chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented for second Pfizer covid vaccination today.  She tolerated first vaccination well, however did note some hives on trunk 1 week later, which resolved with zyrtec.  However, did have some residual erythema on chest at presentation today.    I met with her before vaccination and given CDC recommendation to only discontinue vaccination series if evidence of allergic reaction within first 4 hours of vaccination, and patients motivation to complete series, we did proceed with second vaccination.   Approximately 10 minutes after vaccination (11:30 am), she reported feeling hot and tingling in extremities and tongue.  She did not feel short of breath, was able to drink water, but did report mild tightness of throat.   Initial PE:   She had increased erythema on chest, no redness or edema noted of face or tongue. No acute distress/increased work of breathing.  Mild tachycardia, regular rhythm, lungs CTA bilaterally.  Skin warm and dry, conversant and alert.    Vitals initially HR 91, BP 121/85, O2 99%. Temp 97.2 F O2 sats remained 96-100 at all times.  After 5 minutes, pt given 50 mg IM benedryl.  Discussed having husband meet her to drive her home and to be with her this afternoon in case of worsening symptoms.    After 15 minutes, BP 11/5/72, HR70 and O2 100%.  She did begin to feel sleepy, but was able to ambulate to bathroom with assistance without difficulty.    She felt her symptoms had resolved after 30 minutes and felt comfortable returning home with husband.  She will continue benedryl 50 mg q 4-6 hrs for 24 hrs and allegra, which she had added recently for hives.    They have strict instructions to seek medical attention with any change in condition.  I will follow up with her tomorrow as well and then will also report to VAERS.     4/21/21 1:30 pm I spoke with Patient- she is doing very well today.  She states she took an additional dose of benedryl before bed and allegra.  This morning complete resolution, however where she had some hives in the last two weeks have flared and are itchy.  I have asked her to sign up for vsafe and I will submit to VAERS as well.  I also suggested she consider seeing an allergist if she has ongoing issue with hives.
After providing the Moderna vaccine, patient passed out going forward in slow motion and head was resting on table, then immediately started seizure-like action putting him in an upright position and I put my arms out to keep him from going forward and then he opened his eyes and came to. After talking to him while in observation, he mentioned that it felt like he was out for 5 minutes even though it only lasted for about 10-15 seconds. He mentioned that 12 years ago this happened (someone had thrown a rock and it hit his hand and when the nurse went to clean it, he went cold and when he came to it was exactly how it was after getting the vaccine). He only recalls feeling cold. When patient was about to leave, I suggested to him to reach out to his PCP to see if it's ok to give his 2nd dose with us or if he should be observed in a clinic setting. I did a follow up call a few hours later and he is doing fine.
This spontaneous report was posted somewhere on social media and was received from a registered nurse via a company representative concerning a multiple unspecified female patients of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with some unspecified doses of GARDASIL 9 and GARDASIL (concentration, frequency, route and lot number were not provided) for prophylaxis. On an unknown date, after the administration of the vaccines, the multiple unspecified patients developed ovarian failure and infertility. The outcome of ovarian failure and infertility was unknown. The causal relationship between adverse events and therapies were not provided.
Information has been received from a consumer concerning his son, an 11 year old male patient. The patient had not any pertinent medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications reported. On an unknown date, the patient was vaccinated with VARIVAX intramuscularly (dose number, dose, anatomical location, lot number and expiration date were not provided) for prevention of chicken pox. On 13-FEB-2017, the patient experienced chickenpox. The patient did not seek medical attention or received any treatment for the event. At the time of report, the patient had not recovered from chickenpox. The relatedness between the chickenpox and VARIVAX was not provided. There was no product quality complaint involved. Additional information has been requested.
Pt vaccinated with MMR developed cochlear apodlexy lt ear; ringing sensation, hearing impairment.
Tiredness, Fever, Severe Headache, Vaccination area swollen red and hot.
4 hours after vaccine, lips and throat be gain to swell. I became lethargic, almost unable to stay awake but managed to ensure I took Solumedrol and Benadryl before falling asleep. When I woke up, the joints on my right side were swollen. The next day, a large amount of hair fell out of my scalp. I had chest pressure and felt exhausted for 2 weeks . The beginning of week 2 (and continuing today) my joints began to hurt and my hand grasp is weaker on both hands. I have lost about half of my hair and remain tired and foggy. Labs pending.
Chills, fever, fatigue, brain fog, muscle aches, joint pain, chest heaviness, headache, cough
On or about August 7th, 2021 woke up with a severe calf cramp.  Never experienced before.  After a few minutes it died down. Calf was sore for a few days, after which it felt like a knot in lower right calf for a few weeks.  On August 20th, 2021 sitting at work desk and back of right knee started aching. Adjusting position didn't work. Unable to easily walk. Went to Urgent Care on August 21st, 2021, they couldn't diagnose blood clot so referred to emergency room.  Ultimately a massive DVT was discovered from mid thigh to calf, pulmonary embolism's and a saddle pulmonary embolism.
Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 11:30 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Patient had no medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included levothyroxine 150 mcg (MANUFACTURER UNKNOWN), colchicine 0.6mg (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 10:00, the patient experienced severe headache four days after first vaccine. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of severe headache and included treatment with ibuprofen 600mg (MANUFACTURER UNKNOWN). The clinical outcome of the event severe headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recv vax 9 or 10AM began persistent & inconsolable crying @ approx 2PM & cried until approx 11PM;went to sleep & was fine the next day;no significant local rxn or inc temp;
dizzy, very bad headache, stiff joints, stiff and painful neck, trouble breathing and short of breath, fever, ligh-headed, tired, whole body sore to the touch--fainting.  felt like I was becoming paralayzed--  was like this for 2 days.       I WILL NOT HAVE THE 3RD DOSE.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient reported about covid treatment. The patient had received vaccine. No other medication in 2 weeks. Anti viral details for COVID 19 Treatment included product brand as Paxlovid on 30Jun2022, (lot number=1910753A) for Treatment of COVID-19 and treatment stopped on 05Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
extremely high fever, runny nose, chills, full-body aches, hard-time breathing, joint aches, swollen lymph nodes, headache
DISCOVERED UNRESPONSIVE WITHOUT PULSE, RESPIRATIONS, HEART BEAT ON 2/7/21 AT 0435 A.M. RESIDENT WAS DNR STATUS.
Arm (upper) turned bright red (right arm) painful to the touch lasted about 72 hrs. Took ibuprofen and Benadryl.
After receiving the flu vaccination the patient reported severe arm pain.  The pain has not resolved sufficiently so the patient has consulted with her physician who wants to perform x-ray and MRI to determine why the pain has not fully resolved itself
A report has been received from a Health Professional concerning a 9 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 11-Oct-2013. It was reported that the patient received only half dose of FLUMIST which started on 11-Oct-2013. FLUMIST was discontinued on 11-Oct-2013. The outcome of the event of patient received only half dose of FLUMIST is unknown. The report was considered to be non-serious.
Adult dose given to child.  No immediate adverse effect.  Arm without swelling or tenderness. No noted systemic effect after 30 minutes.  Parent given specific instructions on reporting and treatment of any local and systemic effects including contact numbers of health department
Patient describes a small red bump about 1 in in diameter, not painful, slightly itchy.
positive of COVID-19; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for himself that. A male patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: Formulation and Lot number: unknown), via an unspecified route of  administration on 12Mar2021 at a single dose for COVID 19 Immunization. Medical history and concomitant medications were not reported. since the vaccination  patient had tested positive of COVID-19. He is asking if he can still get the 2nd dose of the vaccine which is scheduled on 02APR21. He refused to be transfer due to a long queue and created manual AE form.   Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information? No  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse (RN) concerning a 17-week-old male who on 02-MAY-2005 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought and no symptoms were reported. Additional information has been requested.
Extreme fatigue; muscle pain 10 days after vaccine.; Abnormal postmenopausal uterine bleeding nine days after both first and second vaccine shot.; This is a spontaneous report from a contactable consumer (the patient). A 53-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number ER8737), via an unspecified route of administration in the right arm on 08Apr2021 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen. The patient previously took and had allergies to metronidazole. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the right arm on 18Mar2021 12:00 as a single dose for COVID-19 immunization and experienced abnormal postmenopausal uterine bleeding nine days after the dose. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced abnormal postmenopausal uterine bleeding nine days after both the first and second vaccine shot, on 17Apr2021 (reported as on 16Apr2021). Extreme fatigue and muscle pain 10 days after vaccine on 18Apr2021 (also reported as 16Apr2021). No treatment was received for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Initial report received on 19 November 2009 from a company representative, who obtained a lay press article dated 17 November 2009 via Internet site. A handful of academy students (females) were taken to a medical center after receiving either swine flu injections or nasal spray vaccination at a school the morning of 16 November 2009. The trade names, manufacturer names, lot numbers, routes and sites of administration were not reported. One patient reported feeling lightheaded, one had a stomachache, and one reported a rash. It was not clear if the symptoms reported by the students were due to the flu vaccinations or not. By 14:00 pm, all but one of the girls had been released from the hospital. One girl, who suffered from asthma, was held a little longer for chest X-rays. It was the first known instance of people reporting not feeling well after participating in the statewide H1N1 school vaccinations program, which began Friday (13 November 2009). After immunization, the students were required to rest in the immunization room for 15 minutes before returning to class. It was not believed that lack of rest was to blame for the adverse reactions. It was in this room, while the students were seated, that a lot of the reactions occurred. A couple of teachers and an adult volunteer also reported feeling ill after receiving the immunization. Eight students reported a reaction, and city paramedics were called to the school as a precaution and per policy procedure. The paramedics were sent to the school three times the morning of 16 November 2009. The first call for assistance was received at 9:27 am for a girl younger than 10 years of age who was complaining of shortness of breath. She was taken in stable condition to the hospital. At 10:16 am the same day, paramedics were called back to the school and transported two additional adolescent students who were in stable condition to the hospital. One was complaining of stomach pains and the other of being lightheaded. The third call came at 11:22 am where a woman at the school was taken in stable condition to the hospital for an unknown medical complaint. A second ambulance crew on the third visit took two more girls to a nearby hospital in stable condition. Both girls were complaining of abdominal pain and blurry vision. In addition, paramedics treated and released three adults and another child at the school. Per the article, the health department was quoted as saying "Feelings of anxiety could have transferred from one student to another resulting in the number of students who reported feeling ill after the shot." The recovery status was not reported for any of the patients. Documents held by sender: None.
Information has been received from a consumer concerning their sister's friend who on an unspecified date was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed shingles.  At the time of the report the patient's status was unknown.  There was no product quality complaint involved.  Additional information has been requested.
Pt was given 3 vaccines MENACTRA, TDAP & HEP B.  He was sitting in a chair, his head fell backwards and he began to slide off chair.  With help got him to floor, laid him down.  Regained consciousness within 1 min.  BP 100/60.  Paramedics called.  BP would not come up.  Began c/o chest pain.  Taken to ER.
This spontaneous report as received from a pharmacist refers to a 6 year old patient (gender unknown). Pertinent medical history and drug reactions/allergies were not reported. On 18-OCT-2013, the patient was vaccinated with RECOMBIVAX HB, 1.0 ml (adult dose), intramuscular. Other suspect therapies included VAQTA 1.0 ml (adult dose). Concomitant therapy was not reported. No adverse effect was reported. This is one of two reports from the same reporter. Additional information has been requested.
chills; pain in my jaw/behind the base of my left ear; upset stomach; trouble sleeping; soreness at injection site; pain in my jaw/behind the base of my left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 10:00 (Lot number: FL3209) at the age of 40 years as dose 3 (booster), single for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0182, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 08May2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "No adverse event"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 17Apr2021, when the patient was 39 years old, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: CHILLS (non-serious) with onset 11Jan2022, outcome "unknown", described as "chills"; EAR PAIN (non-serious), PAIN IN JAW (non-serious) all with onset 11Jan2022, outcome "unknown" and all described as "pain in my jaw/behind the base of my left ear"; ABDOMINAL DISCOMFORT (non-serious) with onset 11Jan2022, outcome "unknown", described as "upset stomach"; INSOMNIA (non-serious) with onset 11Jan2022, outcome "unknown", described as "trouble sleeping"; VACCINATION SITE PAIN (non-serious) with onset 11Jan2022, outcome "unknown", described as "soreness at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, ear pain, abdominal discomfort, insomnia, vaccination site pain, pain in jaw.  Additional information: The patient did not receive any other vaccine with in in four weeks of covid-19 vaccine. The patient was not diagnosed with Covid prior vaccination. The patient was tested for Covid post vaccination (iHealth Covid-19 Rapid Antigen Test (Nasal Swab) on 12Jan2022 resulted negative). The patient had no known allergies. The patient had some common Covid vaccine side effects, including chills, upset stomach, trouble sleeping, and soreness at injection site, so those weren't unexpected. But the one that seemed unusual was pain in jaw/behind the base of left ear. This pain was not constant, when it happened it was a stabbing pain that only lasted a moment each time. Sometimes it would happen once, and other times it happened many times in a row, with no pain or aches in between these brief stabbing pains. It was always in the exact same location. It happened off and on throughout the night, and mostly subsided the following day, other than happening a handful of times late the next morning. The patient never had anything like this happen before and was generally very healthy.  No follow-up attempts are possible. No further information is expected.
Significant swelling of injection site, significant swelling of lymph node (under arm) on same side, radiating pain from injection site, swelling of neck/face, difficulty breathing, fever for 48+ hours (101+), all symptoms occurred approximately 12 hours after injection.
pt recv vax & devel rash, gen adenopathy;arthralgia/arthritis;
p/vax pt exp pain @ inj site; 2 days p/vax pt devel a h/a & pain @ the back of the head & neck which were unrelieved w/APAP;the 6th & 7th day post vax & was unable to sleep d/t h/a;seen in ER on 6NOV;see by MD poss inflammation of brain;
I have been on the same birth control for three years, days after my second vaccination I got pregnant. Nothing else in my life has changed or altered that could have caused this. I've always taken my birth control at the same time every single day without EVER missing a dose. I have five children already so I make sure to be a safe as possible. Within a week of getting vaccination I started feeling sick every morning, I took a pregnancy test the Monday following my second dose, and low and behold I'm PREGNANT.  I was encouraged by the dosing nurse at my clinic to report this as I am concerned there is going to be something wrong with this baby. I have been almost unbearably sick since conceiving and that's never happened with any other pregnancy. It takes everything in me just to get out of bed and care for my children. PLEASE ADVISE!!!
Muscle and shoulder really aches with use or sleeping on her left side.  Patient stated she felt slight soreness the day of shot but the soreness has not gone away after 2 weeks. Described as a deep muscle soreness.  No swelling, bruising or heat to touch was reported. Patient stated that there was some slight pain with administration similar to immunizations that she had in the past, nothing out of the ordinary.   Spoke with patient on october 1st and recommended making an appt. with doctor to get checked out. Recommended Ibuprofen for pain until doctor could be seen.  Spoke to patient again on 10/4/19 and she is still having the soreness.  She has made an appt. with her PCP.
It started with swelling and redness in my left arm at the injection site, and burning and heat. I felt fatigued, I went home took tylenol ate dinner and went to bed and at 2 am I woke up and my fever was 102, I had severe muscle aches, horrible headaches, and uncontrollable chills, I took more tylenol and an hour later I took my temp it was 103.5 and the chills were intense and I was shaking horribly, I fely nauseated and I devopled a bit of a cough, My temp remained close to 104. As soon as I woke up that morning it was a sunday so I couldn't get into my normal doctor so I went to the clinic, I got a covid test was negative and I was so sick I don't remember much of the visit. I stareted hullicinating , once my fever was down that stopped.  The nausea was terrible. I missed 3 days of work. By the 4th day my fever was gone and I just still felt very fatigued.
First shot only sore arm , second shot low grade fever, body aches, extreme fatigue about 36 hours
fever 102.6;aching body, cough, weakness, pneumonia; Biaxin x 10 days-still on
patient reporting redness, warness, and difficulty raising arm over head. Called pharmacy to report adverse event. Informed patient needed to seek treatment if does not improve.