chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had anaphylactic reaction/throat and mouth swelled so much dentures pushed out of the top; This is a spontaneous report from a contactable nurse. A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8734, expiry date unknown), intramuscular, administered in the left arm on 02Apr2021, dose 2, single for COVID-19 immunization.  Medical history included coronary artery disease (CAD), hypertension (HTN), arthritis, atrial fibrillation, diabetes mellitus (DM), breast cancer which was in remission all from an unknown date and unknown if ongoing. Concomitant medication included isophane insulin (NPH INSULIN); potassium (manufacturer unknown); sertraline (manufacturer unknown); levothyroxine (manufacturer unknown); acetylsalicylic acid (BABY ASPIRIN); calcium (manufacturer unknown); trazodone (manufacturer unknown); dicyclomine (manufacturer unknown); famotidine (PEPCID); insulin human injection, isophane (NOVOLIN N); carvedilol (manufacturer unknown); magnesium (manufacturer unknown); vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]), all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamide and codeine and experienced allergy. The patient previously received the first dose of bnt162b2 (lot number: EN6208), intramuscular on 12Mar2021 at 07:30 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Apr2021, seven days post the second dose of the Pfizer vaccine at 19:30, the patient had anaphylactic reaction to shrimp in which she never had this reaction ever before, eating shrimp all the time, eating other items in the dinner all the time, throat and mouth swelled so much dentures pushed out of the top. The patient's husband called EMS and the patient was given Benadryl x 2, epi x2, shots x2, was intubated and woke up two days later in ICU. The patient's allergy and blood tests were negative for any possible food allergies that she had consumed on that day. The patient's doctor stated this event could have been absolutely related to the vaccine. The event resulted in a visit to the emergency room/department or urgent care and was hospitalized for 10 days. The patient received epinephrine, magnesium, antihistamine and steroids as treatment for the events. The patient was intubated and placed on a ventilator. The patient has not recovered from the events. The events were considered as a life-threatening illness (immediate risk of death from the event).; Sender's Comments: Based on the information currently available and the known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported anaphylactic reaction cannot be completely excluded. This case will be reassessed upon receipt of additional information.
6-17-11 awoke with rash. Took BENADRYL. On 6-19-11 developed difficulty breathing. Saw PCP on 6-20-11 & received cortisone injection & Prednisone po x 6 days.
Red rash resembling dermatitis on and around the injection site about one week after the shot. No other symptoms accompanied this event
extreme chills, temp 100 F, teeth chattering, body aches and pains, bright red splotches on face that persist to this day/time (Jan 15, 2021 3:36PM).
SORE THROAT; STUFFY NOSE; SNEEZING; COUGHING; FEELING HOT; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore throat, stuffy nose, sneezing, coughing, feeling hot, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, stuffy nose, sneezing, coughing, headache and feeling hot was not reported. This report was non-serious.
Welts, redness, itching on the skin. Arms, legs, abdomen. beginning 5 days after vaccine , continuing on days 6,7. Self treatment with diphenhydramine and cortisone cream.  No new soaps, lotions, laundry detergents were used. No new medications or foods were ingested.
red and slightly warm to touch at injection site, tender if bumped  advised patient 7/11/11 that Tylenol can be taken for the pain
palms of hands became red & itching & hands became swollen lasted 20min;no SOB;
Noticed AM 1/15/09 - Right upper arm redness, pain and swelling to hand, red raised area noted surrounding injection site, seen by attending, given script for DOXYCYDINE
This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. The patient received his first dose of GARDASIL 9 from a single-dose vial on 09-JUN-2015 and on 04-SEP-2015, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly (unknown dose) from a single-dose vial. Concomitant medications were not reported. On 04-SEP-2015, the GARDASIL 9 leaked out of the plastic syringe during administration of this second dose due to a crack at the bottom of the plastic syringe. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
After 4 month shots, the baby had a temperature of 101F and about 3 hours of fussiness. Had decreased tone and staring spells intermittently. Also with bursts of crying and stiffness lasting about 1 minute. Baby "fine", mother says.
swollen lower lip; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 11Mar2021 at 09:00 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. Medical history included fillers in lips about 6 months ago. There were no concomitant medications. The patient previously received the first dose of BNT162B2 administered in arm left on 15Feb2021 at 09:00 AM (at the age of 67-years-old) for COVID-19 immunisation. The patient experienced swollen lower lip on 13Mar2021 at 05:00. There was no treatment received for the event. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Physician called about patient with flu-like symptoms related to smallpox vaccine. He had placed patient on Symmetrel but thought her symptoms were related to vaccinia. He saw patient on Day 4 after vaccine innoculation of smallpox and what he believed to be celluitus and treated with Keflex.  He sated that the site was better soon after and antibiotics were disconutined.  Dr. reminded Dr. not to use acetone or alcohol to clean the vaccine site because the virus is fastidious and this would interfere with a take and was concerned that this employee developed a cellulitis with only minimal instrumentation of site.  Dr. suggested that he consider Staph carriage in his patient or that the response might have been related to other vaccine issues (tape, allergic, etc.)  The patient complained of pharynigitis on 3/6/03 and ear pain  and he noted some cervical nodes.  Dr. stated that this was not typical for a vaccine response.  He noted that he elected to provide treatment with Zithromax pack.
was breathless; Increased Heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Increased Heart rate) and DYSPNOEA (was breathless) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (Increased Heart rate). On an unknown date, the patient experienced DYSPNOEA (was breathless). At the time of the report, HEART RATE INCREASED (Increased Heart rate) and DYSPNOEA (was breathless) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Medications were not provided by the reporter.
Case completed primary Covid vaccine series and booster, then was hospitalized for COvid. Hospitalized at : Hospital.  First hospitalization 3 days Acute hypoxemic respiratory failure due to COVID-19   Assessment & Plan Hypoxia was due to covid pna. Resolved. Subjectively much improved. CRP mildly elevated. Vaccinated with a booster. Day 4 dexamethasone and remdesivir. Discharging home to complete a course of dexamethasone.  Second hospitalization 17 days: COVID-19 Assessment & Plan Re-admitted with Covid related complications including weakness and failure to thrive. He is no longer hypoxic, steroids stopped on admission (he completed 5 days of it). Lost his sense of taste and smell and has had decreased p.o. intake. Encouraging po intake, supportive care, PT/OT.
RIGHT AFTER RECEIVING VACCINATION PATIENT PASSED OUT THEN VOMITED A FEW MINUTES LATER.  SHE HAD SOME WATER AND 15 MINUTES LATER FATHER TOOK PATIENT HOME. CALLED TO THE PHARMACY 30 MINUTES LATER TO SAY SHE WAS FINE
Onset of chills/fever about 10 hours after injection. Duration of chills/fever, about 10 hours. (No access to thermometer during this time but, based on past experiences, not a high fever.) Redness/tenderness centered about 6 inches below injection site, and towards the front/inside of arm: onset about 1 day after injection, growing for about 2-3 days, now subsiding after 5 days. Minor arm ache, but not limiting movement.  Achy joints when in fever/chills stages. Also some insomnia. Diffuse headache and low-level nausea, about 5 days. Mostly gone now, after 5 full days.
A report has been received from a Health Professional concerning a 29 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent stared on 19-DEC-2014. The patient has been administered expired FLUMIST Quadrivalent on 19-DEC-2014. The outcome of the event of patients have been administered expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
Shortness of breath, pain/redness on top site of injection ((R) deltoid), feeling weak and tired. Fever, swelling on the site.
Rash mild prickly with redness, started on upper extremities and spread to trunk back and lower extremities. Rash onset 5/16/06. comment-MMR given related to mumps outbreak.
Arm very tender/bruised feeling immediately after vaccination for 5 days. Evening following vaccination, I woke up in the middle of the night with a headache and body aches. Day 1 After: I had headache, body aches, muscle pain and joint pain, extremely tired the full day.  Day 2 after: Headache and tiredness was gone but the body aches and muscle aches continued. Day 3: body and muscle aches. Day 4 body and muscle aches improving but GI upset including nausea. Day 5: Aches mostly  gone but continued GI upset and diarrhea . Day 6 feeling well.
RASH OF LEFT DELTOID/ALLERGIC REACTION TO FLU SHOT PER DR. HYDROCORTIZE 0.5% BID X 7 DAYS PER DR. NO FLU SHOTS.
Not feeling well; This non-serious case was reported by a physician and described the occurrence of feeling unwell in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Not feeling well).  The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR132349   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter reported that the patient received Shingrix vaccine and experienced not feeling well. The reporter did not specify the nature of his not feeling well but stated that it was lasted for a couple of days. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR132349:Same patient/ Shingrix dose second
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: fainted immediately after injection
Cold sore on lip - used OTC abreva, it is still healing. It has been years since I have had a cold sore. I am not sure if it is related to the vaccine, but thought I should report it for more information.
After my second vaccine I did not feel well, I did have weird shooting pain down my arm, I had a lot of fatigue. My legs started swelling. I got diagnosed with stage 3A kidney disease.
Later the night after the vaccine  my back, neck and upper shoulder was stiff and sore. I had a very severe headache, was fatigued and super tired. My lower back got better within about 3 day, but my neck muscles and right foot was sore and has remained that way since the vaccine. After about 3 days I began having hives on the back of both ears and healed after about a week. I visited my PCP in March and advised him it felt as if my Lymph nodes were swollen, but during my Dr.s evaluation that was ruled out. A CBC was performed and my White Blood Count was low resulting in me being referred to a Hematologist/Oncologist. The end of March I visited the Hematologist who has performed several blood test which further showed the WBC level to be very low. I have visited with the Hematologist about 6 different times with CBCs done each time and to date the WBC just wont come back up. About 3 weeks after the 1st set of hives left they returned again but on my neck this time with less intensity and are still there to date as well. I have a weird feeling of pressure inside my neck feeling like my lymph nodes are swollen.
I had a cough, shortness of breath, and body aches. I tested positive for COVID-19 at home. I am a physician, so I prescribed myself PAXLOVID. After 24 hours of taking the PAXLOVID my symptoms started to clear up.
Increasing pain at injection site followed by itching at injection site and progressing to large area of urticaria covering injection site and shoulder with white spot at site of injection. Progressed to diffuse hives across chest, up neck, covering face and head with swelling including swelling of lips. Sought medical attention by agency Medical Director and on phone with PCP then to an urgent care center. Course of treatment included prednisone and antihistamine for 6 days.
abnormal bruising; swelling started at night; This is a spontaneous report from a non-contactable other health care professional. An unspecified age and gender patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and received hyaluronic acid, lidocaine hydrochloride (Juvederm Volbella with lidocaine injection, Batch/Lot number and Expiration date was not reported), via unspecified route of administration, on an unspecified date for an unspecified indication. Patient took COVID-19 vaccine 3 weeks before the Juvederm Volbella with lidocaine injection. The patient's medical history was not reported. Patient received pre-treatment of numbing cream as concomitant medication. On an unspecified date, patient was injected with Juvederm Volbella with lidocaine injection under eye and voluma in checks jawline temples nasolabial and patient had abnormal bruising immediately after injection and swelling started at night. On an unspecified date, after 10 days, patient developed product aggregation in jaw angle and cheeks and under eye. Therapeutic measures were taken as a result of abnormal bruising and swelling started at night and treatment included post treatment of vitamin K. Record related to Juvederm Volbella with lidocaine injection. The outcome of both the events was not recovered.  No follow-up attempts were possible, information about lot/batch number could not be obtained
Developed a rectal temp of 103.0 24 hrs after administration of vaccinations.
Patient received Prevnar and FLuzone HD vaccination on 10-20, patient reports that redness began on day of vaccine but continued to spread over the next few days until arm was bright red from shoulder to elbow.
pt recv vax & devel redness @ the inj site;no tx necessary;pt recovered;
Pt woke with a large red, painful inflamed lesion at vaccine site that was given yesterday 6-28-11. The raised site measured approx 3 inches in length and 2 inches in width. No fever or shortness of breath noted.
Patient received his first Moderna vaccine 3-19-21. He was due for his 2nd dose 4-16-21. We followed up with his sister due to missed appointment and was informed that he passed away 4-15-21 due to a blood clot.
Left arm became extremely sore around 6pm day of vaccination, by 11pm dealt with chills. Woke up various times throughout the night due to fever and sweats. On 3/28 woke up with fever of 101 and headache as well as arm pain.
Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of headache, chills, tiredness; Evening of 1/12 at about 6:30 pm diarrhea approximately 5 - 6 times and febrile about 99.3 (normal temp is around 96.8 - 97.4); Night of 1/12 about 11:00 pm got very dizzy, bad nausea, headache worse and this continued until about 3:30 - 4:30 am on 1/13; day of 1/13 chills and headache continued throughout day, lessening by early evening; Evening of 1/13, about 8:00 pm developed rash on head, face, neck and chest and took a Benadryl, which knocked me out and given no sleep the night before, I slept until noon of Thursday and returned to what I consider full health by 4:00 pm, about 72 hours after receiving the shot.
Patient received Janssen, he had brief loss of consciousness when being monitored for possible adverse reaction. He was sweaty, clammy and complained of dizziness when regained consciousness. Hypotension noted with BP less than 90 for diastolic. He was shaky and confirmed not having a meal for the whole and has a big fear on needle.  Snack was offered and pushed fluid, VS normal when rechecked, left the clinic Alert and oriented.
Nausea started before I left clinic.  at home migraine started.  I had premedicated with Zofran, Tylenol, Pepcid.  this time only lasted 3 Days.  though needed to con't with Sumatriptiline, and Zofran at time for 3 days after the original 3.  week later noticed lump tender in Left Axilla.  This is still present and after booster on 11/16/21 was consistently tender.  now only tender when touched.  size has decreased to about 2 cm.    Email sent to my physician for more Zofran as I was running low.-unsure of date.
t99 R; day 17 pt devel swelling lt cheek, afebrile, no pain, minimal fussiness; seen in office on day 18 following MMR w/lt parotid gland swelling w/o facial & cervical swelling;
pt recv vax & devel herpes zoster w/a T1, T2 dermatomal distribution of a vesicular papular rash & greater than 50 lesions;pt asymptomatic w/maximum T99;
FACIAL SWELLING AROUND THE LIP AND JAW, ALSO SOME WHEEZING.
Awoke on 10/22/02 with "fiery red rash" at back and abdomen, with center papules. Red area waws along at each site. This did not seem to bother child, per parents. No change in behavior, sleep or eating habits. No fever or sign of illness at 10/29-10/12 small (<1mm) papules remained at chest and back; Vss.
I had cough, SOB, no fever, headache, diarrhea, the hair on my head hurt, loss of appetite and everything tasted like salt, indigestion terrible, fatigue and the corners of my mouth split.
3 bad bloody noses 48 hours of vaccination; Extreme tiredness; Loss of appetite; Fever; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 07May2021 at 14:00 (at the age of 21-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for birth control from an unknown date and unknown if ongoing. The patient previously received amoxicillin/ clavulanate potassium (AUGMENTIN) for unspecified indication from unknown date and experienced drug allergy. On 07May2021 at 19:00, the patient experienced 3 bad bloody noses in 48 hours of vaccination, extreme tiredness, loss of appetite and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme tiredness, loss of appetite, fever and 3 bad bloody noses was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Secondary Transmission Nonvaccinee Limited information available - Primary SPV vaccinee had vaccine on 2/22/03. Approximately 13 days later, his wife (age 23) noted a lesion on her lateral forearm near elbow; she had axillary lymphadenopathy. The lesion became a blister which was pruritic and oozed. (Left a scar.) Prior to transmission, they had been sleeping together, and his gauze bandage had fallen off and his vaccine site touched her arm. Week prior to appearance of lesion, they were spending an average of 5-8 hours/day together. She did assist with his dressing changes, but wore gloves and washed hands after disposing of soiled bandage. He covered site either just with a gauze bandage, or with a bandage and a short-sleeved shirt
Reporter describes low grade fever (99.1-100F) and lower extremity body and joint aches starting approx 14.5 hours after receiving the vaccine and lasting 36 hours.  Treated with acetaminophen and ibuprofen.  Injection site was sore x1 week - "felt like there was a baseball" in arm.