chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 18-years-old male patient of an unspecified ethnicity received first dose of TRUMENBA, via an unspecified route of administration in left arm on an unspecified date at single dose for immunisation, and second dose of MENACTRA, via an unspecified route of administration in left arm on an unspecified date at single dose for immunisation. Medical history included syncope related to heat and dehydration. The patient's concomitant medications were not reported. The patient passed out (medically significant) on an unspecified date with outcome of recovered, shaking/trembling (non-serious) on an unspecified date with outcome of recovering , vision blackening (non-serious) on an unspecified date with outcome of recovering, he felt weak (non-serious) on an unspecified date with outcome of recovering. The patient walked to reception area, felt vision blackening, then passed out. Was passed out for about 45 seconds and awoke. He felt weak, tried to get him to stand to get blood pressure, started shaking and trembling again, so laid him back down for about 20 or 30 minutes. Gave him some water (about 4 glasses). Was able to stand. Called mom about an hour they left and reported he was feeling better. The information on the batch number has been requested. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect TRUMENBA contributed to the development of the reported events.
N93.9 - Abnormal uterine and vaginal bleeding, unspecified.
However at 2pm symptoms came back as before along with chest tightness and hives.; However at 2pm symptoms came back as before along with chest tightness and hives.; after 5 mins felt tightness in my throat; felt skin tightness; followed by itchy face, eyes and stomach; developed a cough; This is a spontaneous report from a contactable consumer.     A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation.  Medical history included arthritis reactive from Aug2020 , thyroid cancer from Aug2020. Concomitant medications included lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; etodolac (ETODOLAC) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELECOXIB) taken for an unspecified indication, start and stop date were not reported.  The patient  after 5 mins felt tightness in her throat, felt skin tightness,  followed by itchy face, eyes and stomach, developed a cough  on 19Mar2021 with outcome of recovering , however at 2pm symptoms came back as before along with chest tightness and hives on 19Mar2021 14:00 with outcome of recovering.  All the reported events were considered serious because Impotant Medical Events.  Course of the event. Adverse event: after 5 mins felt tightness in the throat, then felt skin tightness, followed by itchy face, eyes and stomach, and developed a cough. At 1200 the patient  was given 25mg of Benadryl, and then another dose at 12:30. This improved symptoms and the patient  was starting to consider going home. However at 2pm symptoms came back as before along with chest tightness and hives. she was given another 25mg of Beandryl and an ambulance was called. In the hospital they gave  epinephrine, famotidine and methylprednisolone, which helped almost immediately. After a few hours she was discharged home.  Follow up information has been requested. Lot number already obtained.
This spontaneous report was received from literature: DELAYED DIAGNOSIS OF HISTOPLASMOSIS IN A PATIENT WITH A PROSTHETIC AORTIC VALVE. JACC. 2022 MAR 08; 79/9 Supplement A. This report concerned a 50 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: congenital aortic valve disease (The patient had post bioprosthetic AV replacement (AVR) in 2014). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, post vaccination the patient was presented with 6 months of flu-like illness, pancytopenia, and suspected transient ischemic attack. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Negative. From detailed workup laboratory investigations revealed myelodysplastic syndrome and positive urine histoplasmosis antigen. Chest computed tomographic angiography (CTA) provided demonstrated a 16x16 mm left lower lobe pulmonary nodule with central cavitation suspicious for pulmonary histoplasmosis. Transesophageal echocardiography (TEE) showed bulky thickening of the prosthetic leaflets with suspected vegetation causing severe prosthetic aortic stenosis. Head and neck CTA showed no mycotic aneurysms. Intraoperative findings included a very large vegetation with near-total obstruction of the aortic valve and circumferential necrotic tissue of the aortic root. Treatment medications (dates unspecified) included: Amphotericin B and underwent redo AV replacement. The authors concluded that despite its rare incidence, histoplasmosis should remain on the differential for infective endocarditis in patients presenting with systemic illness and prosthetic valves. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the histoplasmosis, myelodysplastic syndrome, suspected transient ischemic attack and infective endocarditis with histoplasmosis was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0:20220409335-Covid-19 vaccine ad26.cov2.s-Myelodysplastic syndrome, Suspected transient ischemic attack. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220409335-Covid-19 vaccine ad26.cov2.s-Histoplasmosis, Infective endocarditis with histoplasmosis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE (Myelodysplastic syndrome). Therefore, this event(s) is considered not related.
I experienced injection site soreness, fever, chills, body aches, fatigue, and general flu like symptoms. These symptoms lasted for just over 48 hours.
after being vaccinated patient became faint upon walking to the observation area. Patient was assessed and presented with vitals as follows (82/41, 66bpm, 16rr, 99% RA, 97.8 temp). Patient stated that this is a normal situation for him due to his fear of needles. patient also stated that he had not eaten today and only drank one bottle of water this morning and was feeling weak and hungry. Writer pushed fluids including 2 bottles of alkaline water and a Gatorade. the patient's BP had risen over the course of 30 min as follows 102/64, 107/60, 110/69. Patient stated that he felt better and just needed to eat. Patient has no underlying conditions per patient.
eyes burning/watery noticeable to others; nose runny, coughing, hoarseness; sudden onset; felt as if throat was closing; later felt feverish, had chills; temp not taken; tongue swelled, lips-tongue sore;
Lymph node in armpit very large, swollen, and extremely painful.  Left arm has poor circulation. Fluid backed up into my lower neck.  Took Benedryl.  The next day swelling is down a bit, but armpit is still very painful and my throat is a bit scratchy.
Raised red rash around injection site, severe pruritus.  Attempted to use oral diphenhydramine and topical hydrocortisone to alleviate pruritus with minimal effect.  Symptoms alleviated after ~4 days. Patient said she was getting ready to seek medical attention if symptoms did not alleviate.
Patient received a flu and pneumonia vaccine together. 2 days later, had a fever up to 102 degrees, a couple of days later, fever persisted, rash developed and went to ER. Diagnosed with a staph infection.
Information has been received from a physician concerning a 21-month-old patient who in March 2005, was vaccinated subcutaneously with a 0.5 ml dose of Varivax. On 29-DEC-2006, the patient experienced mild chicken pox. The patient presented with attenuated macules bulle. some of which were scabbed over. Lesions were two to four inches in diameter at maximum. Also noted were areas of hyperpigmentation and dry skin. After these resolved, some areas became hypopigmented. The reporter noted that 20% of the papules became vesicles and scabs; and concluded that if this was a case of chickenpox, it was very mild. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. The outcome of the time of this report was recovering. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
A report was received from a health care professional on 11/7/04, concerning a 47 year old female vaccinee who experienced lymphadenopathy, malaise and a feeling of warmth, 18 hours following the inadvertent administration of expired Fluvirin vaccine on 11/3/03. On 11/5/03, the vaccinee experienced lymphadenopathy, malaise and a feeling of warmth. A description on the clinical symptoms given included swollen and tender lymph nodes behind the ear, under the clavicle, on the left side of the neck and in the vaccinee's left hip. The vaccinee also had constitutional symptoms of malaise and a feeling of warmth. The reporter thinks the vaccinee's symptoms have worsened slightly. An ER physician examined her and stated she was OK. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/23/2003: A follow up report was received from a health care professional indicating that the vaccinee had developed the following adverse experiences on 11/5/2003: Lymph node swelling and left neck swelling that had not resolved at the time of the follow up report. Left arm swelling and pain which were slowly resolving at the time of the follow up report. Left arm pain and left hip pain, which had both resolved at the time of the follow up report. An ER physician checked the vaccinee and said he wasn't sure but felt it probably was due to the influenza vaccine. Update 2, 02/03/04: A follow up report was received from a health care professional indicating that the vaccinee's left lymphadenopathy subsided total on 01/20/04. The reporter reported that the vaccinee has not experienced any further sequelae. No follow up pending, all information received.
Initial case report received from a pharmacist via MedCom on 20 OCT 2009. A 58-year-old female patient, was vaccinated with FLUVIRIN (batch no. 97841P1) i.m. into the deltoid on 24 SEP 2009. On 20 OCT 2009 the patient told the reporter that since her vaccination she had pain and soreness radiating from the injection site throughout her deltoid and biceps. In addition the patient complained of a "heaviness" in the arm into which FLUVIRIN was injected. How soon after vaccination the symptoms began was not known by the reporter. No medical treatment has been sought. Whether the patient self-treated her symptoms was not known by the pharmacist. The described symptoms were not recovered at the time of the report. Reference no. NA09-006649. This case was reported as MA2009-3173. Follow up report received from a pharmacist on 22 Feb 2010: The patient had called the pharmacy and reported that the pain in her arm had slightly improved, but it was still present. Follow up report received on 09 Apr 2010: The reporter had been tried to contact (twice), without any response so far. Thus no further information is expected and this case is considered closed.
Patient inadvertently received vaccine after published expiration date. Moderna analyzed lot 031L20A and advised vaccine maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Immediate sore arm that I could hardly move. Was hot to the touch for days then the raised welted rash that is red and warm to the touch
44 year old female, with no pertinent medical history, who on 02/16/1995 was vaccinated with a first 10 mcg, intramuscular dose in the outer arm of hepatitis B virus vaccine.  It was noted that the vaccination series was completed elsewhere.  The reporter stated that not right away, but within the last couple of years, in approximately 2003 the patient experienced headaches, dizzy spells and some numbness.  It was reported that the diagnosis was unknown.  It was noted that the patient is still being treated.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Severe arm pain starting 12 hrs after injection. Unable to abduct shoulder. No tenderness or swelling.
Presented with weakness, nausea, epigastric pain, cough for about the last 10 days. COVID-19+ but asymptomatic
Started to ached around 9:30 at night. My skin hurt. I had chills, 101.3 temperature, shaking because I was so cold. Aching everywhere. Bad headache. Last most of the night. Feeling much better at 7:00 a.m. the next day.
Bleeding; it's hurt to touch but it itches; it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple; it's hurt to touch but it itches/it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 20Jan2022 (Batch/Lot number: unknown) 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:1st, Pfizer shot), administration date: 2021, for COVID-19 immunization; Bnt162b2 (Dose: 2nd, Pfizer shot), administration date: 2021, for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset Jan2022, outcome "unknown", described as "Bleeding"; VACCINATION SITE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "it's hurt to touch but it itches"; VACCINATION SITE SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple"; VACCINATION SITE PRURITUS (non-serious) with onset Jan2022, outcome "unknown", described as "it's hurt to touch but it itches/it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple". The patient had first two Pfizer shots last spring and then received the booster on Thursday the 20th and that got it was like a golf ball afterwards and then it seems like that spread out and then in middle of it was all purple, It was bleeding to before I took the bandage off but it didn't, means it's hurt to touch but it itches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had expected flu like symptoms shortly after receiving booster.  Then had another low grade fever about a week later, followed shortly thereafter by herpes zoster rash
I had vaccination on 09/28/2022. 07/2022 I fell and broke my right ankle. I was off my foot till about 10/2022. In 12/2022 I started noticing my hip was aching at night more than usual. I attributed this to my body realigning itself as I was getting off the cane for walking. The left hip aches when I lie down and a tender spot. I did have X-rays on 03/17/2023. I have an appointment on 04/03/2023 to find out the results.
Caller states that she got home and felt so cold; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 01Mar2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that received the first dose of the Covid vaccine yesterday and reports that she felt fine, took Tylenol and was working after the shot. Caller states that she got home and felt so cold on Mar2021. Patient reported that when she went to go to bed, she could not explain. The outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever, pain and redness at injection site with 2 'mounds' of swelling that are very firm to the touch.  Slight itching.  By 10/16/2016, fever had elevated, swelling and pain was more severe with pain and swelling past the elbow to the forearm, the armpit, and down the left side.  Redness also continued with blister-like forms in swollen area.
patient took the Moderna vaccine on Thursday and started having a small rash about 3-4 days later that went generalized over body hands feet neck back stomach groin, reports she started with a small rash and took a dose of steroid and rash worsened to all over.
his allergies "fired up" today; Runny Nose; Watery Eyes; This is a spontaneous report from a Pfizer sponsored program COVAX US support (CEP:159558) by a contactable consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8736, Expiry Date: unknown), via an unspecified route of administration in left arm on 12May2021 at 14:00 (at the age of 26-years-old) as dose 1, single for COVID-19 immunization at public health department. The patient's medical history included allergies from an unknown to ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Family medical history relevant to events was none. Concomitant medication was not reported. Additional vaccines administered on same date of the Pfizer suspect was none. Prior vaccinations within 4 weeks and events following prior vaccinations were none. The patient received his Pfizer covid vaccine yesterday and his allergies fired up today (13May2021). On 13May2021, the patient experienced runny nose and watery eyes; however, during this season, he usually gets that. He already has allergies this time of year, it was nothing new. Caller confirms that the runny nose and watery eyes started after receiving the COVID vaccine. Any events did not require a visit to emergency room and physician office. Relevant tests were none. The clinical outcome of events runny nose' and watery eyes' was not recovered, while the outcome of the remaining vent was unknown.  No follow-up attempts are needed. No further information was expected.
Information has been received from a physician concerning a 14 year old male who on 11-JUL-1998 was vaccinated with the first dose of MMR II (lot number not reported), on 05-MAR-1999 was vaccinated with the second dose of MMR II (HSA) (lot number not reported). On 16-NOV-2009 the patient experienced onset of symptoms.  On 18-NOV-2009, the patient diagnosed with mumps. On 18-NOV-2009, laboratory data revealed that IgM <1:10, IgG 7.06 and serum amylase 246. The patient was afebrile and had right parotitis. On 18-NOV-2009, the patient was vaccinated with (rHA) (lot number 664886/0776Y). At the time of the report, the patient's status was not reported. No further information is available.
Resident became chilled, unable to get warm, shivering, unable to get up, oxygen saturation dropped to 50% with heart rate of 133. Tachypnea
Developed a pain at the injection site the next day. Manageable - Scale of 3 out of 10  After 24 hours or so, started developing minor rashes. Today (May 7th), the rashes are spreading across the body. Will see how it develops over the day and then call the doctors office.
This spontaneous case report was received from a registered nurse who heard from an unspecified nurse regarding a patient of unknown age and gender. No concurrent conditions and medical history was reported. On an unknown date (reported as years ago), the patient was vaccinated with PROQUAD injection (dosing regimen, frequency, strength and route unknown). Concomitant medications of the patient were unknown. On an unknown date, unspecified time after being vaccinated with PROQUAD, the patient experienced seizure and had to be air-lifted to the hospital. The outcome of the seizure was unknown. The causality assessment was unknown. No product quality complaint was reported. Upon internal review, the event seizure was considered to be medically significant. The reporter considered the event to be immediately life threatening. Additional information has been requested.
Fever of 101.5 Headache  Pain at injection site Body aches Chills, extreme fatigue
pneumonia; chest pain; SOB; been ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer.), for Covid-19 immunization. The following information was reported: PNEUMONIA (hospitalization, medically significant), outcome "not recovered"; CHEST PAIN (hospitalization), outcome "not recovered"; DYSPNOEA (hospitalization), outcome "not recovered", described as "SOB"; ILLNESS (non-serious), outcome "not recovered", described as "been ill".  Clinical course: It was reported that, Pfizer booster been I'll since 1 month sob 3 days later with chest pain 3 weeks later sob chest pain hospitalized with pneumonia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient described feeling throat becoming very dry a couple minutes after the vaccine.  Patient was given water and then brought back to OBVs 1 at 1531. First set of vitals was taken at 1533, VS were: HR: 80, BP: 142/77, SPO2: 96. Patient was the given more water saying throat was still dry, but not as bad. Patient claimed it was probably the anxiety of after-effects of the vaccine. Second set of vitals were taken at 1543, VS were: HR: 74, BP: 135/75, SPO2: 99.  Continued to talk to the patient and she felt her throat was feeling better and that she felt less anxious after calming down a bit. Last set of vitals were taken at 1552, VS were: HR: 77, BP: 138/64, SPO2: 100. Patient was asked if she felt okay to leave and said yes. Patient was released at 1554 and drove by herself.
The patient states that immediately after vaccination she experienced significant pain in her left arm that still persists weeks after receiving the vaccine. She states that she has soreness in the left arm and it is painful to raise her arm to take off her shirt. It's painful to brush her hair and she is unable to sleep on her left side.  She states that she has never had this type of reaction before. The patient did note that when she was receiving the vaccine she noted that the placement for the vaccine was "up high" near her shoulder.