chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficult walking around; every bone on my body hurts from toes to hat; Chills like freezing cold; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult walking around), BONE PAIN (every bone on my body hurts from toes to hat), CHILLS (Chills like freezing cold) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical history was reported by reporter.  Concomitant products included LISINOPRIL, ATORVASTATIN, DICLOFENAC, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (Chills like freezing cold) and HEADACHE (Headache). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficult walking around) and BONE PAIN (every bone on my body hurts from toes to hat). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 10-Jan-2021, CHILLS (Chills like freezing cold) and HEADACHE (Headache) had resolved. At the time of the report, GAIT DISTURBANCE (Difficult walking around) and BONE PAIN (every bone on my body hurts from toes to hat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patients reactions to the first dose settled down after few days   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2021: No specific follow-up information recorded. On 10-Jul-2021: Events outcome updated from unknow to recovered resolved
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates in March 2017 (reported as since 02-MAR-2017), the patients were vaccinated with RECOMBIVAX HB (lot #: M035487 with expiration date: 23-FEB-2019 and lot# M042322 with expiration date 21-FEB-2019) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 0°C but less than 1°C for 59 minutes without any previous temperature excursion; this information was registered in a digital data logger. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013305: US-009507513-1703USA011239:
TYLENOL for fever. Solely skin & GI manifestations - avoid milk & acidic foods.
Two weeks after the vaccine, that night my stomach was upset by the time I took the TUMS my stomach was upset and I was throwing up and it was coming from both ends, by the morning I could not get out of the bed and had to call ER. Went to the ER and was told I had stomach flu and received morphine, pepcid, zofran and felt much better
12/25/21 presents to ED for "shortness of breath". PMHx of "OSA on CPAP, asthma, unprovoked PE in 2008 and was on 2 years of anticoagulation"
Had Menactra 11/03/08 state Temp not sure of degree did not have thermometer to take was using Tylenol q 2 hour and had chills.Today temp 100 ax.State had presure in chest, body and bones pain, eyes hurting and sensative to light.  Left arm pit is swollen the are of vaccine has difficulty and pain on elvating left arm.
Local skin reaction,; swelling in throat.; swelling at site; very itchy at point of injection.; This is a spontaneous report from a contactable consumer. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 5318) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00(at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history included latex allergy and sulfa medicine allergy (sulfonamide allergy). Concomitant medications included bupropion hydrochloride (WELLBUTRIN) for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 16:15, the patient experienced local skin reaction, swelling at site and in throat and felt very itchy at point of injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events local skin reaction, throat swelling, vaccination site swelling and vaccination site pruritis were recovered on unknown date of 2021.  No follow-up attempts are needed. No further information is expected.
On 11/10/2021 The patient was 16 weeks pregnant and was in for her prenatal follow-up appointment in OB.  She asked if she could get her second covid 19 vaccine and was informed, yes.  She was accidentally given the Pfizer BioNTech pediatric formulation (10 mcg) of 0.3 mL.  When the medical assistant realized her error, she was told to give an appropriate adult Pfizer covid vaccine dose [0.3 mL  (30 mcg)].  Misunderstanding those instructions, she gave an additional 0.6 mL of the pediatric formulation making a total of 0.9 mL given (45 mcg).  On 11/19/2021 @ 2:07  I called to follow-up on the Pfizer covid vaccine that the patient received on 11/10.  She received a peds dose and then an adult dose.  She said she had no symptoms except her arm was sore for almost 3 days; whereas the 1st dose (10/13) she said she had no symptoms.  I informed her that because she received a higher dose than normal and that she is 16 weeks pregnant, that I was going to fill out a VEARS report just as a precaution.  She stated understanding and appreciated the follow-up call.  Estimated due date of baby is 04/08/2022 (by LMP) and 04/23/2022 (by ultrasound)
Syncopal episode. Patient minimally arousable for 10 min. Emergency services called. Monitored in ED for a few hours, then sent home.
On Thursday red, raised, bumps diaper area.  Friday pm fluid filled blisters, itchy, moved to back, chin, legs.
Pt presented to office on 3/21 in a.m. with L arm, red, swollen & warm to touch - temp was 99.9 - per parents pt. had fever & swelling the previous evening.
Swelling in arm reported and upper left arm. Hand real sore and sensitive, swelled up and couldn't even seen knuckles. Burning only when laid down in knuckles. Knuckles still swollen, but prednisone did help.
patient was given covid vaccine. he stated that he had needle phobia. the vaccine was given without issue. he proceeded to the waiting room to be observed for 15 minutes. customer in line and technician at registered saw patient lost contentiousness briefly but quickly came back. pharmacist came immediately out to patient. he was confused and disoriented but responding appropriately to questions. 911 was called. pharmacist on duty stayed with and observed patient until paramedics arrived.
Fatigue, Lack of Appitite, associated with skin rash and local immunization site redness, warmth, tenderness with 14 cm diameter
I experienced fluttering in my chest and listened to my heart using a stethoscope.  I noticed an irregular heart rhythm (PVCs) and skipped beats. I went to my PCP and an EKG confirmed what I heard. No family history of heart defects. All labs and BP within normal limits. Cardiologist also confirmed arrhythmia and noted it was highly unusual for a person my age and good health to experience these symptoms.It puts me at high risk of stroke and/or heart attack.
Itchy breakout of the skin surrounding my neck and upper chest, which continued up into hairline.  I reported to my internist listed here and used cortisone stick to treat the itching.  It was a month before this began to subside, and I have a scar in one spot on my chest.
Fever 104.0 degrees/lethargic, blisters on back, face & chest. ZITHROMAX & BENADRYL.
Rash, swelling, hot, large swollen area, hard especially at site. No fever. Pt given antibiotic.
This spontaneous report was received from a licensed practical nurse (L.P.N.) (also reported as Licensed Vocational Nurse - L.V.N.). On an unknown date, the L.P.N. stated that the packing of MMR II (Lot# L027591; expiration date 23-JUL-2017) and sterile diluent (unspecified lot/expiration) appeared too similar and products could be confuse. The reporter denied administration of MMR II doses to patients. Also, the MMR II was accidentally left out because practice staff thought it was diluent. Additional information has been requested.
No adverse events. Child rec verbal dx of "chicken pox" from NP. child has had immunization for varicella. 4 other children from same day care reported s/s of varicella within short period of time. Four all received varicella imm but at different times.
After receiving the vaccine while in the observation area patient's vision started getting blurry and he started feeling dizzy. (about 10 minutes after vaccine) He walked back to talk to us, while pharmacist was asking him questions he swayed and fainted. Pharmacist caught him and lowered him to the floor. Called 911 and paged MIC. Pharmacist stayed with the patient who gained back consciousness and placed him in recovery position until paramedics arrived.
low grade fever (99.5), significant left arm pain radiating to neck, ear, hand, and fingers, arthralgias, myalgias.
Extreme fatigue, chills, headache, joint and muscle aches, nausea.
dark urine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (dark urine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced CHROMATURIA (dark urine). At the time of the report, CHROMATURIA (dark urine) outcome was unknown.            No concomitant medications or treatment details provided.
Initial and follow up information has been received from a registered nurse and doctor's office concerning a 55 year old white male patient, with hypertension (HTN) and coronary artery disease (CAD) and no know drug allergies, who on 11-JUL-2006 at 14:30 pm was vaccinated (route unknown) in the deltoid with a first dose of Pneumovax 23 (Lot # 650329/0747P) which expired on 19-APR-2006. The nurse originally reported that the patient did not have any adverse symptoms and unspecified medical attention was sought. Follow up information from the physician's office indicated that "the patient did not have any reaction to the injectable except a sore left arm" (onset date unknown). It was reported that "after checking supplies-realized patient was injected with an expired [pneumococcal 23v polysaccharide vaccine] inj." It was reported that the "patient was not ill, came in for medication refill only." No product quality complaint was involved. Additional information is not expected.
high temperature of 72.7F out of range for 7 weeks with no adverse event; patients were administered post excursion with no adverse event; Initial information was received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases US-SA-2023SA304864 and 2023SA305537.  This case involves a 27 years old male patient who experienced high temperature of 72.7f out of range for 7 weeks and influenza quadrival A-B vaccine [FLUZONE QIV] were administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2023, the patient received a 0.5 ml, once dose of suspect influenza quadrival A-B vaccine (Suspension for injection)  (lot: UT8055JA, expiry date: 30-Jun-2024 , strength: standard) via intramuscular route in unknown administration site for Immunisation.  On an unknown date, high temperature of 72.7f out of range for 7 weeks with no adverse event (product storage error) (unknown Latency)and patients were administered post excursion with no adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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 and Regulatory Authority 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.
Patient developed a rash from the vaccine. He went to an urgent care clinic who stated that it was atopic dermatitis. The rash is still present to this date despite over the counter treatment recommended by urgent care provider.
Initial report received on 11 December 2009 from a health care professional. A 54-year-old male patient had received a fourth dose of FLUZONE (lot number U3270GA) on 10 December 2009 at 10:00 am. The patient receives kidney dialysis; however, he declined to provide any further information regarding the circumstance surrounding indication for kidney dialysis. On 10 December 2009, the patient was seen in the office for a possible infection at the dialysis catheter site, and was prescribed KEFLEX, and he was administered the FLUZONE vaccination. The patient took the KEFLEX at 4:00 pm that day and his lips and "palms" started to itch. The patient took the second dose of KEFLEX at 21:00 pm the same day and experienced more itching. Following the third dose of KEFLEX (date and time not reported) the patient's itching worsened and he subsequently developed chest tightness. It was not reported whether the patient had received medical evaluation or treatment for the symptoms. Per the patient, he has taken KEFLEX in the past without any adverse events; and he has not experienced any adverse events with prior influenza vaccinations. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
throat tightening, wheezing and itchiness, provide patient with o2 via nonrebreather and administered epipen
severe migraine-rt arm inj site;has falling asleep sensation;upset stomach;pt going to ER;
p/3rd shot anthrax rash became more severe;saw MD;tx:Piriton-much relief;rash came back on& off again p/discontinuation of meds;react more severe c/generalized hives w/big wheals;quality of life compromised w/reoccurrence of rash;
A pharmacist reported after pt recv intradermal vax of Td instead of PPD & developed a ``dollar-bill'' sized area of redness & induration at inject site
4cm x 3.5cm right thigh, purple, warmth, inconsolable, screaming, behavioral change and no smiling. Fussy. Left thigh looks great.
Infected with COVID-19; Infected with COVID-19; This is a spontaneous report from a contactable other healthcare professional. This other HCP reported for a patient.  A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced infected with covid-19 on an unspecified date. The reporter mentioned that, reporter had a friend that had received full Pfizer vaccine for COVID 19 and recently was confirmed that patient infected with COVID 19. Reporter did not know any additional information, although it sounds like the disease was not severe and there was no hospitalization yet. While not an adverse event relating to the vaccine itself, reporter thought this would be information the team would want to know. The patient lab test included sars-cov-2 test was positive on unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
his hand itched, late onset; delayed hypersensitivity reaction; Itching; A spontaneous report was received from a physician who was a 57-year-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced itching and a delayed hypersensitivity reaction, tuberculin reaction.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 025J20-2A) for prophylaxis of COVID-19 infection.   On 29-Dec-2020 patient experienced itching.  Then, after 10 days on 07-Jan-2021, his hand itched and he experienced what he referred to as a delayed hypersensitivity reaction, a tuberculin reaction.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, itching and a delayed hypersensitivity reaction, tuberculin reaction, was not provided.   The outcome of the events, itching and a delayed hypersensitivity reaction, tuberculin reaction, was not reported.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded
Abnormal menstrual experiences. Bleeding between periods, 4/5 and 4/9. Heavy, lengthy period 4/18-27.
Red, hot, swollen itchy at injection site, only occured 8 days after, was fine before hand
Pt felt dizzy upon taking vitals pt stated she felt ok and wanted to go home vitals were normal
Painful swollen lymph nodes on the right supraclavicular area and lower right side of the neck; Painful swollen lymph nodes on the right supraclavicular area and lower right side of the neck; Administration date of second dose was 15Feb2021 and Administration date of first dose was 11Jan2021.; This is a spontaneous report from a contactable physician. A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via intramuscular route of administration, on 15Feb2021 at 13:00 (at the age of 45-year-old), as dose 2, single in right arm for COVID-19 immunization at Public Health Department. The patient's medical history included seasonal allergy and sinusitis. Patient had known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via intramuscular route of administration, on 11Jan2021 at 01:00 PM, as single dose in right arm for COVID-19 immunization. Patient did not receive other vaccine in four weeks after COVID vaccine. Patient took first dose on 11Jan2021 and second dose on 15Feb2021, which was considered as an inappropriate schedule of vaccine administration. On 16Feb2021 at 12:00 AM, 23 hours after second dose of vaccine, the patient experienced painful swollen lymph nodes on the right supraclavicular area and lower right side of the neck. Events led to Physician office visit. The patient received treatment for the events which included hot packs, acetaminophen and doxycycline. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not resolved.  Information about lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
no adverese event; expired product administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age or gender.  The patient's concurrent conditions, medical history or concomitant medications were not provided.   On 20-JAN-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 1ml injection once (lot #T014589 with expiration date: 25-OCT-2021; strength and route of administration were not reported) as prophylaxis. No additional adverse events were reported.
Development of respiratory problems, leading to pneumonia and eventually pulmonary embolism, leg deep vein thrombosis, and ultimately death on 03/17/2022.
pt recvd vax & exp h/a which subsided; p/dose 2 exp h/a & achiness; these sx subsided; achiness lasted 24 hrs;
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 20-Dec-2010. On 23-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Starting 5 days after, itchy red  area on left wrist. Today area is larger and puffy.
Information has been received from a pharmacist referring to a 73 year old female patient. The patient was allergy to penicillin. Concomitant therapies included FLOVENT. On 03-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml (route, lot# and expiration date unknown). On 04-NOV-2016, the patient went to the pharmacy and showed the pharmacist an area of about 3 inches by 8 inches around the injection site that was red and swollen. No treatment was given for the event and no lab was performed. The patient had not recovered from the events at the reporting time. The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
loss of taste(salty taste, coffee) after 10days of 1st dose.  noticed on 4/24 and took PCR test on 4/26 and it was negative
Beginning the next day after the shot, I was tired.  I was extremely tired the 2nd and 3rd days after the vaccine.  Beginning the day after the vaccine, I have noticed that I wake with facial edema each day from 11/2/2021 to today 11/15/2021.
This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 29-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Pt recv vax on 1/20/99; on 1/23/99 pt exp lump in leg, fever (102.3) X 3 day, increased sleep, rolling eyes, pain in arms, hands & legs, staring, screams;dx=ear infection
pt became non-responsive p/vax recvd; gutteral sounds noted w/clonic movements of extremities; lasted momentarily & pt again able to respond; MD says probable vasovagal syncope;
Soft movable lump located over left clavicle. Neck and joint pain on left side felt since vaccine was administered, same as first dose. No visible discoloration, minimal swelling, some heat located at clavicle lump.