chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in axillary and breast; swelling in axillary and breast; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Aug2021 as dose 2, single (Lot number: FC3181) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: T3/T4 SUPPORT; VITAMIN C [ASCORBIC ACID]; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Demerol, reaction(s): "known allergies: demerol"; Sudafed, reaction(s): "known allergies: sudafed"; Augmenting, reaction(s): "known allergies: augmenting". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FA7484, Location of injection: Arm Right), administration date: 29Jul2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious), BREAST SWELLING (non-serious), outcome "unknown" and all described as "swelling in axillary and breast". The events "swelling in axillary and breast" required physician office visit. Therapeutic measures were not taken as a result of swelling, breast swelling. Additional information: Other medical history - factor 5 (as reported). Unknown if patient experienced COVID-19 prior vaccination and was not tested for COVID-19 post vaccination.
no additional adverse events; patient was given a dose of VAXNEUVANCE after the dose was stored improperly; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAY-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #w027275, expiration date: 09-JUL-2024, administered as prophylaxis (strength, and route of administration were not provided), after the dose was stored improperly on 02-MAY-2023 at a temperature of 34 Fahrenheit degrees for 7 hours (Product storage error). No additional adverse events nor previous temperature excursions were reported.
Initial report received on 31 October 2008 from a healthcare professional. A 12 year old male patient, with no medial history, no concomitant medication, and no illness at the time of vaccination, received on th afternoon of 30 October 2008, a left deltoid intramuscular injection of MENACTRA and a right deltoid intramuscular injection of ADACEL. On the evening of vaccination, the patient developed fever. The following day, lightheadedness, dizziness, and vomiting. His blood pressure was within normal limits. No other symptoms were reported. At the time of the report, the patient had not recovered. Follow-up information received on 19 November 2008 from a health care professional. Per the reporter, the patient started having fever that night after receving the ADACEL and MENACTRA vaccines. The fever was over 104.0 degrees Fahrenheit and the patient was told to come into the office the following morning. When the patient arrived to the office the next morning, his temperature was taken and his fever was 101.5 degrees Fahrenheit, and all of his vital signs were fine. The patient was treated with a dos eof MOTRIN while in the office. Per the reporter, the patient did have some vomiting and headaches. The recovery statis of the patient was not reported. Follow-up information received on 06 December 2008 from a health care professional. It was reported the patient recovered; however, a recovery date was not provided. No further information is expected. Documents held by sender: None.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 04-NOV-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T036820, expiration date not reported, but upon internal validation established as 01-JUL-2022, 1 dose, route was not reported) for prophylaxis (product storage error).  The  temperature excursion occurred on 01-NOV-2021. The temperature during the excursion reached 5 l .2 Fahrenheit(F) and the product was out of range for 35 minutes. No prior excursions. No other adverse event. The reporter confirmed that no other products were administered after the temperature excursion.
Left deltoid 6x6cm cellulitis. Admitted 6/9/05-6/11/05. Information from discharge summary states swelling, inflamation of injection site, fever. msv
covid vaccine reaction. Recieved Jansen COVAX Yesterday now with HA, Bodyaches, sore throat, tired, sluggish, rigors and chills, requesting quarters. 32 yo M w/ no known chronic medical conditions, presents w/ FLS that started shortly after receiving J&J vaccine, as above.   VS w/o acute abn. Well-appearing, NAD.
Respiratory failure - ventilation.  IVIG 30gm daily x5 days.  This is a 43 year-old male who as in his usual state of good health until three days prior to admission when he noted some low back pain and tingling in his legs.  He also noted complaints of sinus congestion and drainage.  He saw Dr. in the office on 6-25, and was given AUGMENTIN for sinusitis.  He mentioned his numbness in his legs and it was decided to see how he did after his infection had cleared and then work that up as necessary.  He also went to a chiropractor who adjusted his back and he had improvement in his low back pain.  However, he had persistent numbness in his legs and in his arms he described as feeling as if they had gone to sleep and were tingling.  He got to the point today where he had difficulty ambulating and even fell in his garage and has a small cut on his right ear from that fall.  He presented to the emergency room and was noted to have significant difficulties with ataxia and was thus admitted for further evaluation and care.  He does not that he has had multiple tick bites since he lives on a farm, but has not noted any significant skin rashes.  He also has not urinated all day, although he has not taken in very much fluid either.  In the emergency room his white count was 11,900, hemoglobin 16.2.  Electrolytes were unremarkable and BUN and creatinine were 14 and 0.85 respectively.  His liver enzymes were unremarkable.  A tick panel was sent off for evaluation. 7/21/08-CDC's CISA staff has reviewed VAERS # 318176 and confirmed that this is GBS level 1. 9/12/08 Received hospital D/C/ summary for 6/27-7/23/2008. FINAL DX: Guillain Barre syndrome; pneumonia; respiratory failure; & elevated liver enzymes. Report states patient initially admitted w/difficulty walking then quickly developed UE extremity weakness & trouble breathing.  Consults by neuro, ID & GI done.  Mechanical ventilation, IVIG, enteral nutrition, antibiotics & was extubated when pneumonia improved.
low grade fever; tiredness; pain around injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified dates, the patient experienced low grade fever, tiredness, and pain around injection site. The events were reported as non-serious and did not require hospitalization. The events were treated with ibuprofen. The clinical outcomes of low-grade fever, tiredness, and pain around injection site were recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.
Information has been received from two physicians concerning a 64 year old female with a history of adverse drug reaction to TAGAMET (dizziness) and (ZANTAC)(dizziness), estrogen intolerance, and (PRILOSEC)(diarrhea) and hives when she was a child, who on 11-JUN-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (LOT # 659406/0298X) 0.5 ml subcutaneously for the prevention of shingles. Concomitant therapy included multivitamins, (CANTRATE) and (ACIPHEX). The initial physician reported that on 11-JUN-2008, the patient experienced an itchy rash with hives at the zoster vaccine live injection site. The second physician reported that on 16-JUN-2008 the patient experienced hives on her legs, arms and back. At the time of the report the patient was recovering from itchy rash with hives at the zoster vaccine live injection site. The outcome of hives in her arms, legs and back is unknown. No additional information is expected.
Local reaction to Influenza vaccine. One round, warm, indurated, blotchy, erythematous, lesion (about 5cm x 5cm) on outer (R) thigh. No tenderness to palpation. No red streaks. Pt on BACTRIM R/o cellulitis.
I had my first COVID shot in April./Would I still be able to get the second dose now?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had my first COVID shot in April./Would I still be able to get the second dose now?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had my first COVID shot in April./Would I still be able to get the second dose now?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had my first COVID shot in April./Would I still be able to get the second dose now?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment drug information was provided.
Pt state she went to ER after shots because right arm was red and her upper lip became swollen she said the next day her bottom lip was swollen.  ER told her to take Benadryl and sent her home.  She said the ER DR thought it was from the MMR vaccine.  Pt stated no tongue swelling and no shortness of breath or other symptoms.
Bright red circle, 2? by 2.5?.  Warm to touch. Large lump under skin. Itchy.  All lasted roughly 2 days before got better.  Used Benadryl cooling gel to soothe.
i couldnt sleep, woke up many times with chills and a really bad headache, the whole day ive been sick to my stomach and my head hurt. i even threw up a lot
Within ten minutes of receiving the injection my skin became slightly red on my left arm near the injection and on the left side of my lower left  neck  near the clavicle.  My heart rate increased to 98 bpm. My resting  heart rate is in the upper 60s to low 70s.
Inconsolable/prolonged crying - 7 hours. Severe allergic reaction? Possible rapid heartbeat/difficulty breathing? (3 years later she tested positive to a severe allergy for Baker's yeast, which the vaccine is cultured in and many other foods.)
Admitted to hospital with extreme fatigue and difficulty breathing on 11/14/2021.  Diagnosed with COVID pneumonia and discharged 11/24/2021, to ECF for further rehab.  Discharging to home 12/10/21.    Onset of illness was 11/2/21 SARS-CoV-2 Antigen positive 11/4/21
1030PM 19OCT94 12 hrs p/vax pt found white, floppy in bed-cried & pinked immed when in dads arms-afeb-was fine-called 20 mins p/event to report it to have it noted in chart;
I was very sick (felt like the worse flu I ever had for 36-48 hrs) for each shot and booster. The last booster was the worst and symptoms lasted the longest. Headache, chills, body aches & pain, nausea, severe fatigue. Within a 5 week window of my last booster, my hairdresser noticed a circular spot on the back on my head where hair was missing. I also noticed a significant amount of hair loss when washing/brushing my hair and my scalp was very itchy for months. Then 2 subsequent eraser size hair loss spots were located on the right side of my head. After about 3-4 months the hair loss stopped and again appeared normal . The hair has not grown back. I  have since had 3 steroid shots in the spot on the top back of my head. I also used Fluocinonide for the itchiness.
This spontaneous report as received from a physician via a company representative refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 (lot, dose, route of administration not reported) as either second or third doses after previously receiving GARDASIL (lot, dose, route of administration not reported) as a first dose. No adverse symptoms were reported. The relatedness between the adverse event and suspect therapies was not reported. Additional information has been requested.
Patient reports breaking out in hives approximately 13-14 hours post flu shot. No airway involvement.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: ER8735) at the age of 36 years as dose 2, single and administered in arm left, administration date 11Jun2021 10:00 (Lot number: ER8735) as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "Shortness of breath"; HYPOAESTHESIA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "numbness in arm & hands"; NAUSEA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "shivers without fever"; PALPITATIONS (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "heart palpitations"; GAIT INABILITY (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "unable to walk"; FATIGUE (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "weakness"; ARTHROPOD BITE (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "ticks around arm"; CONTUSION (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "sensation of bruised under rib cages"; MOVEMENT DISORDER (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "left arm unable to move". Therapeutic measures were not taken as a result of dyspnoea, hypoaesthesia, nausea, chills, palpitations, gait inability, fatigue, asthenia, arthropod bite, contusion, movement disorder. Additional information: The patient did not receive any other vaccine in four weeks of suspect vaccine. No medications were received within two weeks of receiving Covid-19 vaccine. No known allergies. The patient was neither diagnosed with Covid-19 prior vaccination, nor been tested for Covid-19 post vaccination. No follow-up attempts are possible. No further information is expected.
Patient experienced swollen arm, hot to the touch, painful, rash around injection site, she called her doctor who informed her to apply ice and call in the morning if not better.
My name is patient, 71 year old. On 5/5/21 my Cardiologist told me to go to the ER to get a Chest CT. I was diagnosed with PE (Pulmonary Embolism). I was put in ICU under blood thinner Heparin drip treatment. On 5/09/21, I was discharged to go home to continue treatment with blood thinner Eliquis.  I have always been an active healthy person with no major issues other than one Stent put in my Left Descending Artery by doctor in June of 2013. I've been playing Tennis (mostly singles) on weekends till last November and I've been playing Ping Pong on weekdays till end of April. Never expected to getting this PE. Could this blood clots be the result of Pfizer Covid Vaccine ?
Tues. April 6 about  8 p.m.  felt cold and feet began to itch I put lotion on them to keep them               from itching. Wed. April 7 4:45 a.m.  noticed a light red rash on feet, lower legs and knees ? applied lotion to                 keep from itching.              Low grade fever ? 98.6 (not normal for me I normally run 97.4)              3:00 p.m. rash had moved up legs, buttocks and onto stomach              3:45 p.m. in bed shaking with chills for a time (45 minutes?) and temp about 100.4              7:30 p.m. fever up to 102.4 and ran a fever all night              *Took Benadryl for rash itching and Aleve for fever Wed. April 8 11:00 a.m. noticed rash was on back of arms and front hairline low grade fever all               day              4:30 p.m. chills again with shaking for about 30 minutes and fever of 102.2              *Took Benadryl for rash itching and Aleve for fever Thurs. April 9 rash began to turn a dark purple color, feet ankles and hands swollen, ran a low              grade fever              ** Husband took me to Clinic and I saw Dr. ? Prescribed ? MethyiPERDNISoline tablets 6 day dose from 6 tablets first day decreasing 1 tablet each day until gone. ? Triamcinalone 0.01% to put on rash ? Allegra  180 mg take one each morning ? Benedryl take 1 each night ? Pepcid take 1 each night By the time we got back to pharmacy to fill the prescription (about 5:00 p.m. I again had chills (about 30 minutes) and fever spiked to 102.6 Took Benedryl and Aleve at bedtime Wed. April 14 ? feet looked like I had Portwine stains (birthmarks) on them and feet and hands              still swollen Fri. April 16 ? husband had an appointment with our regular Dr. at the Clinic.  We mentioned my rash and talked to him about having my 2nd dose.  He               said, ?Absolutely NOT! Not with this type of a reaction to the first one!?   He had me              stay on the Allegra and Pepcid but he also put me on  *HydrOXYzine Hydrocholride 50               mg tablets every 6 hrs.  I have not been able to take them every six hrs because they              ?knock me out? and I have other responsibilities.  I do take 50 mg about 9 p.m. and               3 a.m. daily. Sat. April 17 ? low grade fever all day but fever didn?t spike and I didn?t  have chills Fri. April 23-  17 days later?I still have a rash though it is slowly going away.  The rash on my                stomach is very light.  I no longer look like I have Portwine stains on my feet and the               swelling is gone.  I am still taking Allegra and Pepcid daily with the 2 doses of                HydrOXYzine 50 mg at night.  I am not using the lotion because Dr. said to                use it 14 days then off for 14 days and then on for 14 days.  It took us a little while to figure out what was wrong and then by husband decided to have it documented and to see if it was safe for me to have my second vaccine.  ***I have pictures to substantiate what my reaction looked like and the dates and times.
Patient experienced 1 episode of vomiting 10 minutes after vaccination. Patient was experiencing a migraine HA prior to vaccination, suspect that to be the reason for his vomiting.
A second influenza vaccine was administered to patient, due to, slowed documentation of the first vaccine.
Became extremely exhausted by the evening with slight back pain. At about midnight, woke up with fever of 102, severe back pain, and cold sweats. Did not sleep through the night. Woke up with vomiting, severe body aches, cold sweats, shivering, continued fever of 102. Took 2 tylenol every 6 hours and fever did not drop below 100 at any time. Had severe body aches mostly in the back. Slept for a few hours at a time the day after the vaccine. Constant shivers, sweating, vomiting body aches. Took Tylenol before bed, woke up the next feeling. Second day to present some brain fog, but not other side effects continued on.
After having Covid for 10 days in January.  I got the vaccine at the of April and second shot mid May.   No real issues except the normal side effects.  Headache, pain at injection site, fever in injection arm only, joint pain in injection arm, some diarrhea, and some aches.       Starting in June, I started to notice things smelling differently.  Mold was more pungent, perfumes  a bit more musky, onions like they were a bit older.   My mucus in my nose is much much thicker now and my mouth saliva produces lots more than it did.  My taste is now very metal like and sour.  Food now taste different.  It seems like it?s getting worse as time gets farther away from the vaccine time.
Patient is a 19yo male who experienced a near syncopal episode immediately after receiving his first dose of Pfzier covid 19 vaccine. Patient c/o dizziness and tinnitus, patient then noted altered level of conciousness, w/o complete loss of consciousness. Upon assessment patient noted with significant diaphoresis, noted generalized clammy skin, no skin lesions, rash or hives noted. respiratory rate WNL, respirations even and unlabored. Within less that 60 seconds patient started to regain alertness and was able to respond and answer questions appropriately. Reported feeling some anxiety prior to getting vaccine but denied being diagnosed or treated with anxiety. reported prior episode with similar less severe symptoms associated with "shots" within >2 minutes patient was A&O x4, verbal and able to make needs known. Respiration remained even and unlabored. Skin pink warm and intact with significantly decreased clamminess and diaphoresis. No sx/sx of allergic reaction. Chest is non-tender, initially bradycardia @ 43 BPM, noted irregular heart rhythm, no murmur or extra sounds noted. Pt reports playing football with practicing at least 4 days weekly. Denies significant past medical HX. No HX of allergies.  Patient was assisted to yoga mat on ground, in supine position with lower extremities elevated. Physical assessment completed then past medical HX obtained from PT. Initial VS 100/50. HR 43, o2 96% ECG obtained by EMTS WNL. Spontaneous resolution of symptoms after 1-2 minutes. Patient was assisted to sitting position, then standing w/o return of symptoms. VS @ 5 mins 114/63 HR 63 RR 18 o2 98%. Patient escorted to observation area and sitting in chair. Patient was observed for 30 mins in observation area. After 30 minutes no acute distresss noted, pt denied pain, dizziness, tinnitus or other symptoms. Advised patient to abstain from strenuous activity for the rest of the day and advised against football practice today and against being alone today. Advised patient to seek emergency treatment by calling 911 should symptoms return, experience SOB, or any sx/sx of an allergic reaction. Patient verbalized understanding before leaving vaccine site @ 1610
Flushes hands and feet and tingling hands and feet 5 hours post vaccination. Muscle twitches/spasms started 4 days post vaccination. Headaches began 4 days post vaccination. Muscle fatigue began 4 days post vaccination. All symptoms are still present intermittently.
Bloching rash chest/abd/leg duration , area 0.5- 1 cm
7JUN94 recvd vax & 8JUN93 AM t105, cranky, evening 1-2 mins of pale, dec responsiveness; 9JUN93 has done well no further sx;
Severe headache, fever and pain in both legs. Will need to be on Eliquis for 2 weeks. She also mentioned she got Pfizer 7 weeks ago but they ran out of the vaccine so she couldn't get her second dose.