chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient felt faint and dizzy for a few minutes but she was responsive, she looked pale, but felt better within a few minutes. blood pressure and heart rate was taken. offered to call EMS but mother declined
nurse may have given 3mls instead of 0.5mls of Ipol; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 8 years old patient who received vaccine IPV (VERO) [IPOL] and reported that nurse may have given 3mls instead of 0.5mls of Ipol.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 19-Aug-2019, the patient received a dose of suspect 3 ml IPV (VERO) lot P1A371M and expiry date: 27-Apr-2020 via subcutaneous route in the left arm.  It was a case of actual medication error due to overdose.  It was unknown if the patient had any 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 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.  List of documents held by sender: none.
Information has been received from a licensed practical nurse referring to two patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On 17-NOV-2016, 2 doses of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, subcutaneous, dose not reported) were inadvertently administered to patients for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005166: US-009507513-1612USA005167: US-009507513-1612USA005168.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 63-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 10-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Patient had nose bleeds, loss of urine control, severe leg cramps, nausea, fever 102, body aches, headache within 24 hours of receiving vaccine, she started to fill some better after 24 hours, treated symptoms at home
began having shortness of breath and chest pain in September 2021.  Went to ER and had both lungs with Pulmonary Emboli.  Client had covid virus October 2020.
red spot is a little bit warm; left arm itching around the injection site; red spot about the size of a hardball around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red spot is a little bit warm), VACCINATION SITE PRURITUS (left arm itching around the injection site) and VACCINATION SITE ERYTHEMA (red spot about the size of a hardball around the injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Allergy to ace inhibitors), Drug allergy (Allergy to Zestril), Drug allergy (Allergy to clonidine), Drug allergy (Allergy to codeine), Drug allergy (Allergy to Librium), Drug allergy (Allergy to Adalat), Drug allergy (Allergy to Trental), Drug allergy (Allergy to Cardizem), Allergy to plants (Allergy to belladonna), Drug allergy (Allergy to hydrocortisone), Drug allergy (Allergy to sulfa), Drug allergy (Allergy to Septocaine/epinephrine) and Drug allergy (Allergy to Norvasc (swelling)).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (red spot is a little bit warm), VACCINATION SITE PRURITUS (left arm itching around the injection site) and VACCINATION SITE ERYTHEMA (red spot about the size of a hardball around the injection site). At the time of the report, VACCINATION SITE WARMTH (red spot is a little bit warm), VACCINATION SITE PRURITUS (left arm itching around the injection site) and VACCINATION SITE ERYTHEMA (red spot about the size of a hardball around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient mentioned that she was prescribed a lot of medications, but did not specify any.   No treatment information was provided.
Pt given vaccination one week prior to recommended date.   Pt arrived at clinic,  Filled Vaccination consent with parent signature.  Pt stated they were arriving for second dose of pfizer.  Pt and mother stated they were returning within the appropriate time frame.  After administration of vaccination the RN was given the vaccination card by pt.  This RN observed their vaccination card stated their last vaccination date was 12/03/2021.  The pts consent form did not ask for Pt to enter the date of their last vaccination.   The only verification this RN had prior to administration was the consent of the mother and pt that this pt was returning within the correct time frame.  After observing the card this RN researched within the vaccination tracker, to verify that this card was correct.   This RN began close observation of the pt and escalated this concern to the clinic coordinator.  We educated the pt that they had been given this vaccination earlier than the recommended administration of the second dose.
This 12-year old female was vaccinated with Vivotif (typhoid vaccine live oral Ty21a, Batch no. : unknown). She took the first capsule on 18.Jan.2006, the second capsule on 20.Jan.2006 and third capsule on 22.Jan.2006. One day after intake of the first capsule the patient felt fatigue. After intake of 3rd capsule on 22.Jan.2006 the patient developed skin rash on neck and truck. The patient did not take the fourth capsule. Outcome and treatment of reaction was not reported. This case was forwarded by manufacturer reported. The case was reported as non-serious.
This spontaneous report was received from a pharmacist and refers to a 68 year old female patient who on 06-DEC-2014 was vaccinated with ZOSTAVAX, single dose vial, subcutaneous. No concomitant medications were reported. On 07-DEC-2014, the patient experienced injection site redness, injection site hardness and injection site warmth. The outcome of injection site redness, injection site hardness and injection site warmth was reported as not recovered/not resolved. The patient sought medical attention by going to the pharmacy. No further details were provided. Additional information has been requested.
Pts: mother called on 7-8-08 and reported that pt. has broken out in a rash on her head, face, and trunk. No other s/sx were mentioned. Vaccines were adm. on 7-7-08.
LEFT HAND NUMBNESS; FELT TIRED; ACHY; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: not reported) dose was not reported, administered on 10-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced achy. On 11-APR-2021, the subject experienced felt tired. On 12-APR-2021, the subject experienced left hand numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt tired, and achy, and had not recovered from left hand numbness. This report was non-serious.
Thinks she has start of a sinus infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Thinks she has start of a sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SINUSITIS (Thinks she has start of a sinus infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, SINUSITIS (Thinks she has start of a sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       concomitant medication was not provided.
Seizure, ADD, Autism, face turn blue-white and bubbles out from mouth and jerking.
Sore, swelling and redness - recv'd injection 10-7-14 approx 8 AM - on 10-8-14 showed to administrating RN - swelling up to 3 1/4 inches in diameter still red and tender to touch.
20 mins later my neck, jaw and upper palate were swollen. I took 50 milligrams of Benadryl and 25 milligrams of Pepcid. At midnight my throat was scratchy, and I took 25 milligrams of Benadryl. I've had medical massage and acupuncture and lymphatic drainage. I experienced swelling on my fingers and toes; This continued for 3 weeks. I saw an Allergist on 19 May 2021. A month after the 2nd dose I had minor swelling on fingers and toes. Allergist said there was no common ingredients Shingrix dose 2 and T-dap and analysis showed no common ingredients. Was advised to do booster and resolved 4 weeks later. I had a snake bite 24 Sep 2020 before the 1st dose bite by a copper snake on left arm twice and left foot.
mouth ulcers; stomach ache; rash all over the body; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOUTH ULCERATION (mouth ulcers), ABDOMINAL PAIN UPPER (stomach ache), RASH (rash all over the body) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced MOUTH ULCERATION (mouth ulcers), ABDOMINAL PAIN UPPER (stomach ache), RASH (rash all over the body) and PYREXIA (fever). At the time of the report, MOUTH ULCERATION (mouth ulcers), ABDOMINAL PAIN UPPER (stomach ache), RASH (rash all over the body) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medication was reported.  Treatment details include, steroids and pain medications.
Sudden onset of Autistic features with loss of language milestones after second dose of Hep A vaccine 9/28/15. Patient is here with mom to establish care. He was diagnosed with Autism by group (in Dec 2016 at age 2 9/12). He met all milestones, speaking in complete sentences, until 2 years of age when he stopped speaking. Recent sensory issues with tapping chin with hand, arm flapping, feeding issues. No aggression. Seeking treatment and management for Autism, diet/gut health, supplement management, allergy and food sensitivities evaluation.
Screaming 2 hrs, fussing & crying 5 hrs ( crying not continuous), slight fever, swelling on leg.
Information has been received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On 19-OCT-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L019125, expiration date: 27-MAY-2017, dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Injection area extremely red and warm to the touch. Over the rest of the day the red area continued to get bigger and red area of arm hurts to touch. As of 3/21/15 red area has swelled to 6" x 4". As a norm I take ZYRTEC daily. Began taking BENADRYL on 3/21/15 at 10:15 p.m.
Mother of patient calls health dept to report large local reaction on right arm around site of injection. Child was evaluated in emergency room and given Benadryl and Motrin. Reaction area improved now.
Bexero is FDA licensed for individuals 10-25 years.  The nurse administered the vaccine to a 63 year old man.  No advrse reaction reported at this time
Pt exp fever of 104 w/APAP; Fever was 103 in ER p/APAP;
Difficulty moving extremities; loss of bladder control; tired; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included injection site pain (had injection site pain). Previously administered products included Shingrix (1st dose received on 25th September 2019,refer case US2019AMR230369).   On 14th December 2019, the patient received the 2nd dose of Shingrix. On 14th December 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th December 2019, the patient experienced mobility decreased, urinary incontinence and tiredness. On 15th December 2019, the outcome of the mobility decreased and urinary incontinence were recovered/resolved. On an unknown date, the outcome of the tiredness and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the mobility decreased, urinary incontinence, tiredness and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination with Shingrix, the patient experienced difficulty moving extremities, loss of bladder control, tired and injection site pain. The reporter consented to follow up with physician.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), headache and chills in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever), headache and chills. At the time of the report, pyrexia (fever), headache and chills outcome: unknown/not provided. Concomitant medication and treatment information not reported. It was reported the patient's daughter experienced fever, headache and chills after receiving the second dose of the vaccine. Action taken with mRNA-1273 in response to the event not applicable. Reporter did not allow further contact.
Injection site itchy; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 immunization.     The patient's past medical history included No adverse event (No reported medical history.).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) 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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
started feeling "the reactions"; nose was inflamed like when you have the flu; lost the sense of smell; lost the sense of taste; headache; fatigue; fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste) and COVID-19 (COVID-19) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003T-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever). In September 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste), COVID-19 (COVID-19), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive for COVID-19.     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.   No relevant concomitant medications were reported. Patient received no treatment.; Sender's Comments: This case concerns a 41-year-old, male patient with unknown medical history, who experienced the unexpected non-serious events of vaccination complication, rhinitis, anosmia, ageusia and expected non-serious events of headache, fatigue, pyrexia and covid-19. The events occurred on the 3 days after receiving the first dose of Moderna mRNA-1273 Vaccine. The rechallenge is not applicable as the events reported were only after first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
A teacher  w/hx of varicella on 10FEB97 was exposed to a student who was vaccinated w/1 dose of varicella vax;14FEB97 the exposed pt exp t102;17FEB97 pt devel a rash consisting of at least 50 lesions/vesicles on rt side of face, & leg;
I started having pain in left shoulder. I felt a lump in armpit. I was in so much pain, I went to the Dr. and I was sent to get mammogram and was told that it was a definite lump there. I've had to go back 4 times. Every vaccine shot the pain gets worse. After three mammograms, nothing changed in the lump. This past January the lump looks the same. The issue is that it still hurts. Nothing that they want to do at this time because the lump hasn't changed. Doctor's would like to see if it will clear on it's own.
Patient developed multiple painful nodules over arms, at flu vaccine injection site 3-4 days after receiving Fluzone and maintenance allergy immunotherapy injections.  She was diagnosed with erythema nodosum by clinical presentation and skin biopsy.  She was not prescribed any therapy.
A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
pt very lethargic, must lay down, achy, mild fever low grade;went to walk in clinic had blood work drawn showing low white count;no rash;may have mono 8SEP97;poss fighting flu;reports rash raised & itchy;poss allerg to PCN;
Broke out in rash on 8/18/09, seen in ER with increased rash, T - 102 degrees on 8/19/09.  Started on PREDNISIONE.  Phone call from mom on 8-21-09 states T decreased, but continues to break out in rash.  Has blisters on inside of mouth.  8-24-09 client seen by PMD.  On 8/21/09 put on more med - unknown type, told to not continue series of vaccine.
Ringing in left ear began afternoon of shot Oct 6. Woke up Oct 7 and couldn't hear in left ear. Primary told me to go to a HCF. They told me to wait 5 days and then contact a local ENT.
Received first vaccination on Feb. 4, noted decreased activity approximately 3-4 days after receiving vaccination. As time went on begin to stay in the bed more and more. Complaint feeling tire and unable to walk short distance without getting out of breath. Decreased strength and increased fatigue. Feb. 25 received second vaccination approximated 3-4 days after receiving vaccine, became very unbalanced, and falling. became  short of breath while without any  activity. Went to physician on 03/04/2021 Hemoglobin 7.5 was hospitalized had to receive multiple blood transfusion.
L upper arm swollen, reddened after patchy non-raised rash.  Painful arm. L forearm and L side feels like a stiff neck.  Has headache.  Received VACC.  on 10/27- no problem.  Sore arm on 10/28.  More painful on 10/29 and also involving neck + forearm, plus rash + swelling, headache.  On 10/30/08 had generalized malaise, chills, fatigue.  L Deltoid, trapezius sore + HA present.  Still has neck + trapezius muscular stiffness + pain and also headache as of 10/31/08.  Taking PREDNISONE dose pack and BENADRYL.  Physician dx'd localized allergic reaction.