chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of influenza in a female subject of unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergies, asthma, chronic obstructive pulmonary disease, high blood pressure, rheumatoid arthritis and cholesterol "problems". Previous and/or concurrent vaccination included Influenza vaccine trivalent; GlaxoSmithKline; unknown; unknown given in 2010. Concurrent medications included Vitamin; Prednisone; ADVAIR diskus; Ibuprofen; YASMIN; Calcium; Spironolactone; Hydroxychloroquine; Folic acid; HYZAAR; LYRICA; DETROL LA; ENBREL; Morphin; Oxycodone; Unknown; REQUIP and CRESTOR. On unspecified dates every year since 1997 and on an unspecified date in 2007 the subject received a dose of Flu vaccine (unknown). Every year since 1997, one day after vaccination with Flu vaccine, the subject experiences erythema, swelling and pain. It was reported that "since 1997 the subject has had flu vaccines every year in the fall after which she develops a reaction of redness, swelling, and pain in the arm around the next day after the injection. After a week, these symptoms usually go away". Approximately three years ago in 2007, one week after vaccination with Flu vaccine, the subject experienced influenza, vomiting, fever, and nausea. "Three years ago after her regular flu shot, a week after this particularly injection, patient got really sick with the flu. The physician then said that she must have had the flu infection inside her when she got the flu vaccine and that is why her flu infection surfaced so shortly after the injection. This flu infection three years ago resulted in vomiting, fever, and nausea. Most recently she had a FLULAVAL vaccine and she didn't not have any of these usual localized reactions that she gets normally". At the time of reporting the outcome of the influenza, vomiting, fever, and nausea that occurred in 2007 were unspecified. The outcome of redness, swelling, and pain every year since 1997 usually resolved after approximately one week.
100.0 fever; Chills; body ache; left armpit lymph node; site of injection sore; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El3247) via unspecified route of administration on Left arm on 16Feb2021 (at the age of 32 years old) as single dose for COVID-19 immunization at workplace clinic. The patient medical history was none. The patient had no known allergies. Concomitant medications included ethinylestradiol/ norgestimate (SPRINTEC) and escitalopram. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El2347) on Left arm on 27Jan2021 01:45PM for COVID-19 immunization. The patient did not receive any other vaccines in four weeks. The patient did not have COVID prior vaccination and did not tested for COVID post vaccination. On 17Feb2021 at 02:00 AM, the patient experienced chills, body ache, left armpit lymph node, site of injection sore, fatigue and 100.0 fever. The patient did not receive any treatment for the events. The outcome of the events was reported as received on an unspecified date in 2021.
Fatigue, low fever, nausea, headache, malaise, dizzy, lightheaded
Patient is a 63 yr/o female who presents to the emergency department complaining of dizziness since 0400 this morning. She endorses nausea, vomiting, and headache. Her symptoms are worse with position changes. She states that she has a hx of vertigo with her last episode being 11 months ago. She states that she does not normally have a headache with her episodes of vertigo, but today she developed one. Denies chest pain, sore throat, visual disturbance, or diarrhea. She reports chronic shortness of breath. She is a former smoker. Denies alcohol use. No other complaints at this time.
THE DAY AFTER VACCINATION PATIENT STATED SHE HAD INJECTION SITE SORENESS AS WELL AS NAUSEA, FATIGUE, AND HEADACHE. SYMPTOMS RESOLVED WITHIN A DAY.
broke out in rash all over the body;pt to have no more Hep B vax;
EKG changes (ST depression); I started feeling short of breath; tachycardia; fatigue; upper back/left scapula pain; upper back/left scapula pain; This is a spontaneous report from a contactable Physician (patient herself).  A 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm at age 44 years on 27Jan2021 15:00 (Batch/Lot Number: EL3246) as single dose for COVID-19 immunization. Medical history included alopecia and known allergies to peanuts. Patient is not pregnant. Patient had not had COVID prior vaccination. Concomitant medication(s) included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), spironolactone, VIT D, zinc, and biotin, taken on unspecified dates for an unspecified indication. Patient previously took dose 1 of BNT162B2 lot number= EL3246 on 08Jan2021 with administration time at 04:15 pm, vaccine location on the left arm. On 29Jan2021, 2 days after the vaccine, patient started feeling short of breath, tachycardia, fatigue, and upper back/left scapula pain. Patient thought she had some side effect that eventually would go away. By 02Feb2021, she felt worsening tachycardia, fatigue and shortness of breath. Patient went to (Hospital name withheld) and they did a COVID 19 test on Feb2021. The test was negative but they found that she was very tachycardic and EKG changes (ST depression). Then, patient underwent a cardiac catheterism and a CT angio of the chest and both were negative. Patient was discharged 24 hours later still tachycardic up to are of 110s. As outpatient, patient underwent echocardiogram and was negative as well. Patient  saw her cardiologist on 19Mar2021 and it seems that the tachycardia resolved along with her fatigue and upper back pain. All these symptoms gradually improve over time. She still have the ST depressions on her EKG but she was asymptomatic. No one was sure if she had any sort of immunologic reaction to the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. Treatment was heparin, aspirin and ticagrelor (BRILINTA).  The outcome of the event EKG changes (ST depression) was not recovered, while for the rest of the events, it was recovered on 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a physician, via a company representative, concerning a 23 year old female patient with drug hypersensitivity to Wellbutrin who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil (Lot #656050/0245U). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2007, after the vaccine was administered, the patient fainted, the patient confirmed that she had not had breakfast before the vaccination was given. The physician reported that the patient recovered on the same day. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician, concerning a 23 year old female patient with drug hypersensitivity to WELLBUTRIN, contact dermatitis and seasonal allergies, who on 03-APR-2007 was vaccinated with the first dose, 0.5ml, IM, of GARDASIL (Lot #656050/0245U). Concomitant therapy included hormonal contraceptives (unspecified). On 03-APR-2007, after the vaccine was administered, the patient felt dizzy and "had a syncopal episode". The patient, who confirmed that she had not had breakfast before the vaccination was given, was moved to the exam room, monitored and given a drink. The physician reported that the patient recovered "within a half hour". No further information is expected.
Gave MMRV instead of MMR to patient. No symptoms, signs or adverse effects. No treatments.
Since Jan 2020 I have been experiencing positional/vasovagal fainting spells once every 4-6 weeks.  They tapered off and were manageable.  Since 3/6/2021, I have had 7 episodes, 5 of those since 4/2/2021, two weeks after my second vaccine.  My family suggested I look thru my journal to see what could have triggered this explosion in events.  My physician contact was thru messaging.  I don?t go out much and had only two social interactions during that time period.    I had my second Pfizer vaccine at same location on 3/18/2021 at 4 pm; lot number EP7534
fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left clavicle that sore; This is a spontaneous report from a contactable health care professional nurse, the patient.  A 59-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL 3246), via unspecified route of administration in the left arm on 20Jan2021 at 13:00 (at the age of 59-years-old) as a single dose, for COVID-19 vaccination. Medical history included asthma (Chronic Asthma but controlled). The patient had no known  allergies. Concomitant medication included Albuterol, Singular, Zyrtec, multi vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 25Jan2021, The patient experienced fatigue,  swollen lymph nodes above the left clavicle that sore. Reported non serious adverse event of fatigue, swollen lymph nodes above the left clavicle that sore and still present on 27Jan2021.  No treatment was given for the events. The clinical outcome of the events fatigue,  swollen lymph nodes above the left clavicle that sore was not recovered.
At 10:46 patient stated that she was feeling light headed while sitting in postvac. States she did not eat or drink  this morning other than a sip of gatoraid to take her birthcontrol pill. BP 126/66, HR 80, rr 18. Gave her a drink  of water. 10:54 states feeling less "lupey but still has a few floaters in vision" she did not state this when asked at on set. States she experienced light headedness in 2018 when she had blood drawn but that she does not  have a fear of needles. 1102 bp 122/62, rr 16, hr 74. Patient education provided and she signed and gave  verbal that she understands instructions. Left clinic on her own at 1106.
Booster; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 11:45 (Lot number: FH8030) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 11:45, outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 27Nov2021, outcome "recovered" (Nov2021), described as "Chills". Therapeutic measures were not taken as a result of chills.  No follow-up attempts are possible. No further information is expected.
Generally didn't feel well; Aches; Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (Generally didn't feel well), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient was hospitalized for Covid-19 the last week of May and was treated with monoclonal antibody therapy.). Previously administered products included for an unreported indication: BAMLANIVIMAB and REMDESIVIR.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Generally didn't feel well), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Generally didn't feel well), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fever) 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.   Concomitant product use was not provided by the reporter.
developed progressively severe right flank pain and back pain on 1/1.  Went to emergency department on 1/6/21 d/t severe pain (no fever, diarrhea, nausea or vomiting).  ED md stated it was potentially shingles.  Have had similar outbreak of shingles (no rash but severe right flank and abdominal pain approximately 12 years ago and was seen in same ED and the dx of shingles was made by the PA in Dr office).  Pain improving as of today 1/11/21.  Have been unable to tolerate the increased dose of the naproxen prescribed by the ED md d/t increased gastric irritation.
patient was given janssen  covid- 19 vaccine at 4.30 pm and 10 min later the patient fell forward from his chair on his face as he felt very dizzy and sweating.. Patient regained consciousness right away and was doing fine after a few min.
Began experiencing fainting spells, extreme low blood pressure and dizziness.  Had been very healthy prior to vaccines and booster, running, working out, hiking.  Now, not able to walk around block.  Fainting spells frequent.
Injection site (L upper arm) pain started the evening after receiving injection. Pain worsened to a point where mobility affected by discomfort. Tx - ice, rest and pain medication. Will follow up in clinic in 1 week.
a few hrs p/vax pt became fussy; later that day, pt started screaming, grabbing but missing things, looking @ mom but looking past in the wrong direction, & stiffening (no sz); lasted approx 20 hrs; no treatment required;
cried for 15 min straight, vomited 3 times, became lifeless, pale and unresponsive
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received on 17-OCT-2022, from a Health Professional.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004182, MCM-004181, MCM-004184, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Anaphylaxis - hives, sensation of throat tightness, shortness of breath, sweating, hypertension, tachycardia Treated immediately at vaccine site with epi-pen, Benadryl 50mg with improvement in symptoms. Transported to the ER where symptoms subjectively were returning and treated with famotidine 30mg and IV Solumedrol 125mg. Monitored for 3 hours further in the ER and discharged home with prednisone taper and prescription for Epi-pen.
Received Flu vax at doctor's office by nurse. The shingles vax stung going in. By the afternoon arm started to throb and had to take medicine. Lesion, red, itching bad and raised. Lesion got worse overnight it feels solid, red about 6 3/4 by 4 1/2. Today it is itchy but too sore to scratch.
Symptoms: Full body hives + full body rash with no relief Time Course: began a week after vaccine booster, hasn't stopped. Medication Prescribed: Prednisone, 2 rounds of hydroxyzine, Xyzal  I felt flu-like symptoms about 24 hours after the shot which lasted 3-4 days. On the 7th day (Friday, December 17th,) I woke up with hives all over my body. I took Claritin, which soothed the hives for 24 hours, then they got worse.  By Monday December 20th, Claritin wasn't helping and by Tuesday, December 21st, the hives were so bad and my face was so swollen I couldn't put my glasses on. I was covered in hives and a red blocky rash from head to toe. Hives would pop up and go away within an hour, only to be immediately replaces by new hives. I went to an urgent care on Wednesday, December 23rd and the doctor there prescribed a heavy dose of Prednisone and hydroxyzine. The hives got a little better, but the rash stayed the same.  I didn't get better. I saw my GP on Monday, January 10th, who referred me to an allergist. The allergist informed me that the rash wasn't a rash, but hives that weren't breaking the skin. I am on 5 antihistamines a day (hydroxyzine and Xyzal) which stopped the hives, but the "rash" still appears.
Erythema, swelling, induration, pain, and warmth at site of injection. Pt also had fever of 100.0 po but that has now resolved.  Reaction continues to spread.  Vaccine give 5 days ago.
Mother stated 10 min after leaving the room, the client stated he was not felling well and  started shaking and his eyes rolled back into his head and he collapsed into her arms.
On 3/8/14 pt noticed a small red area on L upper arm. Area slowly became bigger over the next 2-3 days. Fever, chills and night sweats last night. Area L upper arm red, tender, warm to touch. Tx with Cephalexin 500mg, po 4 times 1 day x 10 days.
Information has been received from a physician referring to 5 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose and frequency unknown, lot# L03015, expiration date: 11-AUG-2017). No adverse symptoms were reported. Additional information has been requested.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired vaccine of Moderna COVID-19) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A) for COVID-19 immunization. No medical history reported. On Nov 8, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine, unknown route; 0.25 milliliter. On Nov 8, 2021, patient administered expired product (received expired vaccine of Moderna COVID-19). On Nov 8, 2021, administered expired product (received expired vaccine of Moderna COVID-19) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. No adverse event for the patient. Most recent follow-up information incorporated  included: On Nov 11, 2021: Document received on Nov 11, 2021 updated the narrative supplement.
Projectile vomiting with lethargy x 24 hours. Started 3 days after DTap vaccine.
Patient received first dose of Moderna on 01/12/2021 at Health Department. Appointment was made for patient to return on  Feb. 9, 2021 for 2nd dose. Vaccination card was given to patient. Patient thought he could receive in 2-4 weeks and was anxious to receive his 2nd dose so he returned to clinic on 01/26/2021 for 2nd dose. In oversight date of his first dose was overlooked and  2nd dose was administered  inadvertently.
I woke up at 1:30am Saturday with severe chills, temperature of 99.7, and headache. This continued all day until Sunday around noon.  I also vomited x2 due to nausea.
Information has been received from a registered nurse concerning an approximately 68 year old female with cauda equina syndrome and supraventricular tachycardia who on 18-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot #667912/0933Z) 0.5 ml single dose IM. Suspect vaccination at the same time, in the same arm included a dose of influenza virus vaccine (unspecified). Concomitant therapy included LYRICA, FLOMAX and atenolol. The registered nurse reported that the patient returned to the practice on 20-OCT-2010, complaining of swelling and tenderness below the injection site. Nurse reported that examination of the arm revealed an erythematous and swollen area, slightly raised, extending down to the elbow. At the time of the report, the patient was recovering. Physician's office would like a lot check on PNEUMOVAX 23 lot # 0933Z, expiring on 25-FEB-2012. A lot check has been initialized. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (667912/0933Z) in question were satisfactory. The lot met the requirements for the Center for Biologics Evaluation and Research and was released. Follow up information was received from the nurse concerning a 67 year old male patient who on 18-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # 667912/0933Z). The patient reported same pain on the left deltoid area on 19-OCT-2010. The physician noted area of erythema measuring 8 cm in the greatest dimension inferior to the injection site. The patient was given ZYRTEC 10 mg daily. The nurse did not agree the patient was inappropriately vaccinated. Follow up information from the registered nurse reported that the patient was recovered from the events on 22-OCT-2010. No further information is available.
Severe Itching mostly on trunk of my body, rash,  Have been using Cortizone Cream, have had 2 shots of Steroid a week apart, using over the counter cream for itching( not working very well.
Narrative:  THis is not an ADR, but a "breakthrough" COVID-19 Infection requiring hospitalization in an immunocompromised patient s/p 2 doses of moderna vaccine. This report will be forwarded to the FDA via the smart phone app
5DEC96 pt told mom arm bothers him;no pain but itches;5DEC96 samll (half dollar) reddened area on rt area w/4-5 small scabbed area;
pt recv vax; MD reported that pt devel immune thrombocytopenia following vax;
Vaccine received on a Friday, woke on Sunday as usual, as day went on I kept getting extremely tired.  Have been doing this each day since the vaccine.  Began a sore throat and tongue on Wednesday, 3-17.  Woke today and I'm almost raw deeper in my throat.  Almost blistery.  Continue to be exceptionally tired.
Pt received TDaP and influenza vaccines on 1/13/11. Developed back pain on 1/15/11 (severe) radiating down legs and bilateral leg weakness. Patient attributes this to H1N1 component of vaccine. Testing continues.
Woke up with stuffy nose, body aches and fatigue. Slept through first day. Muscle aches and bad feeling lasted 3 days. Nasal stuffiness lasted 5 days.