chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/8/2021-numbness started on left two fingers then numbness progressed to the right hand within a day.7/19/2021-started with upper back pain, throbbing in nature started at the spine and moved outward,took Aleve and muscle relaxer without relief .  7/21/2021 started with weakness all over body. 7/22/2021 went to ER was admitted with a diagnosis of Guillain-Barre given IV IG x 5 units with relief, but continues with numbness in bilateral hands and feet L>R.  Now has high blood pressure running 150-160 over 100-106 and believe she is prescribed lisinopril 5mg, taking Aleve for pain and percocet at h.s. Transferred to rehabilitation unit on 7/28/2021.
pt brought to ED with headache and nausea, vomited at home; thought to have come in contact with gas leak exposure at home; pt found to be positive for COVID; blood gases normal; in A Fib with RVR; O2 supplementation; COVID pneumonia; guarded prognosis; pt expired in the hospital
immed following vax pt devel 2'' area red, warm to touch, raised; advised to use cold compresses
Diarrhea; Headache/ it was really bad, she couldn't get rid of the headache; Nauseated; Vomit; coughing; sore throat; Next day she had migraine; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Next day she had migraine), COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (Sore arm) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Dec-2021, the patient experienced MIGRAINE (Next day she had migraine). On an unknown date, the patient experienced COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (Diarrhea), HEADACHE (Headache/ it was really bad, she couldn't get rid of the headache), NAUSEA (Nauseated) and VOMITING (Vomit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Next day she had migraine), COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), NAUSEA (Nauseated) and VOMITING (Vomit) outcome was unknown and HEADACHE (Headache/ it was really bad, she couldn't get rid of the headache) had not resolved.            No Concomitant drug reported.   The first day after the booster it was normal. Then she had a headache and the next day she had migraine, she was nauseated, vomit, diarrhea. She took her migraine pill, it kind of helped her. The next day she felt much better and has been working since. Sometimes she would get a light headache but it did not get worse until 05 Jan 2022, it was really bad, she couldn't get rid of the headache, she took Tylenol and ended up having migraine medication again.
At 1628, RRT was called for a 19 y/o M with c/o dizziness and lightheadness. At first appearance, he was diaphoretic, pale, shaky, cool, and clammy. Head-to-toe assessment completed and all WNL than what was previously mentioned. Vitals: BP: 110/58, HR: 72, RR: 20. Has asthma, NKA, no medications/herbal supplements/vitamins taken that day. This was his 1st dose of Pfizer. Response team gave him icepacks to put on his neck and arms and client stated he felt better. His mother arrived and client and response team informed her of situation. Client declined paramedic/EMT assistance. Over monitoring/evaluation period, client?s condition improved. Skin color returned, no more diaphoresis, skin was warm. Client left facility at 1640, accompanied by mother. Mother drove client home.
pt recv vax 17MAY95 & 2JUN95 pt devel low grade fever, inj site tenderness & several pox-like lesions around the body; MD felt that pt's exp was related to vax; in f/u felt it was wild virus;
Patient started w/ a runny nose that evening, then fever went up to 103 even with Tylenol every 4 hrs, crying with body aches, fatigue, had dark circles under her eyes.  The fever broke on 10/25, continued to be tired.  Returned to school on 10/27/09
Pt requested Janssen vaccine today. Patient denied ever having previous covid vaccine on the pre vaccination checklist. Patient was given the vaccine without any side effects/incident. Upon filling out IRS(Immunization Reminder System) for today's vaccine, it was noted that she had completed her Moderna series in March 28,2021. Patient did not divulge this information to Urgent Care at the time of visit.
This spontaneous report was received from a nurse and refers to an multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 50.4 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA014425.
Approximately 5 minutes after vaccines administered (Gardasil and intradermal flu) pt felt faint on way to waiting room. Skin very pale and sweaty. Sat then laid down in waiting room. BP 100/50. Cool cloth given along with juice. Client monitored by staff. After approximately 10 minutes pt states he is feeling better. Color is noticeably better and BP 105/60 with HR 76. Client sat for an additional 5 minutes before leaving and stated that he felt fine and had a friend to drive him home.  After client feeling better he did tell staff that he has a history of feeling faint after things such as ear piercing.
This spontaneous report as received from a medical assistant (who was also the practice supervisor) refers to a patient of unknown age and unknown gender. On 03-DEC-2013 the patient was supposed to receive PROQUAD (Merck) but a nurse administered MMR II, intramuscularly (dose, LOT # unknown) instead. No symptoms reported. Additional information has been requested.
Dizziness and vasovagal episode. Hx  of vasovagal and seizure x1. Patient went decorticat and immediately awaken after ammonia given.
Onset of fever 101 headache muscle aches and tachycardia approx 130 Ibuprofen 200 and tylenol     symptoms ended by 7 am.
11 hours after injection I woke up (2/11/2021 @ 1:45 AM) with severe chills. Shaking uncontolably -legs and head. Than came body aches, especially my arthritic hand and ankle. Weakness, fatigue, SOB just walking to the bathroom. My temperature during the chills was 99.2, and after the chills subsided, about 3 hours, my temperature went up to 100.6 but never got higher than that. Taking 650MG Tylenol helped ease the discomfort. Was not hungry nor thirsty , did not watch TV, all I could do was lay in bed. Symptoms completely subsided by 8:00AM 2/12/2021.
01/03/22 presents to EC ED for "palpitations and lightheadedness". PMHx of "PAF (not on AC), HTN, DM type II"
Swelling redness warmth within few hours of vaccination 2" x 2" area 48hrs - erythematous macules/papules on vaccinated arm probable Herpes Zoster outbreak mild.
Generalized seizures; 6/26/02; 7/2/02; 7/12/02. No fever.
Started to sweat and then I had ringing in my right ear.; I had ringing in my right ear.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FC3180) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies Latex" (unspecified if ongoing), notes: Known allergies: Latex. The patient took concomitant medications. The following information was reported: HYPERHIDROSIS (non-serious) with onset Aug2021, outcome "not recovered", described as "Started to sweat and then I had ringing in my right ear."; TINNITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "I had ringing in my right ear.". Therapeutic measures were not taken as a result of hyperhidrosis, tinnitus.  Additional Information: Administration time: 13:00 and Adverse event start time: 08:00 was given. Patient did not receive any other vaccine in four weeks. Patient receive Vitamin supplements in two weeks. Patient diagnosed with COVID prior vaccination. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient complained of excessive bruising, swelling, and itching in her arm starting about 2 inches below the injection site and extending down her arm.
Fist cluster headache occurred, treated with sumitriptan. Two events each of the next 3 days. Then 3 events a day ongoing. ran 5 day course of an antiviral last week, no change. Please help.
Patient received second dose of hepatitis B vaccine too early.  Second dose scheduled at 1 to 2 months after first dose, but received second dose in error 12 days after first dose.  First dose given, but patient was transferred to ICU and given another dose prior to 10-23-22 discharge on 10-22-22.
Within the 15 minutes patient received her second dose, we checked in on her. She stated she was flushing (no redness was showing), had difficulty breathing, developed a rash, and her face was numb (she said paralyzed, but no dropping or anything noticeable). Patient is allergic to Benadryl so the pharmacist administered an EpiPen and called 911. The ambulance came in and took her to nearby emergency room.
immed bilat periorbital erythema, 2 hives on each cheek; 98.3; 82-20 - 100/60; erythema & hives disappeared in 4-5 mins; kept an addtl 20min for observation;
Got FLUZONE HD 10-12-16; few days later pt and spouse experience: Nausea, vomiting, diarrhea and weakness. Symptoms lasted 3-4 days.
Headache, Myalgia, BODY ACHES, HA, CHILLS
Joint and muscle pain, headache, fatigue that lasted for approx. 24 hours then went away EXCEPT left hip pain that was not there until after the covid booster and has gotten worse over time. My left hip pain has gotten so bad in the last 24 hours that I?m having a hard time walking, sleeping, etc. Have been taking Aleve but the pain isn?t getting better.
Pt. went to emergency department 2 days after receiveing pneumovax in R arm.  Treated with Rocephin 1 gm. IM for cellulitis.  Instructed to take Cephalexin 500 mg. TID for 10 days and was given vicodin for pain.  Cellulitis extended from injection site down to elbow.
TOOTHACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced toothache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of toothache was not reported. This report was non-serious.
Large swollen dark purple rash, smaller pink rash, itching.  Flu like symptoms, aches and a headache.
The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) to be not applicable.    No treatment medication was provided. No concomitant medication was provided.
Patient experienced acute pulmonary embolism approximately 8 days after administration of the J&J vaccine. He did not have low platelets. No clear cause of the PE was found. It was thought to be possibly related to superficial thrombosis of his upper extremity secondary to IV that was placed 2 days prior when he was briefly admitted for workup of heavy hematocheiza, at which time he was found to have a mild anemia and discharged. He was treated inpatient at Hospital. I am not sure of the where he obtained the vaccine or the exact date.
Child's date of birth was recorded incorrectly in the chart, and HPV vaccine was given at age 7 instead of the age recorded in the chart as age 10.  There were no known side effects from the vaccine.
Approx. 10 minutes after receiving Tdap injection, client became pale, and felt like he was going to "pass out" . Client lied down with feet elevated. B/p 110/64 AP 80 Resp. 20. Fan turned on in exam room. Client's father present. Clients father reports that client has a hx of migraines and today was the first day he started his new migraine medication and he had his first dose today this am. Client reports that he did eat earlier today. Father is unsure of name of new medication. Client saw his PCP , Dr. yesterday. Father also reports that client has ADHD and that he stopped his son's ADHD medication earlier this summer and both he and clients PCP agreed yesterday to not restart it. Client's father also report that client has had 3 seperate accidents with concussions and that is why his PCP believes he is having migraines. Offered to call Dr. or to be seen by PMAH and father declined. At 3:10 client reports he is feeling fine with no complications. Instructed client and clients father if client starts to feel worse to contact PCP or take to PMAH.Client allowed to leave with father at 3:10 pm.
Vertigo; nausea; headache; swollen glands; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration on 21Mar2021 at 14:30 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and allergic to plants and pollen. 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 simvastatin, thyroid (ARMOUR THYROID), progesterone, and estradiol from unknown dates for unknown indications. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) and montelukast (SINGULAIR) from unknown dates and experienced allergy. On 22Mar2021 at 16:45 the patient experienced vertigo, nausea, headache, swollen glands, and fatigue. 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 vertigo, nausea, headache, swollen glands, and fatigue were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow up attempts are needed. No further information is expected.
local pain 24 hours post injection. Local redness 24 hours post injection. Increased redness and swelling deltoid/upper arm with worsening arm pain and swelling 60 hours post injection, limited to upper lateral arm. Myalgias/malaise 60 hours post injection. Treated with warm compresses, diphenhydramine, cephalexin to cover possible cellulitis
Side effects was sore in arm of the injection site. Then about 4th hour got hot flashes for a couple of minutes. 6th hour had a weird sensation in chest like where my heart is located. Felt like a flutter of the heart or a small pin needle pain and I had that feeling off and on for about 8 hours untill I went to sleep about 3am. Woke up next day after shot and arm was more sore and didn't have that chest ache pain anymore untill I started off my day got outside and started feeling that aches in chest feeling not so bad but definitely weird  and had a little dizziness about 2 times
Approx. 1 hr after vaccine employee stated her vision was going blurry, head was dizzy and she was hot. She was laid down with feet elevated and ice packs applied. B/P continued to elevate. Ambulance called. Employee started to experience chest pain and nausea.
Nurse reported 2 temperature excursions; nurse administered fluzone quadrivalent  from the punctured multi dose vial to a patient after 1 week following the excursion.; Initial information received on 10-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 69 years old male patient who experienced nurse reported 2 temperature excursions and nurse administered Fluzone quadrivalent  from the punctured multi dose vial to a patient after 1 week following the excursion while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Feb-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B vaccine suspension for injection (lot number: UJ694AB and expiry date: 30-Jun-2022) once via intramuscular route in the right deltoid for immunization and TUBERSOL (TUBERCULIN TEST) 0.1 mL solution for injection (lot details, route, frequency: unknown) in an unknown administration site for tuberculin test. .  On 09-FEB-2022 the patient developed nurse reported 2 temperature excursions  (product temperature excursion issue) and nurse administered fluzone quadrivalent  from the punctured multi dose vial to a patient after 1 week following the excursion. (wrong technique in product usage process) (latency: same day) following the first dose intake of TUBERCULIN TEST and INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (product temperature excursion issue).  At time of reporting, the outcome was Unknown for the event product temperature excursion issue and wrong technique in product usage process.   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.
The patient was seen in the ED and brought in by EMS on 8/3/23. Earlier that morning, she had labs drawn with abnormal lab results (sodium at 123), which prompted her to be seen in the ED. In the ED, she also reported dark stools, nausea, weakness, and exacerbation of chronic headaches. She was admitted 8/3/23 for hyponatremia. A COVID PCR test performed on 8/4 during her admission resulted as positive. Discharge diagnoses include hyponatremia, SIADH (syndrome of inappropriate ADH production) and COVID-19. During admission, she was started on oral dexamethasone and placed on supplemental O2.
Developed fever of 102 degrees, extreme pain in Left arm, shooting pain into neck and chest, lymph node swelling, ear pain,  lasting 4 weeks.  Given Keflex by Dr.
Patient said she developed a large rash on the arm she received her injection 9 days after receiving it.  It resolved on its own in several hours.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown. It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional asked if the patient experienced a mild localized reaction from the SHINGRIX, what should he/she expect after the second dose, the same reaction or worse or no reaction. No further details were available at the reporting time.
Erythematous macular lesion (Urticaria) generalized - Trunk and extremities.
Had a very intense right earache that lasted for about 30 minutes, with some neck pain. This disappeared after 30 minutes entirely.
The only side effect I had with the shot was very mild discomfort at the point of injection.  About 3 & 1/2 months later on Dec. 27, 2023 I caugh Covid.  I tested positive on 2 home tests.  My doctor prescribed Paxlovid, which I began taking on Dec. 28.  The symptoms I had were strictly upper respiratory.  I had nasal and head congestion and some fatigue.  I had no other symptoms.  They began reducing within 24 hours of taking the Paxlovid.  The entire course of the illness was around 4 days.
shot administered from syringe at 8 hour mark; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (shot administered from syringe at 8 hour mark) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (shot administered from syringe at 8 hour mark). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (shot administered from syringe at 8 hour mark) had resolved.        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.   Concomitant medications were not provided.  No treatment details are provided.
Pt. reported 2-3 days after shot swollen glands/fever would come and go. Poor taste/denied swelling of face/no hives, no difficulty breathing, no dizziness or weakness.