chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered expired Daptacel, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that patient was administered expired Daptacel (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 31-Oct-2019, the patient received 4th dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA and expiry date: 23-Oct-2019 via intramuscular route in the right vastus lateralis.  It was a case of actual medication error due to expired vaccine used.  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.
Very mild early symptoms, light soreness for one day. 3 weeks later I began to have some nerve activity in my left shoulder and arm. At times I get a light tingling of nerves at the top area of my left shoulder. I also have nerve tingling on my left arm From my elbow to my left pinky finger. The nerve activity is light tingling of the nerves related to hitting your ?funny bone?. This lower arm activity happens when taking a shower suggesting earth ground activates it? My top shoulder activity happens with no apparent trigger.
I woke up with rash around the vaccine injection site; Irritability within 1 hour of getting the vaccine; Nausea within 1 hour of getting the vaccine; Fatigue within 1 hour of getting the vaccine; The patient received the second dose of vaccination on 25Jun2021; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO198) via an unspecified route of administration in the left arm on 25Jun2021 at 09:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to lactose intolerant. Concomitant medication details were not provided. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO187) via an unspecified route of administration on 09Jun2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 25Jun2021 at 10:30, within 1 hour of getting the vaccine, the patient experienced irritability, nausea and fatigue. On 26Jun2021, the next day (24 hours later), the patient woke up with a rash around the vaccine injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events irritability, nausea and fatigue within 1 hour of getting the vaccine and rash around the vaccine injection site was resolving at the time of this report.
Injection felt like a "knife going into arm"; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Injection felt like a "knife going into arm") and FATIGUE (Fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection felt like a "knife going into arm") and FATIGUE (Fatigue). The patient was treated with VITAMIN B12 NOS for Fatigue, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Injection felt like a "knife going into arm") had not resolved and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Magnetic resonance imaging: normal (normal) Normal. In June 2021, Nerve stimulation test: normal (normal) Normal.         Concomitant medications information was not provided.  Reportedly, the vaccination site pain turned into more of a "tooth ache" pain that has not gone away.
The next day giant red spot on right arm at the injection site lasted 3 days, body aches for  1 day, and possible fever (dint check temp).
Low BP (80/60), diaphoresis, lightheadedness, pallor. Orange juice and granola bar given. 10/31/05 12:05 pm influenza vaccine .5cc administered in left deltoid per standing order. Consent signed. Pt reports "I feel lightheaded," BP taken 80/60, diaphoresis and pallor noted. Pt alert and oriented, answering questions. Granola bar and orange juice given. Paramedics called. 10/31/05 12:10 pm report given to paramedics. Pt stated she gave blood (pleresis) earlier this AM. Pt still conscious drinking juice. State that she is embarrassed  and that paramedics not necessary. Pt states she feels better. Reassured pt paramedics is necessary and PHN wants to ensure that she is alright. 10/31/05 12:15 pm waiting with pt for paramedics. Pt sitting in chair, stable, conscious, answering questions. Pt states she feels lightheaded again and diaphoresing. Paramedics arrived. 10/31/05 12:20 pm Paramedics here. O2 given and VS taken. Pt taken to hospital. Will follow-up with VAERS and pt status. 11/1/05 4:30 pm T/C to pt home. Spoke to pt. Pt states that she is fine, was taken to hospital care ER and was evaluated and sent home stable. No follow up needed.
Skin rash and hyper-pigmentation in the area of the band-aide. Basically a band-aid imprinted rash that burns, very dry. The imprint has not resolved, only increased hyper-pigmentation and raised skin rash.
Moderate chills, moderate to severe joint aches.  Symptoms peaked roughly 12-16 hours after injection, decreasing afterwards.  Symptoms ceased roughly 24 hours after injection.
Patient did not suffer any adverse events known as of yet. However, she did receive a 3rd dose of pfizer covid vaccine after falsely filling out her questionnaire (got first shot else where, came to our location for  the '2' dose series)
Approximately 2 minutes after dose throat felt like it was tightening up really bad. Could still breathe, took Claritin preemptively from similar reaction to the first COVID shot but this was much quicker. Tightening kept happening in waves, felt nauseous, and some itching in mouth and throat. Was still happening while leaving ~45 min after the shot but agreed to let me go home and monitor and keep taking antihistamines and have epi pen just in case I got after my first shot.
100f fever, extremities ache, insomnia, huge pulsing migraine, started night of shot, still going up 27 by later.
Vomiting and nausea began approximately 30 minutes after receiving the vaccine. Extreme nausea continued for one week. Rash occurred one week after receiving vaccine. The nausea continued through week two post vaccine but decreased to a tolerable level with Zofran. Extreme nausea and vomiting returned with the second dose and the nausea continues 10 days post vaccine. I have needed Zofran to stop the vomiting almost every day since receiving the first dose.
Left sided numbness; head pressure; motor skills off; Explosive watery stool; tired; can not keep head up; Eyes feel like they are spinning; This is a spontaneous report from a contactable Other HCP(patient). A 59-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EK9231), intramuscular at Left arm on 13Jan2021 09:30 at single dose for COVID-19 immunization.  Medical history included Diabetes, hypertension, kidney disease, macular degeneration. There was no covid prior vaccination, no Known allergies, no covid tested post vaccination. There were no concomitant medications nor vaccination in four weeks.  The patient experienced Left sided numbness, head pressure, motor skills off. Explosive watery stool, very tired, can not keep head up. Eyes felt like they were spinning, all on 15Jan2021 13:00 with outcome of recovering. There was no treatment.
post herpetic neuralgia; vision problems; balance issues; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender, who was approximately 66 years old at the time of reporting. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 16-NOV-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unknown date, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, post herpetic neuralgia, vision problems and balance issues.  The outcome of the events was unknown. All events were considered to be related to zoster vaccine live (ZOSTAVAX) by the reporter.
3 hours after getting the 1st vaccine, I noticed a loud ringing in my right ear. I then got very dizzy so I laid down. I then got very nauseous. After about another 30-45 minutes later I vomited. I slept for a few hours after that and then did not feel dizzy or nauseous anymore. My left arm was very sore for 3 days. To this day, I still have a loud ringing in my right ear.  .
Light headedness; Fever; Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Weight loss in 2020. Concurrent medical conditions included Blood pressure high since 2015.   In July 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced DIZZINESS (Light headedness), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, DIZZINESS (Light headedness), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of Light headedness, Fever, Headaches, Muscle pain and Joint pain with Humira was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623419 (Patient Link).
Memory loss, fatigue, brain fog, rhinitis, asthma (wheezing, shortness of breath) Arm, neck, and facial pain
Pt. states that after receiving the 3rd Booster of Phizer 10/18/2021, started experiencing symptoms 10/19/2021 02:00am of brain fog, low grade fever, hives, and nausea lasting 3 days. No noted Primary communications.
minor arm soreness; Minor bodyaches; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (minor arm soreness) and PAIN (Minor bodyaches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia (blood work every six months; mutation remains low to zero) since 01-Oct-2014. Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL) from 01-Dec-2014 to an unknown date for CML, AMLODIPINE BESYLATE from 01-Jan-2005 to an unknown date and LOSARTAN POTASSIUM from 31-Aug-2021 to an unknown date for Hypertension.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (minor arm soreness) and PAIN (Minor bodyaches). At the time of the report, PAIN IN EXTREMITY (minor arm soreness) and PAIN (Minor bodyaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-320005, MOD-2021-331218 (Patient Link).
Anaphylaxis  40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and anxiety presents to the emergency department from the vaccine clinic with syncope and allergic reaction.She says shortly after getting her COVID-19 vaccine, she felt lightheaded, had near syncope.   Per bystanders at the clinic, she had a brief episode of unresponsiveness and then spontaneously returned.  She was conversant with multiple members of the code and rapid response team at the bedside. Did initially have some labored breathing but significantly improved.  She had no vomiting but had mild nausea also significant improvement. In the field, IV was established and 125 mg of Solu-Medrol was administered.  She was also given 1 IM dose of epinephrine.  Her symptoms resolved she is at her baseline.  Medically stable for discharge.  Discharge home with short course of steroid, H2 blocker and Benadryl as needed.  Advised patient to follow-up with PCP post discharge.  Resume other home medicationS as listed.   Of note, the patient had a similar reaction with influenza vaccine.
Father reported redness and warmth to the injection site that started on 11/04/20.
Dizziness,dry eyes,dry mouth,vision changes,headaches, depression, anxiety- Sjögrens disease, hydroxychloroquine, eye drops, vitamin d  pain and bump in left breast- Keeping and eye on it, resting muscle
CFS-chronic fatigue synd;extreme fatigue, memory impairment, extreme muscle pain
pt came on friday 2/11 with rash on her left arm saying that she got it after the shot, she tried benadryl and did not help, i called the office of her dr and left a msg for him to call us back to discuss the issue, i also recomended cortisone 10 cream to be applied, when i came back to work on2/15 i called her to follow up she said she is improving and she stopped the cortisone cream after 2 days, and never heard from the  dr office, at the pharmacy the dr did not call back either, i told her to continue on the cream i asked her if something new has happened after this 3rd moderna booster shot  since it is the 3rd dose and unlikely to get side effect specially she did not report anything after the 1st and 2nd dose that she took somewhere else, only today she told us the she got reactions after the second dose back in 4/9/2021 and went to urgent care and told her that this is normal side effects that is why she did not think to mention to us
pt recv vax 5APR99 & exp allergic rxn of itching & redness on back & stomach, duration of 1wk;family physician back a strong possibility it was caused by vax;
Patient came in with  her mom to get their first dose of Covid-19 vaccine. Mom filled out form and selected NO for all questions. After receiving the vaccine, the mom was advised to wait in the pharmacy area for 15 minutes for observation. The patient ended up walking away a few minutes after and fainting face down in of the isles. She came to very quickly but was bleeding from her mouth. She bit her lip and was in discomfort. She was given water and her only complaint was her upper teeth "didn't feel right". She was wearing braces. Paramedics arrived and gave a thorough examination. Mom refused transport to the hospital.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history, co-suspect or concomitant medications was not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot# and expiration date were not reported). No symptoms were reported. No PQC (product quality complaint) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified patient. The patient was vaccinated with the first and second doses of GARDASIL (lot number, dose, route not reported) about one year ago. No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient was in the office to get the third dose. Additional information has been requested.
Narrative: positive covid test after full vaccination, asymptomatic for 1 week after positive test
Patient received Moderna booster on 11/21/21.  The vaccine was administered too high and injected into the bursa.  Patient complains of extreme pain with range of motion of left arm.  No redness or swelling to vaccine site.
Hospitalized 11/12/2021; COVID-19 positive 11/12/2021; fully vaccinated  Discharge Summary  MD (Physician) ? ? General Medicine BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 11/12/2021 Discharge Date: Nov 17, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] COVID-19 virus infection [U07.1] COVID-19 [U07.1] Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] HOSPITAL COURSE: Patient is a 67 YO woman with Hx of COPD (2 L O2 at baseline) who was admitted on 11/12/21 with acute on chronic respiratory failure related to COVID-19 pneumonia. She was also noted to have an AKI felt to be related to poor oral intake and dehydration as it improved readily with IVF. She was treated with PO prednisone and IV remdesivir daily with noted improvement in her work of breathing, supplemental O2 requirements, and inflammatory markers.  She was weaned down to her baseline level of supplemental O2 on 11/15, but was still having fatigue and exertional dyspnea that persisted on 11/16. She and her daughter wanted her to stay through 11/17 to receive a full course of remdesivir prior to discharge.  On 11/17 she was evaluated by both myself and Pulmonary Rehab and deemed stable for discharge home. She was instructed to use 2 Lpm O2 at rest and 3 Lpm O2 with activity (her baseline as an outpatient). She was discharged with a prednisone taper and recommendations to follow-up with her PCP as an outpatient to ensure resolution of her acute illness and hypoxia.
Case number PHEH2012US016528 is an initial spontaneous report received from a pharmacist on 20 Aug 2012, and with a follow up received on 17 Aug 2012. This case refers to an 18-year-old male patient. This patient was vaccinated only with MenCYW component of MENVEO (batch number: X10051) 0.5 ml intramuscularly, in right deltoid on 11 Jul 2012. The liquid component was not mixed with lyophilized A powder component. No adverse event was reported. Follow up report received on 17 Sep 2012. Vaccination site and dose was updated. No adverse event was reported.
At the site of injection, left Deltoid, patient has a red, raised, local reaction.  The affected area is oval in shape and about 3 inches by 2 inches.  Patient reports no other syptoms or problems.  Patient reported to the pharmacy 24 hours after receiving her vaccine.  Patient was instructed to contact her MD for treatment.
Information has been received from a licensed practical nurse (LPN) concerning a 86 year old male with no known drug allergies who on approx 11Oct05 was vaccinated SC in the right arm with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). The LPN reported that on approx 11Oct05. Within 24 hrs of vaccination, the pt developed severe swelling from her shoulder to elbow and a red, hot, painful right arm. Unspecified medical attention was sought and the pt was treated with a antihistamine and antibiotic. At the time of this report, the pt was recovering from her events. The LPN considered the severe swelling from shoulder to elbow and a red, hot, painful right arm to be disabling and other important medical events (OMIC). Additional information has been requested.
On 5/25 pt developed hives on forehead, back, neck, and arms and legs. Pt also had diarrhea for 2 days.  Fussy with Left leg redness around injection site.
Headache and vertigo like symptoms leading to a Blood Clot and left cerebellar infarct (stroke).
The vaccine activated an immune reaction in my left eye where I had previously (10+ years ago) had herpes zoster (shingles) that attacked the cornea. My sight clouded over in that eye prompting me to seek consultation from my eye care specialists.  It was explained to me that it was an immune reaction and not a recurrence of the shingles and was due to the covid vaccine. Steroid and eye pressure control drops were prescribed.  The cloudiness was 90% gone in two weeks.  I am still on low dose steroid and eye pressure control drops are ongoing.
This spontaneous report was received from a nurse refers to 4 patient of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No other concomitant therapies reported. On an unknown date the nurse reported that 4 patients each received a dose (Oka/Merck) VARIVAX that had been exposed to temperatures warmer than the recommended temperatures in the prescribing information (18.1F 22.3F during daily defrost cycles). No adverse effect reported. The outcome of the event was unknown. The causality of the events was unspecified. No PQC involved. Follow-up has been received from the reporting nurse, providing identifiers for the patients. This case refers to a currently 6 years old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was reported. On 20-DEC-2013, at age of 5 years old, the patient received (Oka/Merck) VARIVAX, lot# J004164, expiration date 8-APR-2015, which previously had been exposed to temperatures warmer than the recommended temperatures in the prescribing information. There were no adverse events reported. It was also stated that a new thermometer was placed into the refrigerator and freezer on the first of the year and the reporting nurse was unaware of the defros cycle that occurred prior to the dew thermometer placement. This case is one of several reports from the same reporter. Additional information has been requested.