chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No symptoms or physical signs. Patient was administer the 30mcg/0.3ml dose instead of the 10mcg/0.3ml.  Patient turns 12 in less than 2 months
Mother states child started with slightly red, swollen (L) nose, face, eye on 12/29 - PM - On Fri 12/30/10 AM - worsened & on Sat 01/01/11 took child to ER in AM - Drs not sure why whole left side of face & eye & nose were swollen & had some nose bleed on (L) - "stuffy nose" - no resp. distress. Given BENADRYL PO Prednisone PO. Last day - 1/3/11.
red swollen area that itched a lot/it was speckled; red swollen area that itched a lot/it was speckled; red swollen area that itched a lot/it was speckled; tiredness; felt really lousy/ feeling bad/ felt like a bad flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL8982) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lost two inches/loosing inches" (unspecified if ongoing), notes: She has lost two inches. Caller clarified that loosing inches was prior to receiving the Covid19 vaccines.; "blood pressure" (unspecified if ongoing), notes: she takes regular medicines for blood pressure and thyroid for years.; "thyroid" (unspecified if ongoing), notes: she takes regular medicines for blood pressure and thyroid for years. Concomitant medication(s) included: AMLODIPINE;OLMESARTAN taken for blood pressure abnormal; LEVOTHYROXIN taken for thyroid disorder; ECOTRIN; BAYER ASPIRIN. Past drug history included: Flu shot, notes: she gets that every years. Vaccination history included: Pneumonia shot (had the life long pneumonia shot that she got several years back). The following information was reported: FEELING ABNORMAL (non-serious) with onset Jan2021, outcome "recovered", described as "felt really lousy/ feeling bad/ felt like a bad flu"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset Jan2021, outcome "recovered" and all described as "red swollen area that itched a lot/it was speckled"; FATIGUE (non-serious) with onset Jan2021, outcome "recovered", described as "tiredness". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pruritus, fatigue, feeling abnormal.  Additional information: Ecotrin is a coated Aspirin. Patient takes it daily and has been on it for years. If patient can't find it, she uses Bayer coated aspirin. patient does one or the other. The red swollen area and the tiredness appeared the next day or that night, patient can't remember. It was a two-day process where she felt really lousy. It probably showed up the next day. Patient remembers feeling bad but not enough to go to the doctor. It felt like a bad flu. With the second one her arm was worse. Ache in her arm: Patient never had the continual achiness until the second booster. She had achiness right after the shot, tiredness, and feeling bad with all the shots but she never had the heaviness or continual achiness until the second booster. She got the shots in her left arm because she is right-handed. This morning she can hardly move her arm. Patient doesn't take any pain medication ever no matter how sick even if it is prescribed, she won't get it filled. Patient doesn't believe in that. She only takes Aspirin.
chest pain: attempted to take tums in case it was heartburn, but that did not help. chest pain lasted about 4-6 hours. also had fatigue, chills, achiness which was expected and not a concern. but the chest pain is a concern and makes me afraid to get another mrna vaccine.
Had PREVNAR 14 months ago. Had PNEUMOVAX yesterday and had local reaction within hours accompanied by fever.
2 days p/vax pt awake w/severe h/a;c/o unable to walk & go to work d/t severe h/a;mom very concerned;pt did have syncope episode w/o hit head @ time of vax;
Patient describes a red irritated ring approximately 5 inches in diameter radiating from the injection site. Patient applied lavender ointment and was recovering. Patient stated the irritation was subsiding.
This case was reported by a healthcare professional via a sales representative and described the occurrence of rotavirus in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 16 March 2012 the subject received 1st dose of ROTARIX at 1 ml, oral. On 19 March 2012, 3 days after vaccination with ROTARIX, the subject experienced fever, diarrhea, vomiting and dehydration. On that same day, 19 March 2012, the subject tested positive for rotavirus vaccine. At the time of reporting the outcome of the events was unspecified.
Pt experienced large local reaction after receiving pneumococcal and flu vaccine in the same arm. Also has been running temp of 102.
This serious spontaneous case, was initially received on 05-Oct-2017, reported by other-health professional, and concerns a 61-year-old, adult, female patient. The patient was allergic to shellfish, sulfa, latex, antibiotics, and aminoglycosides. The patient's concomitant medications included: BENADRYL and URSO. On 05-Oct-2017, the patient received AFLURIA QUADRIVALENT for the first time (dose: 0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: XF31007, expiry date: 30-Jun-2018). On 05-Oct-2017, 3 minutes after administration of the suspect vaccine, the patient turned pale which was noticed by the nurse (nurse who administered the vaccine and the nurse who identified the symptoms was not the same) and asked whether she was okay. The patient felt her throat itchy, not fully anaphylactic. The patient became hypertensive (170/110), normally her blood pressure was low. The patient was taken to the emergency department and treated with BENADRYL (25 mg, q4h, IV (intravenous)) and PEPCID which helped to lower her blood pressure. She was also treated with ZANTAC and she felt like she was vasoconstricted. She was sent home with oral BENADRYL, which worked to treat the event. On an unspecified date, the patient recovered from the events. Follow-up received on 17-Oct-2017: Route of administration was updated to intramuscular. Dose and frequency of treatment medication BENADRYL was updated to 25 mg, q4h. ZANTAC was added as treatment medication. Outcome of the events was updated to recovered from recovering and narrative was amended accordingly. Non-significant case correction received 05-Oct-2017: Batch number (XF31007) was captured on the screen and narrative was amended accordingly.
3 inches by 3 inches local redness and mild swelling on injection site.  Treated with warm compress and was given Zyrtec, allergy med by mom.
Severity of symptoms were such that I would have gone to an ER if it weren't vaccine related.  Symptoms onset within four hours of vaccination were severe joint, muscle, sternal, neck and back pain. Chest pain with SOB and sore throat. Severe chills. Severe fatigue.  On 03/25/2022 a painful 2x3 inch painful lump was present in right axilla. Pain in upper sternum with breathing and mild SOB. Appointment with physician on 04/28/2022 dx lymphadenopathy.  Ordered mammogram and right breast ultrasound axilla only and NSAIDS. As of 04/19/2022 still waiting for ultrasound and mammogram.
Symptoms of COVID 19 on 20May2022; Positive COVID test 24May2022; Symptoms of COVID 19 on 20May2022; Positive COVID test 24May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: EP7534), on 21Apr2021 as dose 2, single (Lot number: EP7534) and on 20Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 21 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "Mild cerebral palsy" (unspecified if ongoing), notes: Mild cerebral palsy. Concomitant medication(s) included: QUETIAPINE FUMARATE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20May2022, outcome "unknown", COVID-19 (medically significant) with onset 20May2022, outcome "recovered" (28May2022) and all described as "Symptoms of COVID 19 on 20May2022; Positive COVID test 24May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: COVID-test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course included patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Symptoms of COVID 19 on 20May2022; Positive Covid test 24May2022. Symptoms lasted through 28May2022. No prolonged hospitalization, No known allergies reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination,  patient not tested for COVID-19.
Shingles Outbreak. Currently being treated for Postherpetic Neuralgia with epidural steroid injections.
Shingles advanced to eye. IV Acyclovair-  Emergency admitted to hospital for one week. No resolution.
Approx 3 hrs p/inject c/o feeling hot became pale, legs buckled & feel to floor; arms & legs were stiff, back sl arched, eyes open & staring x 1 min; taken to MD who felt was caused by stress rxn;
On 7/23/2001, had 4 injections. Mom's history; on 7/28/01, pt had slightly swollen left thigh for 5 days, post vax; on 8/1/01, it was very swollen and tender for 9 days, post vax. At the other facility, on 8/2/01, pt had golf ball-sized lump on left thigh that was firm and slightly tender to touch. Pt was referred to pediatrician for evaluation. He evaluated pt and said he had  a 2cm X 2cm firm mass on left thigh and it was not likely to be a reaction to shots but would hold next Prevnar.
SWELLING OF THE FACE; GENERALIZED ITCHING; HIVES ALL OVER HER BODY; FEVER; CHILLS; This spontaneous report received from a patient concerned a 66 year old female. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 15-MAY-2021, the subject experienced hives all over her body. On 19-JUN-2021, the subject experienced swelling of the face. On 19-JUN-2021, the subject experienced generalized itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 10-APR-2021, and had not recovered from hives all over her body, swelling of the face, and generalized itching. This report was non-serious.
Not feeling well; High blood pressure; This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (Not feeling well) and HYPERTENSION (High blood pressure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well) and HYPERTENSION (High blood pressure). At the time of the report, MALAISE (Not feeling well) and HYPERTENSION (High blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (High) High blood pressure..     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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Post herpetic neuralgia; Lichen Planus; Multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia and lichen planus. As a result of these symptoms, he was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using this product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of this conduct, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, postherpetic neuralgia and lichen planus was not recovered. The lawyer considered the events to be related to zoster vaccine live(ZOSTAVAX).   The events of herpes zoster, postherpetic neuralgia and lichen planus were assessed as disabled by the lawyer.
States got nauseated/vomited 24 hours after the vaccine  Client went to her primary physician to be checked out on 1/20/21 at 1:00pm with her son who reported her adverse reaction to her doctor and the health department.
Both MMRV (Proquad) and Varivax were administered to patient.
Patient states she is having chest pain, sob, and dizziness. Did not resolve after 30 min wait. Transported to ED. Provider notified.
Immediately after administration of the vaccine the patient reported feeling flushed, rapid heartbeat and because of her previous history of reaction to chemicals she became anxious. Pt further evaluated by NP and pt c/o itching to back of throat. No SOB. At time of NP evaluation heart rate within normal limit, 84. Alert and oriented. No acute distress. Pt very anxious. Pt monitored for one hour with no issues or emergent care needed.
PATIENT WAS ADMINISTERED FLULAVAL APPROX.  1440 HAD A SYNCOPE EPISODE; WAS CLAMMY, DIAPHORETIC PATIENT WAS IMMEDIATELY BROUGHT TO BY FACILITY. PATIENT WAS A&Ox3. PATIENT WAS PLACED ON BED, HEAD WAS CHECKED FOR BRUISING. PEDIATRIC RAPID RESPONSE TEAM WAS CALLED AND MACE EXAM WAS PERFORMED. PATIENT WAS ON HIGH FLOW O2 FOR 5 MINUTES AS A PREVENTATIVE MEASURE.  @1450: B/P: 86/52; 70 BPM; 100% SPO2 @1500: B/P: 83/53; 68BPM; 100% SPO2  PEDIATRIC RRT CLEARED THE PATIENT TO LEAVE THE SITE. RECOMMENDED A VISIT TO THE ED IF ANYTHING CHANGES WITH THE CHILDS HEALTH.
I did get sick a week later; Initial information was received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional.  This case involves an unknown age and unknown gender patient who had an event, "i did get sick a week later" after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).     On an unknown date the patient developed a non-serious event of I did get sick a week later (illness) (unknown latency) following the administration of influenza vaccine.  No lab data were reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Hospitalization for Acute Repiratory Failure due to COVID-19 on dates 11/28/2022- 12/5/2022. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Small rash on my left bicep. This particular rash occurs occasionally for me, but I'm not sure what causes it.
Chills, exhaustion, increased D-dimer, severe redness and bruising at injection site and pain, lymphadenopathy. Sent to the hospital for chest x-ray with shortness of breath and increased D-dimer
Fever 100.5 on 10/9/09. 10/10/09->area of erythema and induration 7 1/2 x 10 cm. Local reaction vs cellulitis. Treated with KEFLEX.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  This case concerns a 67 year-old, female patient with a history of Multiple sclerosis and concomitant use of ocrelizumab, who experienced the non serious unexpected AESI of COVID-19. The event occurred approximately 7 months after the first dose of mRNA-1273 vaccine. The re-challenge was not applicable. The medical history, of Multiple sclerosis and concomitant use of ocrelizumab remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 67 year-old, female patient with a history of Multiple sclerosis and concomitant use of ocrelizumab, who experienced the non serious unexpected AESI of COVID-19. The event occurred approximately 7 months after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable. The medical history, of Multiple sclerosis and concomitant use of ocrelizumab remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient presented with bloody stools, abdominal pain, lethargy on afternoon of 8/16/2019.  Per mom patient had been lethargic and didn't want to eat much all day.  Sent to ER for evaluation.  Diagnosed with intussesception, successfully reduced by air-contrast enema on third attempt, patient monitored overnight and discharged home the next day.
severe abdominal pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's fiance) reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization on an unspecified date. It was reported that the patient got her second dose today (11Jan2021); however, she experienced a severe abdominal pain on an unspecified date. Outcome of event was unknown.  Information on the batch/lot number has been requested.
Case number PHEH2015US017809, is an initial spontaneous report received form a nurse on 09 Sep 2015. This report refers to a 16 year female patient. Past medical history and concomitant medications were not reported. She was vaccinated with expired Men A lyophilized conjugate (batch number: A14057 and expiry date: Aug 2015) component of MENVEO (batch number and expiry date: not reported) on 03 Sep 2015. It was reported that, MENVEO was prepared with both portion of the vaccine correctly mixed and administered. No adverse event was reported following this administration error. No other information was reported at the time of this report. Follow-up information received on 13 November 2015: Previously administered products included meningococcal vaccine, administered on 30 Aug 2010. On 3rd September 2015, the patient received MENVEO (intramuscular) .5 ml. Diluent was expired since August 2015. On 10 September 2015, the patient returned to office and was re-vaccinated with MENACTRA.
Body aches; Heighten skin sensitivity; Nausea; Dizziness; Loss of balance; Elevated heart rate; Severe fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included drospirenone and ethinyl estradiol (GIANVI) from an unknown date for birth control. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 15:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 02:00 the patient experienced chills, body aches, heighten skin sensitivity, dizziness, loss of balance, elevated heart rate, severe fever and nausea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, body aches, heighten skin sensitivity, dizziness, loss of balance, elevated heart rate, severe fever and nausea was not recovered at the time of the report.  No follow-up attempts are possible; information about the lot number cannot be obtained.