chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT STATES FOLLOWING DAY AFTER BOOSTER MODERNA  EXPERIENCED SKIN REDNESS , HEAT, PAIN AND SWELLING ON RIGHT ARM AT SITE OF INJECTION. PATIENT STATES RED AREA GOT LARGER  ON DAY 3 . PATENT WAS WORRIED AND HAD A VIDEO APPOINTMENT WITH DR ON  03/22/21 . DR TOLD PATIENT HE THOUGHT  THERE WAS A POSSIBLE INFECTION AT SITE OF INFECTION PERHAPS CAUSED BY THE COVID VACCINE STORAGE. PATIENT WAS STARTED ON KEFLEX ANTIBIOTIC BY MD .  12/23/21  PATIENT SAYS REDNESS HAS   ALMOST GONE AWAY AND FEELS FINE
L sided chest pain SOB starting on 8/6/21 seen in and ED and dx with pericarditis also followed up with cardiology and started on colchicine then got worse after 2nd covid vacccine on 8/16/21
pt develop a local reaction in the inject site; develop erythema, induration, pain tenderness & swelling in the inject site; t38.4; movement limitation;
Discharge Provider:  DO Primary Care Provider at Discharge: MD Admission Date: 5/7/2022 Discharge Date: 5/11/2022  DISCHARGE DIAGNOSES: 1. Acute hypoxemic respiratory failure due to COVID-19 pneumonia 2. Mild pulmonary fibrosis 3. Type 2 diabetes mellitus 4. Gout 5. GERD with Barrett's esophagus 6. Coronary artery disease s/p CABG 7. Hyperlipidemia  HOSPITAL COURSE: Patient is a 83 y.o. male with past medical history significant for hypertension, coronary artery disease, history CABG, hyperlipidemia, diabetes, mild pulmonary fibrosis, history of prostate cancer, Barrett's esophagus, GERD who was brought into the emergency department via EMS for 5 days of shortness of breath, cough with clear sputum production, decreased appetite, but diarrhea and tiredness. He has been vaccinated and boosted for COVID-19.    Upon arrival to the emergency department, he was satting at mid-upper 80s on room air and required 2 L O2.  He was also febrile.  He was originally thought to be septic-- sepsis workup initiated.  Blood cultures obtained, urine culture ordered.  He was given empiric Rocephin and Zithromax.  COVID test came back positive.  He was given 6 mg of Decadron IV, Tylenol 1000 mg, total of 2.5 L IVF.  Also given an albuterol, DuoNeb.  Chest x-ray shows patchy infiltrates without any lobar consolidation and mid left lung base atelectasis.  EKG showed tachycardia.    Patient was admitted and was given dexamethasone and remdesivir.  Patient's oxygen saturations slowly improved.  Blood cultures done in the emergency room came back positive, but identified as Staph hominis and Staph epidermidis, both of which can be considered contaminants.  Repeat blood cultures have remained negative.   He was markedly improved on day of discharge, 5/11/2022.  He can continue with symptomatic treatment following discharge, including Mucinex 600 mg PO BID and anti-tussives as needed.  He can follow-up with his PCP in 1 week.  He will be followed by the hospital-at-home program, as well as home health care following discharge as well.
Extreme fatigue and headache post first dose about 2 hours after the vaccine  nothing after the second dose
Before vaccination infant was completely healthy with regular bowel movements once every 24-48 hours.  No history of diaper rash.  Infant was also sleeping in intervals of approximately 5 hours during the night.  After vaccines were administered on 6/4/2008 at 9:30am the infant began having diarrhea that afternoon and it has continued without end 8-10 times a day for the last 5 days and has not subsided.  The infant has also developed her first diaper rash that has started to slightly bleed.  The infant now only sleeps in 2 hour increments due to bowel movements (diarrhea).  Infant also has diarrhea every time she eats almost immediately.  Infant does not have a fever.
"Normal" response of soreness at the injection site, eventually fever and nausea and fatigue, then, flared covid neuropathy and cough symptoms
From initial information received on 4/22/04 and additional information received on 4/23/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 20 year old female patient received her third dose of pre-exposure IMOVAX RABIES, lot number unknown, and a first dose of HEPATITIS A VACCINE, lot number 1165M, administered in the left deltoid on 3/24/04. The next day, on 3/25/04, the patient experienced severe abdominal cramps, nausea, and diarrhea, which lasted for five to six days. The patient reportedly recovered from this experience. The physician stated that he did not feel the patient's adverse events were related to the vaccinations. From information received on 5/28/04 from a health professional, it was reported that all information has been received and no additional information is available at this time. No further information is anticipated, this case is considered closed.
Discomfort in left side of neck and shoulder; Swelling on left side of neck clavicle area and just below clavicle up above breast; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration on 27Mar2021 at 10:00 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included diabetes, gastroesophageal reflux disease (GERD), and high blood pressure. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included semaglutide (OZEMPIC), insulin degludec (TRESIBA), insulin lispro (HUMALOG), amlodipine, and loratadine from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN6205) on 02Mar2021 at 10:00 as a single dose in the left arm for COVID-19 immunization. On 27Mar2021 at 10:30 (also reported as 15 minutes after the vaccine) the patient experienced swelling on the left side of the neck clavicle area and just below clavicle up above breast and discomfort in left side of neck and shoulder. The swelling began 15 minutes post vaccination and was accompanied by dizziness only when the neck was leaning to the left. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of swelling on the left side of the neck clavicle area and just below clavicle up above breast, discomfort in left side of neck and shoulder, and dizziness only when the neck was leaning to the left were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
chest pains; chest pains; blood clot; light headedness; low fever; blacked out for about 5 minutes; onset of major body ache and fatigue; onset of major body ache and fatigue; Body aches at injection site and into upper back; Body aches at injection site and into upper back; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 23Feb2021 10:30 AM (at age of 67 years old) as single dose for COVID-19 immunisation. Medical history included high cholesterol. Concomitant medications included atorvastatin; levobunolol (eye drops); latanoprost (LATANO). The patient previously received his first dose of BNT162B2 on 05Feb2021 for COVID-19 immunisation (brand=Pfizer; lot number: EL9269; administration time 03:30 PM; vaccine location=Left arm; dose number=1). 6 hours after injection on 23Feb2021, the patient experienced body aches at injection site and into upper back. After 24 hours after injection on 24Feb2021, started light headedness, low fever, blacked out for about 5 minutes, onset of major body ache and fatigue. Spent the next 36hrs in bed. 72hrs after injection recovered back to normal slowly. On 04Mar2021 at 8pm, started with chest pains called, admitted to Hospital with heart attack, immediately taken to Cardiac Cath Lab for coronary catherization in both legs, to partial remove blood clot and insert continuous balloon pump, IV Heparin infusion Troponin 6542.3 ng/l (critical), NO previous health issues for blood clots. Discharged 07Mar2021, Apixiban 5mg twice a day, Clopidogrel 75 mg /day. AE resulted in: Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event. Number days hospitalization: 3 days. The outcome of events was unknown.
Area of injection site is red and swollen from shoulder down about 8 inches. No fever.
Patient came to the ER on 8/18/2021 with chest pain and shortness of breath, ultimately diagnosed with pericarditis. Patient reports these symptoms started 3 weeks after his second dose of Pfizer COVID vaccine (Lot number unknown, not given at this facility).
I woke up at 2:30 AM to find that my left pinky and ring finger and tingling (sometimes the tingling radiates into my wrist) and I have slight intermittent tremors in the fingers on my left hand.
Vertigo symptom started at 6:30AM in the morning on Nov 8 when I tried to get up. It got worse (vertigo + nauseous) on Nov. 10, and my husband had to drove me to the clinic. I have no ear problem, no flu symptoms. My doctor told me I go labyrinthitis caused by virus. I toke meclizine and stayed on bed for almost one week, I come back to work on Nov. 17, exact 2 weeks after flu vaccination. I still fell light dizzy now.
Information has been received from a registered nurse concerning a 23 year old female with no history of drug reactions or allergies who on 19-JUL-2007 was vaccinated with the first dose of GARDASIL and on 23-JUL-2008 was vaccinated with the second dose of GARDASIL (lot# 660557/0072X) in left upper arm.  Subsequently, on 23-JUL-2008 the patient experienced a sore lump at the injection site of her left upper arm.  The left arm "felt weak" and the patient was unable to lift her child, which caused a significant disability. The patient initially tried a cold compress on the injection site but did not notice any improvement.  On 03-AUG-2008 the patient experienced diarrhea and a stool culture was performed.  On 08-AUG-2008 the patient was diagnosed with Clostridium difficile and was treated with ibuprofen, TYLENOL, hydrocodone and BENTYL.  The patient's sore lump at the injection site and Clostridium difficile diarrhea persisted.  Sore lump at the injection site was considered to be disabling.  The patient sought medical attention with a telephone call.  Additional information has been requested. 10/2/08-records received-visit 7/23/08-for HPV4 vaccine. Migraines. Diarrhea. 7/31/08-C/O diarrhea, shoulder pain and headache. Diarrhea worse at night actually for last three weeks. Fevers, night sweats, low back pain. Migraines. 8/12/08-Continued C/O abdominal pain, epigastric discomfort, cramping when urinating. 8/26/08-C/O lump at injection site. 9/11/08-C/O tingling in hands and feet. DX with enterogastritis suggestive of NSAID use and moderate hiatal hernia.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022cz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Fibrin D dimer: fine range (normal) After first dose-fine range and .55 (High) After second dose- high range .55.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.        Concomitant product use was unknown by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-243192 (Patient Link).
Patient stated that she felt palpitations.  was given an extra bottle of water given, vital signs taken .  At 1:35 vitals taken again and was taken to ED and handed over to staff for further evaluation.
Mom reported the child developed a low grade temperature of 99.9 with a shivering motion of his body. He did not lose consciousness and was alert and oriented.
I felt nausea, dizziness, fatigue, my heart pounded hard and fast. My pulse was going up to 126. I didn't take any medication for my symptoms. I was in bed for two days. I have received the 3rd dose and experienced symptoms as well.
5:30 pm. Screaming in pain, tense, tried a warm bath, laid on floor, lethargic crying, screaming , moaning, grunting stomach tight, palms of hands red and rough.
Chills, fever, headache.   Symptoms started 10 hours after injection and lasted 36 hours
The patient erroneously received the SHINGRIX vaccine subcutaneously instead of intramuscularly. They presented with symptoms of inflamed and painful injection site. She described the site as tender and warm to touch.
Per EMS, " very mild rash/bumps that began to come up while in observation area. Patient's vitals were assessed and within normal limits. No SOB, chest pain, or low blood pressure." She was given oral Benadryl 25 mg to self-administer and reported relief felt.
Information has been received from a nurse concerning a female in her 20's who on 11-JUL-2008 was vaccinated with the first dose of GARDASIL. Subsequently, the patient experienced a "hard lump", a size of a walnut at the injection site. The patient was not vaccinated in the reporter's office. The patient sought medical attention by contacting the nurse. Additional information has been requested.
Fever, chills and strong headache happened after 24 hours after 2nd dose. Early period started. Lasted longer than usual.
Her daughter passed out on her way out of the doctor's office; this was immediately after her second dose of the HPV vaccine; This spontaneous report was received from the patient's mother via a company representative referring to her daughter, a 12 years old female patient. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.     On an unknown date, the patient was vaccinated with the second dose of human papillomavirus (HPV) vaccine (manufacturer unknown) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis (product origin unknown). Immediately after the second dose of HPV vaccine (manufacturer unknown), the patient passed out on her way out of the doctor's office. The outcome of pass out was not provided.  The causality between passed out and the HPV vaccine (manufacturer unknown) was not provided.  Upon internal review, passed out was determined to be medically significant.
body aches; Shivers; headache; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), CHILLS (Shivers), HEADACHE (headache) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J on 17-Mar-2021 and J&J on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J&J and J&J.    On 17-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), CHILLS (Shivers), HEADACHE (headache) and PYREXIA (fever). At the time of the report, PAIN (body aches), CHILLS (Shivers), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received bivalent booster on 16-Oct-2022 and 27-May-2023. patient received Spikevax 2023-2024 Formula on 22-Sep-2023. Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to MOD-2023-742520 (Patient Link).
newborn patient mistakenly received a DAPTACEL vaccination at the hospital this morning instead of the intended Hep B vaccination with no reported adverse event; Inappropriate age at vaccine administration with no reported adverse event; Initial information received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 day old male patient who mistakenly received a diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at the hospital this morning instead of the intended hep b vaccination with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Jan-2023, a newborn patient mistakenly received a 0.5 ml dose 1 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (strength: standard) (expiry date, lot number: not reported) via unknown route in unknown administration site for immunization instead of the intended hep b vaccination with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age).  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the events (newborn patient mistakenly received a daptacel vaccination at the hospital this morning instead of the intended hep b vaccination and inappropriate age at vaccine administration with no reported adverse event.)  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 the 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.
PT RECEIVED A COVID BOOSTER SHOT INSTEAD OF THE FLU SHOT THAT WAS INTENDED.  SHE HAS PFIZER FOR HER 1ST, 2ND, AND 3RD.  DATES OF 03/8/21, 03/29/21 AND 10/21/2021.  I CALLED MODERNA AND REPORTED TO THEM AND THEY WILL SEND ANY ADDITIONAL INFO WE MAY NEED AND ANY ADVERSE REACTIONS, WILL BE REPORTED.
Mom stated" pt had not slept more than 15 min @ one time since received shots on 29Jan91. Developed diarrhea & sometimes cries nonstop for long periods of time. Pt not seen by MD, but phoned MD, he states sx caused by shots, mom upset
Confusion, brain fog, loss of appetite, extreme muscle weakness with inability to stand by herself and walk, intermittent dry cough, decreased oxygen level
The child had already received the two vaccines (Kinrix and Proquad) in December 2022.
This healthy 45 year-old received his third Anthrax vaccination on 12 July 2004.  Approximately 3-4 weeks later he reports a sudden onset of facial swelling.  His medical records document he was riding his bicycle home from work approximately two hours after drinking a Bing cherry sports drink and eating some peanuts when he felt a tingling with associated swelling to his right upper lip that extended into the right cheek area ("like a cold sore").  He saw the doctor the next day and was given Benadryl with relief of the swelling.  He reports a history of oral numbness with honey dew melons but no problems eating peanuts or cherries. He denied any stings, bites, trauma to the face, new foods or clothing, respiratory distress, breathing difficulty, chest pain, nausea, vomiting, or itching.  He reports no past allergies, reactions, new foods, cloths, travel or shampoos, deodorants or detergents.   He continues to be evaluated since 13 September 2004 to present.  He documents he was "ok for three weeks following AVA #3 then problems began since return home."  He was placed on Benadryl prn, Claritin, Epipen, Flonase for his nose, r/o autoimmune disorder due to low c4, questionable relation to anthrax vaccination as there are case reports of angioedema and anthrax vaccinationquestionable serum sickness related, has knee joint pain."  A RAST showed positive to Kentucky blue grass, cats, peanuts and Bing cherry.  He showed a low complement C4 (16.3), normal ci esterase, cholesterol of 209, BUN/Creatinine of 22/1.3, and eosinophils high at 5.4, otherwise normal labs.  His last episode of facial swelling occurred 14 March 2005 after leaving MD's office.  As of March 16, 2005, he reports continued periodic facial (eyelids, lip, chin) swelling with no further groin (penial) swelling that occurs spontaneously in the afternoon or evenings/nights 3-5 times a month lasting for 8-12 hours with no known triggers.  He no longer eats peanuts or cherries and has no cats.  A single dose of Benadryl 50 mg PO will resolve the swelling with repeat doses periodically required in 2-3 days.  He used Claritin, Flonase and Singulair secondary to allergy response and nightly chest tightness (hard to breath in) from September to December 2004.  He has since stopped the Singulair with no reoccurrence of the chest tightness. He continues to use Flonase and Claritin.  Following a recent physical in 2005, his surgeon grounded him for using Claritin.   He also noticed the onset of headaches over the last six (6) months.  He describes the headaches as an intense pain (7-9/10) with inability to concentrate lasting 3-4 hours located to the sides of his head/temple region.  These headaches occur twice a month.  However, he has had four in past two weeks secondary to loss of a friend (attending a funeral).  A single dose of 800 mg Motrin or a couple of aspirin will relieve the headache.   He admitted to increasing joint pain to both knees and ankles over the last six months that will resolve with a Motrin or aspirin.  He attributes these discomforts to physical activity during the week.  He describes the pain as an ache deep in the joint.
NO ADVERSE EVENT NOTED OR REPORTED. PT MISTAKENLY GIVEN COMBINATION MMRV VACCINE INSTEAD OF SEPARATE MMR AND VARICELLA VACCINES
Redness, swelling & heat at injection site generalized aches/fever & not feeling well at all referred patient to urgent care for antibiotic treatment.
Per the father, the deceased received his first shot of Moderna vaccine on Saturday, 4/10/2021 at a local church. He did not work on 4/11/2021. Worked on 4/12/2021. The deceased was found dead at 6:43 p.m. at his home.
Father called clinic stating the child had hives all over his body. Stated there was no swelling on face/lips/or near airway and that child was not having difficulty breathing. Advised to contact child's pediatrician for guidance on if and how much BENADRYL is safe for the child, and to call 911 if he notices any of the aforementioned swelling or difficulty breathing.
rash at site of vaccine(prevnar) left deltoid 7x7 indurated erythemetous tender macualar eruption Ice, benadryl and motrin
Terrible sharp pain while getting the shot, very sore immediately after receiving the shot, and not able to move shoulder as of Tuesday night. Was in tears several times due to pain, and not able to sleep for the 2nd night in a row due to pain, Not able to extend shoulder very much at all. Not able to lift arm to wash hair, etc.
Hospitalization for altered mental status, multifocal pneumonia, and COVID-19 infection on dates 7/6/2023-7/13/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.