/2021.  the patient states he got tested for covid 19 on 10/02/2021 via pcr, pt states results were negative for covid 19.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-FEB-2008, the patient was inoculated with ZOSTAVAX at a medical center for routine health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at the same medical center for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient 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. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Started to feel odd the evening of the vaccination. Tingles and nerves felt like it was going berserk.  Called doctor about it and was advised to come in for exam.  Waited a few days and the tingles did not go away. At the time of the exam my lower arm was swollen and numb. After a physical I was referred to a neurologist. EMG study done at that time. Small nerve neuropathy was discovered. No treatment given but a sling to help sleep. Asked to return for follow-up every 6 months to monitor progress.
Big red splotch, covering half of the upper left arm.  The area is hot and itchy as well.
Pt. developed hives 1 hour after vaccines given - located on lower left arm / jawline (not at the site of injections). Did not give BENADRYL - resolved within 2 hours.
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported for 71-year-old female patient that received PREVNAR 13 at single dose for immunization duloxetine HCL, LYRICA, PLAVIX, TYLENOL, diazepam, hydrochlorothiazide and codeine sulfate, route of administration, dose date and indication were not reported. Relevant medical history and concomitant medication were not specified. On unknown date the patient experienced an allergic reaction. Pfizer is Marketing Authorization Holder of diazepam in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of diazepam has submitted the same report to the regulatory authorities.
12/31/2020 vaccination 1/8-1/9 itching in face and swelling under L armpit, lymph nodes. Itching was from my earlobes, bottom lip, bottom chin and back of head. Visible rash on face. Symptoms lasted 2-3 days.  PCM -  prescribed steroids. Took care of the symptoms.
Report describes erectile dysfunction in a 41 year old male who received hep A vaccine. The pt was allergic to PCN. He reportedly had no pre-existing medical conditions and was taking no concomitant medications. On 04/25/2001, the vaccinee received his first doses of Havrix, and Hep B. The vaccinating physician reported that the pt experienced chills and did not feel well in the evening of 04/25/2001. Three days post immunization, on 04/28/2001, the pt reported general achiness, numbness, and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed Medrol Dosepak. On 05/16/2001, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, a rash, and a small perioral ulcer. Viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C reactive protein were performed. The physician prescribed acyclovir and referred the pt to an infectious disease specialist.  On 05/16/2001, the pt's father reported that his son developed a generalized red raised rash; itching; flushed face, nausea, fever and mouth blisters within four hours of immunization on 04/25/2001. Several days later, the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and possible nerve damage. The urologist reportedly prescribed Levaquin. On 05/18/2001, the pt's father reported that his son's condition has worsened. He stated that his son had sexual dysfunction due to numbness in his penis. He also reported that the pts facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt now will suffer with a loss of income, too. On 05/18/2001, the pt stated," I am having a reaction to one or both of your vaccines. I am having erectile dysfunction." No other symptoms were reported. On 05/18/2001, the infectious disease specialist stated that the pt reported tingling of the face, vague malaise, a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 05/18/2001, all adverse events were unresolved and the pt's condition had worsened, per the pt's father. On 05/31/2001, the internist found the condition of the pt to be normal except for the subjective complaint of erectile impotence. The physician recommended prednisone as treatment. The pt was previously seen by a urologist who prescribed Medrol DosePak, the pt subsequently felt better for awhile. When he stopped taking Medro DosePak his symptoms returned.
Information has been received from a physician concerning a 2 month old male, with an unremarkable medical history and no allergies, who was vaccinated with a first 2ml oral dose of Rotateq vaccine (human-bovine). Subsequently the patient experienced diarrhea. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Initial misuse report received from health care professional on 29 Oct 2013. It was reported that pediatric patient had received second dose of FLUZONE at 20 days instead of 30 on an unspecified date. No adverse event was reported. List of documents held by sender: none.
3x3cm left upper arm warmth, redness, raised, slightly indurated, blanching, not tender.
After being vaccinated I suffered from chills and twitching which I was told would subside. After a couple days the symptoms did subside, however on 1/30/2022 I suffered my first seizure.  Since then I have been having minor seizure activity.  On 4/30/2022 I was diagnosed with covid 19 after again suffering from chills and high fever. Subsequently my seizure activity has stopped while suffering from COVID. The vaccine caused me to have seizures.
Stiffness, tenderness, loss of strength, weakness. Treatment was ultrasound and ibuprofen.
Day 1: Fever, chills, body aches within 12 hours. Day 3- until current Day 7 extreme abdominal pain. Pain when moving, staying still. Pain will not go away
Low grade fever; body chills; body aches; headache; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 03Apr2021 at 11:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 21:00, the patient experienced low grade fever, body chills, body aches and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events low grade fever, body chills, body aches and headache were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
She woke up with urticaria on legs, chest, and face.  Also fever to 101.
Increasing pain, swelling, induration, warm to touch.  4 cm x 6 cm firm area showing cellulitis.  Treatment Cefril.
3 bumps that looked like blisters about an inch away from vaccination site; Spontaneous report received on 20Apr2019 from a consumer via a medical inquiry.  A 24 year old male reported that he experienced injection site pain, injection site discharge and blisters following immunization with ACAM2000 (smallpox vaccine).  About 10 days ago, he stated that after receiving the vaccine, the area was sensitive. The male reported that he eventually developed some pus and drainage at the site but that he did not develop a hard scab.  He also stated that the vaccination site was not healed and that when he changed his bandage, he noticed 3 bumps that looked like blisters about an inch away from the vaccination site. The patient questioned as to what he should do about the blisters and was informed to contact his doctor for more information. The outcome at the time of report was ongoing.  The patient's medical history included that he received the BioThrax (anthrax vaccine adsorbed) vaccination 1 month prior to the ACAM2000 vaccination, but no other vaccines the day he received ACAM2000.  Allergies included a penicillin allergy.  Concomitant medications included Valtrex 1g.
Information has been received from a medical assistant concerning a 41 year old female with high cholesterol and hypertension who on 10-SEP-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 mL first dose of Pneumovax 23 (Lot # 658673/0990U). Concomitant therapy included atorvastatin calcium (LIPITOR), stanolone (PROTONA), metoprolol, mometasone furoate (NASONEX) and amlodipine besylate (NORVASC). Within 24 hours post-vaccination, the patient developed tachycardia, increased blood pressure, hot, red, swollen right arm, with swelling from injection site down to elbow and fever of 104 F. The patient was hospitalized on an unspecified date for 2 days. Blood work was performed and the patient had an increased white blood cell count. An echocardiogram was also performed (results unknown). On an unspecified date, the patient was released from the hospital and at a follow-up visit was feeling better ("improving"). No product quality complaint was involved. Additional information has been requested.
Mild febrile seizure 7 days after shots Hosp overnight  - NA low - Had been out in heat when seizure occurred 13 mo old and first set of shots.