chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No patient side effects; expired vaccine administered; This spontaneous report has been received from a certified medical assistant concerning a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, and concomitant medications were not reported.  On 23-JUL-2021, the patient was vaccinated with an expired dose haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, lot # R027322, expiration date 09-JUL-2021, administered intramuscularly x 1 dose, for prophylaxis. The caller confirmed that expired vaccine has had no temperature excursions; also, per post expiry memo, the reporter informed that expired vaccine potency was supported, and re-administration is up to the healthcare provider. No reported patient side effects. No other information was provided.
Patient received her HPV and passed out; remained in office for several hours due to dizziness; extreme fatigue. These symptoms persisted once she left the office. She returned to the office with persistent dizziness and fatigue 6 days later. Denies fever, vomiting. Had been nauseated from the time she fainted through those 6 days, no vomiting, no viral symptoms
Pt had no adverse reactions with imms. Pt admitted to hosp on 9/30/05 for croup x 24 hrs.
marked weakness and inability to walk without assistance.  Very unstable. Has fallen several times.  These symptoms are much more pronounced than before the vaccine was given.
Fainted/ sweats while walking to car. Recovered, but became very light headed in car and reclined seat to avoid losing consciousness ( was not driver).
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 29-JUN-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA002267: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Presents to the ED c/o SOB for 2-3 days.  According to EMS, pt was 50% on RA that went up to 70% on O2. Associated sx include cough and congestion  asthma, paroxysmal atrial fibrillation, hypertension, obstructive sleep apnea.  Sars cov 2 Detected.  diagnosed of Covid-19 pneumonia.  Tx.  IV steroids On high-flow oxygen.
Patient started experiencing lightheadedness 30 seconds after injection.  We had him sit down and at that time he became less responsive and his eyes rolled back in his head but he remained upright but not very responsive.  Called 911 and attempted to check for breathing  and pulse.  He had both and shook his shoulder trying  to get him to respond.  He responded very incoherently with eyes closed.  Attached blood pressure cuff and pulse oximeter to monitor vitals.  BP at 12:35 was 76/53 pulse 72 and 93% O2 Sat.  12:38 78/53 12:40 96/69 Patient speaking and feeling some better.  12:41 106/77 pulse 71  O2 Sat 95.  12:44 160/98  Pulse 78 12:46 155/25 Pulse 93
3 inches x 3 inches very inflamed red, hot and painful. 2 days after vaccines. Advised OTC products and if gets worse patient is going to urgent care of ER.
A consumer reported she obtained information from the internet concerning a 15 year old female consumer hypersensitive to allergens, who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and Lot # not reported). Concomitant therapy included ORTHO TRI-CYCLEN LO. On an unspecified date the patient developed itching and urtica of feet and hands. It was unspecified if the patient sought medical attention. It was reported the events were serious with persisting consequences. At the time of the report, the patient's outcome was unknown. Upon internal review itching and urtica of feet and hands were considered to be an other important medical events. This is one of several reports from the same source. No further information is available.
Mom states pt swollen red lt upper arm starting tues 23APR91 + fever 102-103 starting 23APR also; rx w/cold then warm soaks + APAP q 4 rhs; 25APR91 to ER dx cellulitis lt arm;
In August 2021, I started having heart palpations about 6 months after my second dose of Moderna vaccine.  I had never had these palpitations before the vaccine, but I have no reason to believe the two are necessarily connected.  In February 2022, I was diagnosed with Afib after the palpitations continued to grow in timing and strength.  I'm now on medication which seems to control the condition.
Patient administered Zostavax 6/22/07 Developed herpetic lesions along L2 dermatome noted 7/12/07. Only 2 face of group lesions already scabbed, no pain
5/10/21 - I began to urinate uncontrollably for 20 minutes and off an on during the night and early morning. 5/11/21 - At 1:45 p.m., I noticed a rash on my left upper thigh (quadracept).  This rash disappeared within 30 minutes of discovery. 5/11/21 - From 2:00 p.m. to 2:15 p.m. I had a fever.  I had the shot at the pharmacy on 05/10/21.
No reactions occurred. Vaccine administered on 4-28-22, however due to it being kept in fridge it should have expired on 4-8-22, therefore pt received expired vaccine.
someone in the family had quite reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (someone in the family had quite reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (someone in the family had quite reaction). At the time of the report, VACCINATION COMPLICATION (someone in the family had quite reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant and treatment medications were reported.    Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: None" (unspecified if ongoing), notes: Other medical history: None. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5 cm x 6 cm faint erythema with swelling and mild tenderness. Full strength and normal sensation in both arms.
Limited rotation with pain, cant sleep on left arm without waking up in pain, shoulder joint occasionally pops
Patient reported a petechial rash with pruritus starting the morning after vaccine administration. and more  prominent on right leg.
red, round, slightly raised, tender to touch area at the injection site; red, round, slightly raised area at the injection site; round, slightly raised, tender to touch area at the injection site; Adacel was vaccinated to 73 years old patient; red, round, slightly raised area at the injection site; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a consumer (patient) or non-health care professional.  This case involves a 73-years-old female patient who experienced red, round, slightly raised, tender to touch area at the injection site (vaccination site inflammation, vaccination site erythema, vaccination site swelling and vaccination site pain), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 04-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious red, round, slightly raised, tender to touch area at the injection site (vaccination site inflammation, vaccination site erythema, vaccination site swelling and vaccination site pain) unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was a case of an actual medication error case due to inappropriate age at vaccine administration.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.
This spontaneous case, was received from Other-Non Health Professional on 05-Oct-2017, concerning a 44-year-old, adult, male patient. The patient's concomitant medications included: Metoprolol. Patient's medical history included: fatty liver, chemotherapy in 2006 and hypoglycaemia. On 09-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: upper arm (reported as upper muscle arm), batch number, expiry date: not reported). On the same day, the patient experienced malaise a few minutes after receiving the vaccine. On 28-Sep-2017, patient experienced collapsing, shivering, fever, loose stools, stomach pain, headache and felt like his head was going to explode. At the time of this report, the patient had not yet recovered from the event (patient feels "kind of funny", symptoms come and go). The reporter assessed the events as non-serious. Follow-up received on 18-Oct-2017: Age of the patient was updated to 44-year. Anatomical location and route of administration was updated. At the time of this report, the patient had not yet recovered from the events (reported as symptoms come and go). Narrative amended accordingly. Significant case correction received 05-Oct-2017: The company causality of the event 'diarrhoea' was corrected from not reported to not related. Significant case correction received 05-Oct-2017: As Determined Listedness of the event headache was changed from unlisted to listed flu vaccine cell subunit NVD.
tinnitus.  Please note I do not know the exact day it started - he just said "after" the vaccine, but I couldn't complete the form without putting in a date. Patient reports the tinnitus has not resolved since then.
After patient had immunization they were taken to check out and asked to wait in the lobby for 15-20 mins. After being in the lobby a few mins mom noticed that patient became pale and sweaty. Mom notified front desk staff and nurse went to lobby and brought patient back to clinical area. BP checked every 3 mins X 3 and patient was given some coke and peanut butter crackers and cool cloth was placed on patients forehead and neck area. After about 5-6 mins patient began to feel better and color returned to skin. BP @ 3:50 pm- 79/47 P-90; BP @ 3:53 pm- 107/64 P-108; BP @ 3:56pm- 99/72 P-101. Patient was released back to lobby and advised mom to wait an additional 15 mins.
Rash on trunk, chest and back. non pruritic. slightly raised. Rash onset approx 48 hrs after vaccinated. No fever or myalgias.
Dizziness, profuse sweating, felt hot,shortness of breath, felt like passing out, vision disturbance (saw black spots) , weakness. This occurred immediately after shot was given. Medical personnel  moved him to area to monitor his vitals, gave him ice packs, checked blood pressure, heart rate etc.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Muscle spasms which are appearing about every 5-10 minutes in my upper arm and below my shoulder blade towards my back. And the spasms last for a few min, and are in bursts of 6-8 at a time back to back.
1st symptom was red spot at site for 4 days with frequent bowel movement resolved after 4 days. 2nd symptoms was lesions on roof of mouth that started 4 days after 1 or 2 and continued until time of report. PATIENT hAs follow-up appt. on 3/9/20 to assess the unresolved oral lesions on roof of mouth.
The adverse reaction did not occur until two weeks after my Moderna vaccine. The night before, I noticed hives on my throat and swollen lymph nodes in the neck. Throughout the night, I felt burning and scratching on neck and face. Next morning, when I woke face was swollen up like a balloon so that I could not open my eyes, I did manage to see out of a slit in my right eye. (I do not get reactions like this). Lymph nodes in neck were visibly sticking out. Later on, my throat was somewhat closed (this was not recorded, it happened during the day after my appointment).
This case was reported by a nurse and described the occurrence of inappropriate age at vaccination in a 4-month-old male patient who received KINRIX (batch number AC20B221BC, expiry date 25th October 2014). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to KINRIX. Additional information: A dose of KINRIX was inadvertently administered to a 4 month old patient. Meanwhile KINRIX was recommended for children between 4 to 6 years. No adverse event was reported.
Right thigh has a raised, red, warm knot. Growing in size. Pt. seen by the provider and given antihistamines and told to follow up if no better.
Redness and Itching. Benadryl 3-4 days. Upper arm pain, throbbing, radiating to elbow and hand. Weakness, sore to touch, trouble sleeping due to pain. 11/08/2010- current (12/26/2010)
The nurse is reporting that unknown number of patients received improperly stored V ARlV AX since 7/25/2021; No further information is available; wrong route of administration; This spontaneous report as received from a nurse referring to an unknown number of patients of unknown age and gender.The patients' medical history, concomitant medications, drug allergies, or reactions were not reported.  On 25-JUL-2021, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 that has been verified to be valid, expiration date 23-JAN-2022, for prophylaxis (dose, frequency, strength, and route of administration, were not reported). The vaccine was expose to a temperature of 37.94 Fahrenheit degrees for 100 hours, no previously temperature excursion were reported (product storage error). No additional adverse events were reported.  Follow-up information was received from a nurse on 20-SEP-2021. This case was previously non-valid due to the lack of patient's identifier. The patient was 4-year-old male. On 03-AUG-2021, the patient vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) intramuscularly (Drug administered via inappropriate route), in the left tigh, lot number: T002847, expiration date: 23-JAN-2021. The digital data logger was involved. The varicella virus vaccine live (oka/merck)(VARIVAX) was removed immediately after contacting the company. Parent were being notified and this dose of varicella virus vaccine live (oka/merck)(VARIVAX) would be repeated with new vaccine stock.; Sender's Comments:  US-009507513-2109USA005394:
Anxious; Nervous; Itchy eyes; large rash at the site of the injection measuring 3 by 6 inches in length; red (rash); This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxious), NERVOUSNESS (Nervous), EYE PRURITUS (Itchy eyes), VACCINATION SITE RASH (large rash at the site of the injection measuring 3 by 6 inches in length) and RASH ERYTHEMATOUS (red (rash)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic shock.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE RASH (large rash at the site of the injection measuring 3 by 6 inches in length) and RASH ERYTHEMATOUS (red (rash)). On an unknown date, the patient experienced ANXIETY (Anxious), NERVOUSNESS (Nervous) and EYE PRURITUS (Itchy eyes). At the time of the report, ANXIETY (Anxious), NERVOUSNESS (Nervous), EYE PRURITUS (Itchy eyes), VACCINATION SITE RASH (large rash at the site of the injection measuring 3 by 6 inches in length) and RASH ERYTHEMATOUS (red (rash)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Hospitalized with severe brteathing problems and chest pains. Diagnosed as aspirational pneumonia. Chest pain (slight) remains today
Mother called 12/29/2006 to report that her daughter had redness and a hard knot at the site of injection for the Hib and Prevnar, L Leg. Mother was advised to use warm compress, give Tylenol, Benadryl, and observe the child for increased swelling, redness, and if desired, could bring child to the health department that the nurse could observe the leg.
Anxious; shortness of breath; soreness at the ejection site; headache; other vaccine same date product= Pfizer Flu shot; other vaccine same date product= Pfizer Flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 11:30 (Lot number: FF8839) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Nsaids, reaction(s): "Known allergies: NSAIDS", notes: Allergies: NSAIDS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 08Feb2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 27Oct2021, outcome "unknown" and all described as "other vaccine same date product= Pfizer Flu shot"; ANXIETY (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "Anxious"; DYSPNOEA (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "shortness of breath"; VACCINATION SITE PAIN (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "soreness at the ejection site"; HEADACHE (non-serious) with onset 27Oct2021 13:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of anxiety, dyspnoea, vaccination site pain, headache.  Additional information: Facility type vaccine was Workplace clinic, facility country was reported. Other vaccine was received in four weeks. Other vaccine 4weeks product include Pfizer Flu Vaccine with vaccination date 27Oct2021, lot number Unknown, dose number 1 in left arm. No other medications were taken in two weeks. Adverse events began roughly 1-2 hours following injection. Symptoms worsened the next morning. adverse event start date: 27Oct2021 & time was 01:00 PM. Patient not recovered. No treatment received. No covid prior vaccination. No covid tested post vaccination. I am the patient and the symptoms/awareness date was 27Oct2021. Patient reported the symptoms/awareness date as 27Oct2021.  Follow-up attempts are completed. No further information is expected.
The vaccine was administered on Tuesday morning and the patient started having signs of a fever blisters. The patient states they have a history of fever blisters when stressed and had an outbreak the following day, Wednesday (9/8). As this report is being submitted on Saturday (9/11), the patient's symptoms have spread from their upper lip to the side of their side burn. The patient shows no sign of blockage of airways and can breath and is experiencing erythema on the face. I have suggested the patient to try an antihistamine but if symptoms persist to check with their doctor for further treatment.