chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 71-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 19Mar2021 at 14:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included Gastroesophageal reflux disease and cholesterol on an unspecified date. Allergies to medication included azithromycin (ZITHROMAX) on an unspecified date. Concomitant medications included Ranitidine (MANUFACTURER UNKNOWN) and Statins (MANUFACTURER UNKNOWN) for cholesterol on an unspecified. Patient previously received first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203) in the right arm on 26Feb2021 (at the age of 71-years-old) as a single dose for Covid-19 immunisation. (The patient received other vaccines within 4 weeks prior to the COVID vaccine). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced headache and fatigue on 20Mar2021. The patient did not receive 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 headache and fatigue was resolved.    No follow-up attempts possible. No further information expected
I have a bald spot, size of dime, in the top of my head.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female consumer (Patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration in left arm on 9Mar2021 07:00 PM at single dose for COVID-19 prevention.The medical history included Penicillin allergy. concomitant medications were not reported. The patient had a bald spot, size of dime, in the top of my head on 28Mar2021 at 10:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Chills, fever,  shoulder pain in both shoulders,  neck pain,  headache,  severe  fatigue
COLD CHILLS ACROSS SHOULDERS AND DOWN ARMS HOT FLASHES INTENCE JERKING AND SHAKEING UNCONTROLLABLE. SHAKEING OVER WHOLE BODY COLD CHILLS AND VOMITING COULD NOT WALK OR CONTROL ANYTHING
Started with mild headache which progressed over the weekend to severe aches across head, neck and shoulders. Fever 100 - 101 F. She also complained of diarrhea for 3 days approximately six stools per day.
Immediately after the shot I got dizzy and got a headache and abdominal cramps. 30 minutes later the headache was worse, abdominal cramping worsened & turned to severe diarrhea every 20 min for the rest of the day and all night. Fever was 102.5 within hours of getting shot, 101 within an hour. Woke with raging headache, arm very swollen with redness from site to under arm with enlarged nodes. Fever still 102.5, GI upset continued. Called dr, told me to go to ER for pain shot but didnt think related to vaccine! Told to rest, drink fluids (everything I drank went right through me- I couldnt replace them as fast as they were getting lost) and take NSAIDS, ice arm. I got shot right after my monthly IV Igg infusion, very important to increase fluids afterwards, and I was losing so much, kidneys felt incredible pressure/pain and urinated blood twice. Muscle pains worse, felt horrible. Next day fever down to 101 but still with GI upset tho improved and raging headache, fatigue. Called dr who said continue fluids, rest, nsaids, no test or treatment avail unless i wanted to go to ER for IV fluids, but i had  no ride. Today is the 17th and I still awoke with raging headache and fatigue. Will call my dr re: anything else i can do.
Started w/redness and swelling on Tues 4-17-18. Left leg outer thigh has an area of erythema approx slightly warm to touch. 4 cm x 2 1/2 cm: slightly swollen, no induration.
I approx. 3-4wks.   After my 2nd shot I started having flu type symptoms throat was affected lost voice for about 2 mths. Couldn't say a word I gradually started having difficulty breathing  something showed up in my right lung that wasnt there before was put on various meds to help me breath antibiotics  several courses and to this day I cant breath too well  just walking 12 ft leaves me out of breath
This case was reported by a nurse and described the occurrence of an injection site reaction in an 5 year old male pt who received DTAP (Infanrix) for prophylaxis. On 07/22/03 the pt received the 4th dose of Infanrix (Lot # DTPA592B9) in the left arm.  On the same date he also received an injection of IPV. On 07/23/03, 1 day post-immunization, the parents noticed that the pt had developed an injection site reaction characterized by a  "large" area of redness and swelling at the site of Infanrix administration. The parents administered Tylenol and applied ice to the area. The pt was seen by the physician. The event resolved after an unspecified period of time. The reporter considered the event to be unrelated to vaccination with Infanrix.
Swollen and painful lymph nodes in left arm pit beginning 6 days after the injection.
Vaccinated with 2 mo. series at 2 mo. WCC on 1/20/12. Woke up Sat 1/21/12 screaming, spitting up...bowel changes...this continues. He came to office today...some improvement. Will monitor. May treat with PREVACID...
Pt. states that after receiving the 2nd dose of Moderna 07/26/2021, started experiencing symptoms immediately of flu-like symptoms, achy, and severe chest pains. Urgent Care visit 07/27/2021, Chest X-Rays, EKG. Recommendations for Follow-Up with Specialist. No noted appt. Symptoms have subsided.
Breakthrough case admission after three vaccines Moderna 2/5/21 Lot# 010M20A;  Moderna 3/6/21 Lot# 027L20A;  Moderna 6/2/22 Lot# 058A22-2A
First dose in left arm.  Following morning pain under the left arm.  Major swelling of the left breast.  Skin taut.  Swelling under the arm.  Difficult to place left arm at side due to fullness under the arm.  Could not wear undergarment. Swelling spilling over. Had to use ice packs under the arm at night.  Burning/chaffing sensation yet skin not red.  No hard lumps.  Squishy. Much fluid accumulated.  Continued down the side of the left rib cage.  Eventually, within a week, the fluid sacs began to fall down the left side of the rib cage and eventually reabsorbed.   HOWEVER...second vaccine received 3 weeks later in right arm at same facility on 4/15/21..  Next morning  can't raise right arm due to severe pain under the arm/armpit area.  Obvious swelling of a lymph node that projects outwards, under the arm and is hard and sore.  There is swelling in the right breast but not as significant as the first shot on the left side.  Cannot place arm at side as there is again fullness under the arm and much discomfort.  Same chaffing/burning sensation under the arm.  After both vaccines could not wear a bra due to the discomfort in the band area specifically under the arm.  It has been over 3 months and still having issues on right side.
Information has been received from a registered nurse and physician concerning a white male who was vaccinated with a first, second and third dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) IM dates not reported.  The patient "came down with the mumps".  The reporter also reported the patients brother's experience (WAES # 0210USA02068).  Unspecified medical attention was sought.  No further information is expected.
gave an ActHIB injection to a 16 month old female that was reconstituted with sterile water instead of 0.4% Sodium Chloride/ No AE; Initial information received on 08-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 months old female patient who received 0.5 mL dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UI918AA, Expiry date- 05-12-2019 via intramuscular route in right Antereolateral On 07-May-2019, that was reconstituted with sterile water instead of 0.4% sodium chloride.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was a case of actual medication error due to Wrong solution used in drug reconstitution .  No AE Reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
I tested positive for Covid 19 on August 29,2022 I experienced Fatigue, Fever of 102.0, muscle aches, sneezing, cough. I was taking Tylenol and was prescribed Paxlovid for my symptoms.
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-004181, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004186, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Made me sicker than the flu ever has.  I threw up for 3 days, then it took me another week to get anywhere near back to normal. I was weak, dizzy, couldn't stand up and could hardly eat.  My arm swelled and turned very red and hot from the shot.
Double vision and slurred speech, tentative diagnosis of Miller Fisher Guillain Barre by a neurologist.  12/08/09, 12/11/09, and 12/14/09,  Hospital records received. Service dates 12/06/09 to 12//11/09. Assessment: Miller Fisher varient of Guillain-Barre Syndrome. Elevated blood pressure. Patient presents with dysphonic nasal speech and upper body weakness of 3 days duration. Diplopia, right gaze, bilateral cranial nerve VI global weakness. Dysphagia. Paresthesias fingertips. Recent URI progressing to bronchitis. Sore throat. Decreased active range of motion secondary to weakness. Decreased tendon reflexes. Tissue texture changes mid left thoracic paraspinal muscles. IVIG administration. Headache. Hypertension. Candida tongue. Mild renal impairment.  12/28/09 Discharge Summary received. Service dates 12/6/09 to 12/11/09. Assessment: Guillain-Barre Syndrome, Miller-Fisher varient. Hypertension. Additional information abstracted: Laryngitis progressing to bronchitis. Toe swelling. Stable condition upon discharge.  1/4/09 Hospital records received. Service dates 12/6/09 to 12/15/09. Assessment: Miller Fisher varient of Guillain-Barre Syndrome. Elevated blood pressure. IVIG administration. Patient c/o suboccipital and frontal headaches. Oral candida. Migraine.
Pt stated he had chill, body aches, headache, and felt like he had the flu.  He also said he had tachycardia.
RN rpt pt recv 1st dose varivax & same day 3rd dose of dtp 12/4/96 & in 5/98 pt devel breakthrough chickenpox w/multiple 1/4 to 2 cm erythematous, itchy spots. MD attn sought & treated w/meds
Narrative:  Patient received COVID Moderna vaccine # 1 on 8/10/2021. A note was entered on 9/10/21 to say that the patient was in the hospital, but no further notes after that. No scanned records from that hospitalization are available either. A date of death was recorded as 9/19/21. There were 40 days from vaccine #1 to date of death. Symptoms:  & death Treatment:
I woke up the next day with a golf ball sized lump behind my knee. I went back to the doctor and they diagnosed it as a bakers cyst. They did a ultra sound on it. 2 months later, they were going to do an MRI, but the day that the MRI was scheduled, I woke up that morning and the lump was completely gone from my knee and it had moved to the right side of my neck. 2 days later, it was so big that it cut my air passage off. If I didn't have a CPAP machine to force air into my lungs, I wouldn't be writing this today. I spent 3 days in ICU at Hospital. And of course they said that I had a lymphoid gland swelled.
Blood clots; Congestive heart failure; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An 83-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots"; CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "Congestive heart failure". Clinical Course: Nurse described to me that her 83-year-old father developed blood clots after receiving the COVID vaccine in early 2022. She wasn't sure which vaccine he received but she was certain it was a result of the vaccine. The nurse also described other conditions that developed after receiving the COVID vaccine. She mentioned congestive heart failure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events Thrombosis,congestive heart failure and the suspect drug cannot be excluded.  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.
Agitation, Headache, Sedation, Myalgia, Arthralgia, Sunburn sensation across shoulders, fatigue, insomnia, local knot. Narrative:  Got vaccine #2 on Thurs 14th@ 10:00 Two hrs after got brain fog, difficulty focusing, delay between thinking and talking. Fatigue in afternoon, Aching and fever at bedtime, than anxiety, restless & fidgety kept her from sleeping. Headache, body aches. Friday bad all day until 2100-2200, then improved. Sunday mild relapse. About same as Monday. Lump at site. Not in axilla, Burning pain across shoulders (same as site for #1) like a bad sunburn.
Two days post having received the vaccine the patient experienced dizziness, shortness of breath, palpitations, and chest pain.  He wore a heart monitor that revealed his heart rate would drop to 38 beats per minute.  There were no pathologic arrhythmias noted otherwise.    All blood work was within normal limits.
having lymph node pain right under the arm on the side he got the shot/it is painful and sore; This is a spontaneous report from two contactable consumers (one of which was the patient's sister) reported that a 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the arm on 02Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was experiencing lymph node pain after 10 days (12Jan2021) just under the armpit area (also reported as under the arm on the side he got the shot) bilaterally that radiates down his sides. The patient stated that it was painful and sore. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Arm became very sore, but not the usual soreness from past flu shots, within two hours.  The first injection given malfunctioned so the nurse repeated it a bit higher on the arm.  The shoulder was very sore and it radiated down the arm to the elbow.
Starting the day after booster, had shortness of breath and heart palpitations, as well as acute pain in left lymph node under arm and on left side of left breast. Spent the day on the couch. Next day moving around symptoms more noticeable. Could not walk across a room without shortness of breath and heart palpitations. Skipped beats, extra beats.
SECOND DOSE OF JYNNEOS WAS ADMINISTERED ON DAY 18 INSTEAD ON DAY 28 (INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
Apparent COVID Arm:  Large red blotchy patch (3 inches in diameter) at the site of the injection that appeared approximately 9 days after first dose shot.  Extremely itchy!! Applied cortisone ointment to the area 2-3 times a day for approximately 3 days. Saw personal physician on 2/16/21 to discuss my reaction and to confirm that there was no need for concern and it would be safe to receive my second dose. As of this reporting, my arm has cleared up completely and I am no longer experiencing any itch or pain. At the time of the injection, I experienced pain as the vaccine was being administered and subsequently a very painful arm for approximately a week and a half.
Localized rash to right thigh where MMR was given, treated with BENADRYL.
receiving expired vaccine/several patients received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired vaccine/several patients received expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired vaccine/several patients received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired vaccine/several patients received expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Health care professional (HCP) mentioned that several patients received expired vaccine and wanted to know how to manage those patients to revaccinate them.  Treatment information was not reported.
pt recvd vax 23DEC94 & t103-104 p/vax; given tempra; p/3 days pt broke out w/rash;
November 25th, I developed sever dizziness. It felt like the room was spinning around me and I was unable to walk. A trip to the Emergency Room and I was diagnosed with vertigo. Further investigation by my primary care, ENT, and PT revealed it is not BPPV, but actually vestibular neuritis. I was exposed to something which irritated my nerves and caused severe inflammation. Further testing revealed a 40% loss of function on my left side affecting balance, eye movement, and tracking. Further vestibular therapy and neurology consults are recommended.
5APR 830PM convuls (sz); t102, leg swollen @ site of inject;
she started to have pain post FLu vaccine 3 weeks ago,   no swelling , but it was very sore from the beginning.  at the moment she is keeping her arm / shoulder quiet , she is afraid to use it  tender on the upper arm, no pain over AC joint, decreased range of motion.
PAtient stated she is having back pains and was having trouble breathing for a couple of days Pt received Azithromycin 250mg pak for Dr  and is pending several tests
Pt reports difficulty breathing that lasted apprx 2hrs.  Pt did not reports the adverse event until the day after the AE occurred.
pt had a positive COVID test on 9/10/21 from Hospital; pt to ED at other Hospital on 9/13/21 with progressive SOB, cough, congestion, fever, chills; NRB; rapid COVID test positive; CXR shows viral pneumonia; given IV ABX and Dexamethasone; experienced PEA; ACLS; intubated; pt's condition worsened; on 100% ventilation; transitioned to comfort care; pt expired in the hospital
Patient was given Pfizer 5-11 vaccine dose.  No adverse events known to have resulted.
COVID-19th case. Sneezing uncontrollably and felt off, not terrible and had a lot of coughing. Those were the initial symptoms. Over the days it moved slightly into my chest and I could feel something building up in my lungs. 9 days after the first symptoms I went to see the doctor. He heard the rattling sound in my chest and prescribed 4 days of steroids and antibiotics. I've finished both and things are much more back to normal now.
4 month shots - 1 day after hives develped. Given Atarax. Enfamil lilpil 3 months. At 12pm was feeding, tried enfamil with iron. Broke out again.
Information has been received from a licensed practical nurse concerning a 24 month old male patient who on approximately 13-AUG-2009 was vaccinated inadvertently with 0.5 ml of a dose of GARDASIL (Lot: 660612/0229X) I.M. instead of a dose of hepatitis A vaccine (inactive) (manufacturer unspecified) by human error. There was no adverse event reported. Additional information has been requested.
felt under the weather for 12-15 hours; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient of an unspecified age (reported as patient's age: above 65; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "felt under the weather for 12-15 hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.