chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Third dose: her arm is red and she can barely lift it up and its swollen; Third dose: her arm is red and she can barely lift it up and its swollen; Third dose: her arm is red and she can barely lift it up and its swollen; her arm and it was hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 12:30 (Lot number: FJ6369) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Borderline diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 2), administration date: 17May2021, when the patient was 59 years old, for COVID-19 Immunization, reaction(s): "arm was red", "arm was red and swollen", "arm was red and swollen really big at that spot"; Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), LIMB DISCOMFORT (non-serious) all with onset 24Jan2022, outcome "not recovered" and all described as "Third dose: her arm is red and she can barely lift it up and its swollen"; FEELING HOT (non-serious) with onset 24Jan2022, outcome "unknown", described as "her arm and it was hot". Therapeutic measures were taken as a result of erythema, feeling hot.  Additional information: Patient had this same thing with the second dose where her arm was red and swollen really big at that spot from unspecified to unspecified date. The caller had her booster yesterday and her arm is red and she can barely lift it up and its swollen. The nurse said to ice it and raise it. The caller clarifies that she received the Pfizer covid vaccine third dose. The caller did-n't have a reaction with the first dose but had this same thing with the second dose where her arm was red and swollen really big at that spot. The caller got the third dose at 12:30 and when she woke up at 9:00 she could-n't hardly move her arm and it was hot and all red like a fever may have been in it. The caller tried to move her arm and got some ice and slept in her recliner until this morning and the redness is going away but its still swollen.  No follow-up attempts are possible. No further information is expected.
Pt vax w/ MMR; 2-3 days after vax devel generalized giant urticaria. Tx included Benadryl.  Sx resolved w/in 2 days.
Extremely high blood pressure (200 Systolic); repetitive severe nosebleeds, resulting in a need for surgery (coil X 2 and particle embolization of right internal maxillary artery.
presented to the ED for decreased appetite, lethargy and altered  mental status. History was initially obtained from the wife as patient was  completely non-verbal and unable to participate. At baseline wife states that  patient is a very functional adult (all ADLs) would walk out to get the mail  every day and make coffee but over the course of the past 2-3 days became  severely lethargic spending all day in bed, having a hardtime walking, confusion  to the point of minimally speaking, and only taking in minimal PO. Admitted with  acute encephalopathy, admitted to MICU originally for  hypercapnia and AMS. Pulmonary has been consulted for evaluation and management  of possible pulmonary hypertension. In the MICU he was found to be in aflutter,  underwent TEE with DCCV, treated for COPD exacerbation, stable for floor  transfer 5/7. During his stay work up notable for severely dilated RA and RV  with normal LV/LA size and no signs of diastolic dysfunction. RVSP was estimated  to 55 mmHg above mean RA pressure. CTA chest had a 1.4x1.2 spiculated lung  nodules in the RUL, 1.7 cm R hilar LAD, small 0.5 cm left apical nodule. Work up  thus far also with RLE DVT. He has also had an acute liver injury that has  improved with diuresis. When I saw him this morning patient reports he does not  have significant dyspnea a rest before this. He denies any hemoptysis, however  has been having significant night sweats for some time.
pt recv vax & w/in 4 days devel an inj site rxn characterized by swelling, redness, warmth & itching;tx w/APAP;
Patient received moderna vaccine as 2nd dose and received pfizer as first dose. Patient was ok, experienced no side effects.
During my menstrual cycle I usually have no symptoms other than tender breasts. So these symptoms were very unusual. Leg pains, pain and pressure in pelvis, clitoral pain, pain around vaginal opening, stinging like acid during urination that sent a shock through my entire body, uncontrollable bladder, nausea, large blood clots, lower stomach pain, flank pain, hot/cold chills, if I touch my belly button the pain radiated to my vagina, ovaries hurt, cervix pain, dryness, unable to get comfortable, crawling out of my skin, and constant urge to urinate, depression.  I landed myself in the ER where they told me to take Tylenol and Motrin and sent me on my way. These medications were not able to control the amount of pain I was in. I have now reached out to a couple specialists.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021 at 12:29 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-405642 (Patient Link).
I am still not feeling normal; low grade fever; Chills; Muscle ache; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 47-year-old (age at vaccination 45 years) male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate, colecalciferol (VITAMIN D). The patient experienced low grade fever, chills, muscle ache, fatigue (non-serious) on 29Mar2021. On an unspecified date, patient reported that i am still not feeling normal. The outcome of the events low grade fever and chills was recovered on unknown date. The outcome of the events muscle ache, fatigue and i am still not feeling normal was not recovered. The patient underwent lab tests and procedures which included two sars-cov-2 test: negative on unknown date. Therapeutic measures were taken as a result of low grade fever, chills, muscle ache, fatigue and i am still not feeling normal. It was reported that patient received 400mg of Ibuprofen and 1000mg of Tylenol as a treatment drugs.  Information on Lot/Batch number was available. Additional information has been requested.
She started to get sick immediately following the shot. I noticed she was drowsy and crying and rubbing her face all over. She then got congestion, cough, and fever. She didn't sleep that night, and wanted me to hold her all night long, she was very restless and loss of appetite. The very next morning she started to look in a dream state and didn't seem to see or respond to me. She then started to lose control of her head to the right side. Her head would drop to her right shoulder and her eyes would roll back in her head. She would also then sometimes drop her head back and roll her eyes. She also took her right hand and rubbed her right ear continually. I thought she was possibly so tired that she was doing these things from sleepiness. But they continued on and off for two weeks and then I knew it was serious and I was scared. I called the pediatrician and brought her immediately in. They saw her, sent me to see a Pediatric Neuroligist, and he sent us to another hospital for an EEG test to see if she was having seizures. All of the staff and doctors saw patient's seizure looking responses and they all saw her loss of muscel control to the right side.
On 4/22/21, 8 days after 2nd Moderna, pt. developed a pruritic, red rash on axillae bil. and trunk.  Denies headache or fever.  He called his doctor and received rx for a cream to treat the rash.   Rash got better and was mostly resolved by 4/30/21.
Woke up at about 1:00 AM with a 102 degree F fever, cold sweats, shaking very hard, headache, dizzy, and nauseous. It was hard to walk. Temperature and affects started going away slowly by about 9-10 AM and just the headache remained, by about 12 PM all side affects mostly went away. My temperature is now 98 degrees F at 4:15 PM.
About a week after my shot I have developed a red, itchy rash at the injection site.  Seems to be changing colors from red to white in the middle with a red outline.
Pt fully vaccinated for COVID with Pfizer. Unknown dates of vaccinations. Tested positive for COVID upon admission to hospital.
JOINT PAIN; SEVERE HEADACHE; FATIGUE; METALLIC TASTE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included suffered hemorrhagic stroke, and aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced metallic taste. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced severe headache. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on 13-MAR-2021, and joint pain, severe headache, and fatigue on 14-MAR-2021. This report was non-serious. The case is associated with Product Quality Complaint number # 90000173161 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.  Additional information was received from  Regulatory authorities on 17-MAR-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.
Initial unsolicited report received from a nurse on 01 September 2016. This case involves a 13-year-old female patient who was vaccinated with a first dose of MENACTRA (batch number, expiration date, dose not reported) intramuscularly and third dose of HUMAN PAPILLOMA VIRUS VACCINE (HPV) (batch number, expiration date, route, dose and site not reported) in the arm on 20 Aug 2012. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as Latex, erythromycin, zithromycin, sinular, bactrim, neomycin, cefuroxime. Illness at time of vaccination was reported as none. Concomitant medications were not reported. On 20 Aug 2012, same day (reported as began in first 24 hours) following the vaccination, the patient experienced exaggerated local reaction of the upper arm to the elbow with swelling and redness of the arm at the injection site. It was reported that, the patient required ER or doctor visit. Lab data was not reported. Corrective treatment received was Benadryl. The patient was not recovered from the events. List of documents held by sender: none.
Pt presented to clinic. Was given Pfizer vaccine booster dose d/t chronic health problems. Pt was 17 at time of booster and was 2 weeks early for the 6 month booster criteria.  Phone call to patient and grandmother. Only effects noted was sore arm at injection site. Advised to monitor for s/sx and report to family md and health department if she has any.
Swollen and sore injection site in the late afternoon (still sore on 7/2/2018),  fever, splitting headache, nausea - all in the early morning around 2am 7/1/2018.
Patient's mother reports excessive fussiness and irritability which started immediately after he received these immunizations as well as decreased appetite and redness/swelling at injection sites. These symptoms continued for a couple of weeks then subsided. At his next appt on 1/24/23 he appeared to have recovered fully.
Arm pain; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a week after receiving Shingrix and 2 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.   Additional details were reported as follows: The age at vaccination was not administered.  The patient over 50s year age group, coadministration with Shingrix and Flu vaccine. Shingrix arm pain. Two days later flu arm pain.
11:06 am Experience syncope episodes after receiving vaccine.  Vital signs BP 102/55, HR 65.  Sweaty and dizzy (afraid of needles). BP 127/75, HR 73, O2 sat 99 RA Accucheck 103. Client request to go home w/ spouse.  Cleared by EMT.
Pt recv vax on 9/1/98; on 9/2/98 pt exp swelling, itching, pain at vax site
Woke up with severe chest pain and chills, couldn't continue laying down had to go outside. Pain lowered to mild within 3 hours
patient received two flu shots for flu season 2022-2023. One in September 2022 and second on February 2023. She had forgotten about it. She reports no side effects or issues.
About 1 week after 1st dose started to receive chronic headaches and periods of dizziness to the point of falling over. Once every couple weeks. Muscle and joint soreness. Loss of strength. All of these ailments continue today's date. Has not seen a doctor yet.
Within 48 hours developed a case of acute urticaria (hives) on waistline and abdomen which continues to persist; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2022 at 13:00 (Lot number: FJ1614) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy to nuts" (unspecified if ongoing), notes: Known allergies: Tree nut allergy. Concomitant medication included: ADVIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7534; Anatomical site: Left arm; Administration time: 13:00), administration date: 20Mar2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8731; Anatomical site: Left arm; Administration time: 13:00), administration date: 10Apr2021, when the patient was 27 years old, for COVID-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset 28Jan2022 at 20:00, outcome "recovering", described as "Within 48 hours developed a case of acute urticaria (hives) on waistline and abdomen which continues to persist". The event "Within 48 hours developed a case of acute urticaria (hives) on waistline and abdomen which continues to persist" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient reported that he required a doctor's visit and prescription ointment. Treatment included steroid ointment and ZYRTEC. Since the vaccination, the patient had not been tested for COVID-19.
BRought in by son due to hyperglycemia. On 10th floor oncology/medical unit of a local hospital same day, staff were informed patent's other son has COVID. Patient tested positive and has been on 4.5 L O2
Received vaccine on 12/23/20 at approximately 7:35pm. By 10 pm the right arm started to swell at the injection site and became itchy burning and red. A knot the size of a gumball appeared. By the next morning it was the size of a softball.. It continued to spread to a rectangular shape a little bigger than a softball approximately 4" in height and 8" in width. Arm was sore and itching. I tried my best to keep from scratching at the site and took my claritin and ibuprofen and made sure to wear a long sleeve shirt to keep me from scratching at it. I figured I was making it worse because I tend to sleep on my right side as well. By Sunday night it went away.. Then Tuesday night the 29th of December arm started getting itchy and burning again. By Thursday the 31st my arm was back to the size of softball again and arm itchy and red. Let a few physicians hear in the emergency room where I work look at it and their only suggestion was to use a topical Benadryl. I never officially took my temperature but their was definite heat coming from the site. Not a single physician could explain why it went away and then came back. The knot didn't grown any bigger and with the topical benadryl I have managed to keep the itching away. The swelling started going back down again on Sunday 01/03/21 but there is still a knot the size of a grape now and the area is still red. Some days it is itches more than others.
Patient stated after the 2nd dose that she had the J and J vaccine in the past. She said she wanted to get this vaccine since she felt that the J and J did not work for her. She informed us after she got the 2 nd dose.
Redness, warmth, swelling about golf ball size to the injection site, headache, fatigue last 12-24hrs, recommended TYLENOL or MOTRIN as directed on box, BENADRYL also as directed on box.
hypotonic-hyporesponsive episode;pallor, lethargic-vomiting several times;
Fever and Headaches May 23rd, again on June 3rd and June 19. Fever continued until she was diagnosed with Aseptic Meningitis and hospitalized on 7/15 through 7/19. Consistent fever for months. Went back to ER 7/23 and then again admitted on 8/18 through 8/31. MRI, CT and Blood Work all negative. Treated symptoms with Prednisone. Pain in the right side of her head. Partial hearing loss still running low grade fever on 9/20. Follow-ip appointment with ENT on 9/21. Still no answers or relief.
Day 2/3  Headache (busting)  Muscle Pain  Hair hurt   NO Treatment Day 4/5/6 Alergy event  Runny nose, mild cough etc.  NO Treatment Day 9 Sore Throat partial loss of Voice.  NO Treatment Day 10/11/12  Mid Level Sore Throat, Muscle Pain, Congestion  Treatment Sudafed/Benadryl DAY 13 Ears ringing Popping/ major congetsion  NO Treatment DAY 14 July 31, 2021.  Major ear ringing, EAR Pain/ Congestion 6 of 10  NO Treatment
On Jan.26th the left axilla was tender and swelling was present, right in the middle of the axila.  On Jan.29th swelling, hot and tenderness present on both cheeks. The swelling is more pronounce on the right cheek than the left.
Red rash on face - per mom via telephone 6 hrs after administration.  Rash spread to arms & chest as of 5/9/08-no acute distress.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (lot # K020216, expiry date 17-SEP-2016; strength, dose, frequency, route of administration were not reported), which were exposed to temperature outside of the recommended range. There were no concomitant therapies reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Employee stated she felt numbness to arm of injection and warmth, symptoms are outside of common side effects listed on vaccine insert.
This spontaneous report was received from a nurse via a company representative and refers to a 12-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date, patient was vaccinated with a dose of GARDASIL 9 for prevention of human papilloma virus (HPV) (dose, route of administration, lot# and expiration date were not reported). On unknown date in June 2018, reported as with past month and on unspecified time after receiving the vaccine, the patient's blood pressure dropped, he became pale white for 15 minutes and then vomited. The patient did not receive any treatment for the events. The patient recovered from the events on an unknown date in 2018. The relatedness between the events and GARDASIL 9 was not reported.
This Native American/Alaskan female received 3 doses of Haemophilus b conjugate vax and subsequently developed meningitis and unspecified blood work and CSF analysis which were positive for  Haemophilus type b due to vax failure. These events were considered other medical events. Subsequently the pt "survived." Sixteen additional pts had similar experiences following exposure to Haemophilus b conjugate vax. Follow up information states: "Additional information has been received from a published abstract titled "Haemophilus influenzae invasive disease among children aged <5 years--epidemiology in the United States, 1994-1999" from the 34th National Immunization Conference on Vaccine Preventable Diseases (WAES # 00102472); abstract is attached."
No other AE's reported; temperature excursion/Varivax administered to a patient during a temperature excursion .; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.      On 15-FEB-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength and route of administration were not reported, lot # T021821, expiration date was 25-JUN-2022) 0.5 milliliter for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 7.4 degree Celsius for a time frame of 3 hours and 54 minutes, as recorded by the digital data logger. There were no previous temperature excursions. No further adverse event (AE) information was provided.  This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2102USA008793:
Patient was vaccinated and is under the age of 18. No complications from being vaccinated at this time.
The infant had a seizure consisting of rhythmic jerking of the arms and legs lasting approximately 30 seconds. The infant became pale during the seizure. After 30 seconds the infant had a far off gaze and then became very sleepy. The infant was brought to the doctors office and lab work drawn.
1/17/23-all of sudden i lost my hearing in left ear 2/3/23-primary doctor gave me Prednisone 20mg 3times daily/10 days 2/16/23-saw ENT. have lost of hearing in both ears (left ear 80%). Said i could live with it, get a shot in ear but don't really recommend or get a hearing aid.  I went with a hearing aid ($860.00)  Had Covid on 12/13/22. tested negative 10 days later
Angioedema (swelling of the lips) noted. Resolved within 2 hours of taking benadryl.