chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has no history of headaches. The patient reports severe headaches starting the day after the Moderna covid vaccine morning and night for 3 weeks. Following this more intense daily 3 week period, headaches persisted multiple times a week for 3 months afterwards. Still has some random headaches.
Swollen red spot at the point of vaccine approx. inch in diameter. By 4/24/2016 it was about 6.5 inches, bright red, swollen, hot.
Red Rash on palms of hands and bottom of feet, along with fever between 99-100, followed by rash with bumps on arms. Along with vomiting, and shortness of breath, (labored breathing), alot of stomach pain and fever has reached as high as 106.2 and has reached over 104 for the 5 days straight. Has continued to vomit every day since 7/2/13. Has vomited blood on one occasion. Since this started. Fever is still present today on 7/11/13. We are still monitoring the situation and hoping that there is some resolve in the very near future as we are on day 9 right now and our son is miserable and complaining of alot of stomach pain.
Hospitalization: 12/12/2022 - 12/13/2022 (23 hours) Presentation to the ED: Chest Pain COVID + date: 12/12/2022 Treatment: Zithromax (prescribed by PCP).  Discharge to: home  Moderna 031B21A 4/22/2021 Moderna 039B21A 5/20/2021
Extreme tiredness the day after along with fever and nausea 2-3 days after vaccine a gradual onset of swollen throat without pain. Patient reported difficulty swallowing anything not heated. Patient said throat issues still persisting but improving 2 weeks after vaccine.
severe allergic reaction; hives; swollen fingers; numbing lips; tingling tongue; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System . A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 11Feb2021, at 14:00 (Batch/Lot Number: CL9264; at the age of 65 years old) as dose 2, single for COVID-19 immunisation. The patient has no relevant medical history and concomitant medications. He did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2, administered in the right arm on 22Jan2021, at 15:00 (Batch/Lot Number: CL3248; at the age of 65 years old) for COVID-19 immunisation. The patient reported that he has never had any allergic reaction before he had the vaccine. On an unspecified date in 2021, after the second shot, he had a fish (tilapia) taco and had a severe allergic reaction, hives, swollen fingers, numbing lips, and tingling tongue. The events were reported as non-serious by the consumer. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. The patient took diphenhydramine hydrochloride (BENEDRYL) and went to an emergency clinic and was given a shot of diphenhydramine hydrochloride and steroid. The outcome of the events was unknown.
Rash appeared on chest 17 days after vaccine spread to torso, back and legs. No itching or discomfort just rash
6 day history R sided chest rash w/ skin hypersensitivity consistent with shingles rash. Received covid vaccine 1.5 days before. Seen by PMD over telehealth appt and dx with shingles. Had VZV at 5 yo. No prior vaccine for VZV.
Pounding headache; Itchy entire arm; Injection site red; Injection site was swollen; Inflammation on the injection site; Warm to touch, injection site hot; Discomfort on the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot), DISCOMFORT (Discomfort on the injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site was swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine, Lung nodule and Cellulitis. Concurrent medical conditions included Seasonal allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE N S), ALBUTEROL SULFATE (ALBUTEROL) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot) and DISCOMFORT (Discomfort on the injection site). On 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site was swollen). On 20-Jan-2021, the patient experienced HEADACHE (Pounding headache) and INJECTION SITE PRURITUS (Itchy entire arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and STEROIDS at an unspecified dose and frequency. At the time of the report, INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot), DISCOMFORT (Discomfort on the injection site), INJECTION SITE ERYTHEMA (Injection site red), INJECTION SITE SWELLING (Injection site was swollen), HEADACHE (Pounding headache) and INJECTION SITE PRURITUS (Itchy entire arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included hot and cold compress.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 30-OCT-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Red swollen circular area around shot lasted 1 day then changed, fever and headache lasted three days, swollen area changed from circular into two lines approximately 3/4 in wide about 1 inch apart. Both lines of swollen area were on and above shot mark and wrapped about half way around arm.  They have slowly faded and now two weeks later less red but still visible.
Muscle tensed up from injection site into side of neck after 1st dose; Injection site sore after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Muscle tensed up from injection site into side of neck after 1st dose) and VACCINATION SITE PAIN (Injection site sore after 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0u7bz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (Muscle tensed up from injection site into side of neck after 1st dose) and VACCINATION SITE PAIN (Injection site sore after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, MUSCLE TIGHTNESS (Muscle tensed up from injection site into side of neck after 1st dose) and VACCINATION SITE PAIN (Injection site sore after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Followup received on 16 Jul 2021: Event outcome updated
I have had body aches, headaches, tiredness, nausea (don't feel like eating), ater eating I get stomache cramps and diarrhea, chills and a bump at injection site (approximately 1/4" in diameter). The injection site still has a bump under the skin the size of a pencil eraser. I called and told a nurse, but she said "if I feel I need to come into office to come in, but this sound like a normal reaction".
Lot # expiration had been extended and vaccine had remained frozen until date of administration but was given 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so revaccination was not necessary.  No adverse side effects reported by Patient.
product was exposed to a temperature of up to 49.4 F for 1 hour 30 minutes/no AE; one of their staff still inadverently administered a dose of IPOL to a patient/no AE; Initial information was received on 27-Jan-2020 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 9 years old male patient who received a dose of IPV (VERO) [IPOL] that was not suitable for use after it was exposed to a temperature of up to 49.4 f for 1 hour 30 minutes.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE (MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE) for Immunisation.  On 27-Jan-2020, the patient received 0.5 ml dose of suspect IPV (VERO) (lot T1F541M) via an intramuscular route at the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to incorrect product storage and poor quality vaccine administered.  It was reported that opened IPOL multi-dose vial (MDV) should not be used, and instructed the staff not to use the opened IPOL MDV that was exposed to a temperature of up to 49.4 F for 1 hour 30 minutes due to the refrigerator door being left ajar during vaccine counting, but instead to use an unopened IPOV MDV. However, one of their staff still inadvertently administered a dose of IPOL to a patient using the MDV that had been opened, and which was exposed to that temperature excursion.  At the time of reporting, no adverse event 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.
Case previously recorded as MA2009-3999. Initial case report received from a physician, via Novartis Medical Communications, on 10 NOV 2009. A nurse had S-OIV FLUVIRIN (batch no. 102042P1) sprayed into the eye while withdrawing a dose from the MDV. The nurse is not experiencing any eye irritation, redness or pain. The eye was rinsed with water. No adverse event was reported. MedCom reference no.: NA09-007930.
After receiving the shot, all was well.  It was only after the next night (24 hours) that I experienced a fever, chills, muscle aches and headache.  I took Tylenol to lessen the headache and the fever.  By the next morning, my fever had broken from 99.9 to 96.0.  The chills were considerably lessened and the headache was gone.
(Immediate reaction after injection was not alarming: pain at injection site and extreme tiredness, slept without waking for 36 hours from 11/05 8pm until 11/07 8am. Tiredness from then until 11/14.) Serious events starting 11/14/2020: Slight, intermittent dizziness starting on 11/14/2020. Visit to clinic 11/16 with Dr. diagnosed bradycardia (44/min), EKG revealed some heart block. Doctor consulted with cardiologist who read EKG as 3rd degree heart block. From clinic visit with cardiologist on 11/18, was admitted to hospital, and monitored until pacemaker could me implanted on 11/19.
pt recv vax NOV92 & devel rt upper quad tenderness;it was assumed to be a flair-up of an old chronic ulcerative colitis;colonoscopy did show a mild inflammatory rxn;blood chem revealed elevated liver enzymes & positive hep B surface antigen
The patient is a healthy 44-year-old female with a history of adverse reaction to IIV characterized by a 45 x 30 mm patch of erythema edema warmth and pruritus which resolved 5 days post vaccine receipt.
Sore Arm; Felt like in a daze; Memory lapse; Seems like he lost it; Got the chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Felt like in a daze), MEMORY IMPAIRMENT (Memory lapse), SENSORY LOSS (Seems like he lost it) and CHILLS (Got the chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Felt like in a daze), MEMORY IMPAIRMENT (Memory lapse), SENSORY LOSS (Seems like he lost it) and CHILLS (Got the chills). At the time of the report, PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Felt like in a daze), MEMORY IMPAIRMENT (Memory lapse), SENSORY LOSS (Seems like he lost it) and CHILLS (Got the chills) had resolved.            No treatment information was provided.
Pt had immunizations 8/4/06. On 8/5/06 went to the ER with 2 inch hot, red area w/ blister on deltoid(per mother's report). By 8/11 area had completely healed. Immunizations were given in both arms, but unsure of which ones in which arm.
pt recv vax 30JUN04 & less than 12hr later exp severe muscle pain in the neck & arms; pt then exp flu-like sx for approx 2 wk;
24 hours after receiving her first dose of Gardasil, the patient developed edema in her face, hands and feet, which lasted until 2-14-08.  She also had generalized itching from the neck down, which lasted for 24 hours.  She reported these side effects to her physician on 2-14-08.
Nurse administered 1ml of Moderna vaccine instead of 0.5 ml of vaccine.  Patient reports tiredness and a sore arm morning of 1/14/2021
21 year old female with a history of splenectomy 3/03 overseas. On 11/4/04 she received a SC injection of pneumococcal polyvalent vaccine 0.5ml in right upper arm. She subsequently developed pain, redness, swelling in the extremity which required hospitalization. Temperature to 101-102 degrees F. Follow up 01/26/05: I have no specific details as to treatment as this occurred in a different location as previously reported. Patient has recovered.
Paleness, itchiness, lethargy, dizziness, nausea, fever loss of appetite, rash, dark circles - between 10:10 AM and 4 PM of same day. Approx 5:30 pm child developed abrupt onset of high fever of 104.5 and became disoriented and had some trouble breathing.    Continued lethargy and malaise on 9/15/2010
Throat was a little swollen by the first nite. Second day had bump and red swollen rash on left arm size if silver dollar and by third day it had become a little larger and was itchy.
Patient is a 50 yo female s/p full Pfizer vaccination: dose 1 on 3/27 and dose 2 on 4/17. Patient presents to the ED on 7/25 with chief complaint of fatigue, cough, headache, and nausea for 1 day. She reports recent exposure to COVID-19. Rapid COVID test results positive on 7/25.
Information has been received from a licensed visiting nurse concerning a 36 year old female patient who was vaccinated with MMR II as a child. On an unspecified date, the patient experienced a rubella titer that was 0.1 point lower than required for professional school. Recently, the patient was given another dose of MMR II. At the time of reporting, the outcome was unknown. The patient was seen in office. Additional information has been requested.
This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included unspecified hepatitis vaccine. The patient experienced hot flashes in all the body, nausea, abdominal pain, syncope and white lips on an unspecified date with outcome of unknown.
Information has been received from a registered nurse (RN) concerning an approximately 80 year old female with diabetes who in November 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  The RN reported that in November 2005, after vaccination, the patient's arm "swelled up like a softball".  Unspecified medical attention was sought.  Subsequently, the patient's arm swelling fully resolved.  Additional information has been requested.
pt recvd vax 21FEB95 @ 1500 hrs & devel gen szs; @ 1800 hrs pt was treated @ hosp & released home; pt seen by MD 22FEB95 for f/u;
L deltoid inflamed swollen, hot to touch. No fever. Child fine otherwise per mom. Eating and playing normal. Hep A administered L deltoid.
Fatigue; it felt that someone had taken a cheese grater  to her skin; Joint pain; Nausea; Injection site swelling; Injection site Pain; Massive headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 17th May 2019, refer linked case US2019149376).   On 13th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, several hours after receiving Shingrix, the patient experienced joint pain, nausea, injection site swelling, injection site pain, headache, fever and paresthesia. On 15th August 2019, the patient experienced fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the joint pain, nausea, injection site swelling, injection site pain, headache, paresthesia and fatigue were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the joint pain, nausea, injection site swelling, injection site pain, headache, fever, paresthesia and fatigue to be related to Shingrix.  Additional information received were as follows: The patient experienced joint pain, swelling and pain at the injection site. The patient experienced nausea, massive headache and felt that someone had taken a cheese grater to her skin. On the 12th hours after receiving Shingrix, the patient experienced fever (the patient's body temperature was recorded as 102.7 degree F.) that lasted for one day. On the reporting date, 2 days after receiving Shingrix, the patient had a low grade fever (the patient's body temperature was recorded as 99 degree F.) and was experiencing fatigue, joint pain and soreness at the injection site, but was less swollen.
Developed shingles with rash and pain on right side of chest/torso/back and under arm.
10-5-10 received flu vaccine. 10-06-10 developed abscess & limited painful movement in arm. 10-07-10 drained abscess by Dr. Still limited & painful movement not able to achieve normal tasks & movement 10-11-10 revisited Dr more fluid developed in arm. 1-27-11 revisited Dr due to inflammation & pain was referred to orthopedic Dr.
Recvd vacine around 3 pm, around 9 pm pt. had strange feeling in throat and chest felt heavy like heart arrack-went to ER for observation- pt was fine.
Headache, Myalgia, Arthralgia, Fatigue, Flu-like Symptoms Narrative:
Patient received the first dose of her covid vaccine by Moderna in her left arm at 1445. Lot number 023M20A. Exp. 8-10-2021.  Patient had no pain with injection. Tolerated well. Approximately 30 seconds to one minute after injection patient reported to nurse that her mouth and throat felt dry. This nurse asked the patient if she was feeling anything else different and if her throat felt itchy. Patient reported that her throat did feel a little itchy. This nurse called for assistance. RN obtained Dynamap to take patient vital signs. This nurse stayed by patient's side at all times. NP responded and was by patient's side throughout event. Patient now reporting feeling very hot. Ice pack applied to back of her neck. Initial vital signs 184/87, Map 123, HR 119. Patient tachypnic and tachycardic. Pulse ox WNL at 99%. Lung sounds clear. Radial pulse obtained, rapid. First responder called for with overhead page. Next vital signs 189/79.map of 113. HR 116. Patient still tachypnic and tachycardic with a pulse ox of 99%. Patient reports she is feeling dizzy and hot still. Able to answer questions and was oriented at all times. Dr and first responder team arrived at scene. Patient able to answer questions. Is still dizzy and not feeling well. Patient transferred safely to cart and strapped in with safety straps. All patient belongings placed on cart with her. Patient taken to ED for evaluation.
pt had no adverse reaction, however he is 12 years old and the vaccine is not approved for those under 18. Pt was in the clinic for 20 mins after vaccine administration with no adverse reaction. Pt mother was called 2 hours later and she states child is fine.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients medical history, and concurrent condition and concomitant therapy were not provided. On 12-JUL-2016 the patients were vaccinated with improperly stored GARDASIL (lot # M014929, expiration date 29-MAY-2017, dose and route were not reported). There was no previous temperature excursion and data logger was not involved. The vaccine had been improperly stored under temperature dof 1 degree Celsius for 48 hours. No adverse effects were reported. This is one of several reports that received from the same source. Additional information is not expected as no consent to contact the healthcare professional.
I developed flu symptoms, with a vey bad cough, low grade fever and chills  the cough is very bad and unexpected.   no problems with previous shot 1 and 2
Swollen lymph gland to golf ball size in left armpit noticed 36 hours after booster vaccination given.
Case number PHEH2011US01477 is a combined initial and follow-up report received from a VSS and a physician respectively on 10 Aug 2011 and 12 Aug 2011. This report refers to a 15 year old female patient. She was vaccinated with Menveo intramuscularly on 08 Aug 2011. But, the patient was vaccinated with only the Men A lyophilized powder component which was reconstituted with sterile water instead of Men CYW-135 liquid conjugate. No adverse event was reported following this drug administration error.
26JUL94 pt recvd vax & dad called on 27JUL94 pt was having fever of 101.5 under the arm; pt was fussy & irritable; dad advised to given plenty of fluids & APAP-if fever gets higher to call ER; pt also exp chills & vomited ER called;