chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient never received the 5th dose, with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from other health professional and consumer/ non-healthcare professional via Media Information (under reference 00787054).   This case involves a 7 years old patient (unknown gender) who never received the 5th dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) [product dose omission issue].  The patient had received DAPTACEL for the first four dose in the past.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DAPTACEL (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Missed dose (same day latency).  It was reported "Is it okay to give them ADACEL for the 5th dose? A clinic wanting to know how to help get a consumer caught up due to having a 7-year old that has not gotten their 5th dose of DAPTACEL. The caller reported that the last dose of DAPTACEL was at the age of 4-years-old."  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. 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 lot number for this case.
12/13/2022 at bedtime, I felt like I had a lot of drainage down my throat and felt funky. I woke up the next morning with a sore throat and continued to feel like I had drainage in my throat. I also felt lethargic. I took a home COVID test and saw a faint line. I went to a walk in clinic, and my COVID test was negative. The doctor heard rails in my lung and saw fluid in my ears. She thought I may be recovering from COVID even though I tested negative. She prescribed an antibiotic, doxycycline, and told me to take MUCINEX for a week. On 12/15/22, I took a home COVID test and it was positive. The sore throat went away by that point, and I had congestion in my chest and a few days later congestion in my head. I have continued on the antibiotic and MUCINEX. Today, I feel a lot better, but still have congestion, lethargy and began sneezing yesterday a lot. I have not recovered even though I do feel better.
Colitis and antibiotics. Ovarian vein Thrombosis, blood thinner.
BUD date excursion, BUD was 4-7-23 and vaccine administered. 4-22-23
22-24 hours after the shot I got a massive headache that lasted from 3pm to 10am the next morning.  I then noticed ringing in my ears that I didn't fully identify or notice for about a week but am not able to track it back to anything else. I also on February 4th while flying home from a business trip, had shooting pain in my right ear and above my eye that even when I had sinus issues in the past it was never like this. The pain was so severe that upon landing I went directly to my doctor who checked my blood pressure, ears, etc.. but could find nothing.  The ringing in my ears has gotten progressively worse on some days and then others less severe. I have researched tinnitus and tried remedies as well as have been back to my doctor but we are not finding any other issue that may be causing it. Upon an article that came up on adverse reactions to the booster, we saw that ringing in the ears is a possible side effect.  As we can not find any other root cause, I am reporting this so that you have the data to mitigate this in the future.  I had no adverse affects to my first two Maderna vaccine shots.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patient's medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # K012457 with expiration date of 04-JUN-2017, lot # K012456 with expiration date of 28-APR-2017, lot# J005010 with unspecified expiration date, lot #K002831 with unspecified expiration date) (strength, dose and route unknown). No adverse effects reported. No product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the muscle group was sore. The next morning I was dizzy, lightheaded, mild headache, nausea, chills. It went all throughout the day. I just drank some clear liquids and ate some soup. When I woke up the next day about 36 hours after receiving the vaccine I had low energy, nauseous, and lightheaded . By that night my arm started feeling weird, it had a tinging feeling, I went to look at it the mirror and there was a red area and bumps but  it was lower under the injection site. It seemed to get worse, swelling and more rash so I took Loratadine 10 MG (antihistamine). I went to bed and when I woke up this morning the rash was gone but the soreness is still there and the tinging feeling in my arm is still there. It feels like when your arm falls asleep.  I tried to called my doctor but their phones are down and I will try reach back out this afternoon.
(L) upper arm pain every morning since had PREVNAR 13 vaccine requiring Ibuprofen.
itching; rash; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received the first dose of bnt162b2 (Pfizer/BioNTech COVID-19 Vaccine), via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated she received the 1st dose of the Pfizer Covid vaccine on 18Mar2021, and had been complaining of itching and rash. She has contacted her HCP who has advised her to take Tylenol for itching. Patient wanted to reschedule her 2nd dose of the vaccine until the itching is resolved. The outcome of the events was not reported.  No follow-up information needed. Information on the lot/batch number has been requested.
Pt recvd 2nd Hep B vax 14NOV90 & on 28NOV90 & exp fever,nausea,h/a,aching muscles,flu-like sx.Tx w/ ADAP & phenergan. Later, liver enzymes stabilized & returned to normal.
ADMITTED TO HOSPITAL ON 5/20/22 WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING; ALSO HAS COUGH AND MILD DYSPNEA. HYPOXIC AFTER ADMISSION.  UNKNOWN WHEN PATIENT WAS DISCHARGED FROM HOSPITAL PRIOR TO DEATH.  CAUSE OF DEATH ON DEATH CERTIFICATE LISTED AS - SMALL BOWEL OBSTRUCTION, ACUTE KIDNEY FAILURE, COVID-19, HYPERTENSIVE CARDIOVASCULAR DISEASE, AND DIABETES.
Pt was admitted on 8/19 for a nonhealing diabetic foot wound. On 8/25 he was tested for COVID due to his wife being a visitor and testing positive for COVID at hospitalized at an outside facility with COVID-pneumonia. He was found to be positive, but asymptomatic.
Headache & Myalgia Narrative: missed work following second dose due to the above symptoms
HCP called to report that on July 3rd 2023, a 58-year-old patient was administered a dose of 0.5mls of VAQTA Lot:X004813 Exp: 7/28/2024. Patient is currently undergoing treatment for HEP. C. Patient began treatment for Hep. C recently and this was af; Patient is currently undergoing treatment for HEP. C. Patient began treatment for Hep. C and this was after the dose of pediatric VAQTA 0.5ml was given; This spontaneous report has been received from a medical assistant, regarding a 58-years-old patient of unknow gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 03-JUL-2023, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, at a pediatric dose of 0.5 milliliters intramuscularly as prophylaxis (lot number: X004813, which was determined to be valid as syringe formulation, with an expiration date on 28-JUL-2024) (strength and anatomical location of administration were not reported) (Incorrect dose administered).  It was stated that on an unspecified date on 2023 (reported as currently), the patient started treatment for Hepatitis C. No additional information has reported. The outcome of hepatitis C was not provided.   The causal relationship between Hepatitis C and Hepatitis A Vaccine, Inactivated (VAQTA) was not reported.  Upon internal review, the event Hepatitis C was determined to be medically significant.
Patient fainted, was out for about 10-15 seconds.  When she came to she knew where she was as well as the day.  She appeared  sweating and pale at  first, a few minutes later after have some water and gatorade her appearance  was back to normal
Pt recvd vax 17JAN92 & on 26JAN92 devel dermatitis involving 1-2mm intradermal nodules over lt forearm (site of administration) & on chin;
Rash at site erythematous, 10 day after vaccination, no systemic symptoms other than fever other siblings w/ fever and wild sx.
I lost my hearing in my left ear and got tinnitus. I started having vertigo episodes. I blacked out and ended up in the hospital. Doctor put be on diuretic and nausea pills.
This spontaneous report was received from a 60 year old male physician (also the patient) via company representative. The patient's medical history included episodes of shingles and Bell's Palsy in the past years (dates unspecified). On an unknown date in November 2015, the physician who is also the patient was vaccinated with ZOSTAVAX (dosage information, therapy route and lot number were not reported) for vaccination. Concomitant medications were not reported. On an unknown date in March 2016, the patient started showing signs of Bell's Palsy. The patient could not blink the left eye and hence a patch was placed over left eye to protect the eye. On an unknown date, the patient received unspecified antivirals and steroids as treatment. The patient sought medical attention by visiting physician's office. The reporter stated that there was intervention done to prevent serious criteria (details reported as Patch over left eye to protect eye because he could not blink). The outcome of Bell's Palsy was unknown. Causality assessment was not provided. No other information was available. Upon internal review the event "Bell's Palsy" was determined to be medically significant. Additional information has been requested.
Injection given per above description and immediately patient fainted with seizure-like episode that lasted seconds. Sleepy after event and pale but Fully recovered later.
In May of 2022 outbreak of psoriasis of the scalp and mildly on other body part causing me to see family physician followed up my specialist for dermatology. Diagnosis of general psoriasis with current treatment of medicated shampoo as well as topical solution for itching and pain.
3 immunizations given in right arm, 2 immunizations given in left arm, patient had syncopal episode. Diaphoretic, and patient complained of dizziness and slight nausea; Oxygenation 98%, BP monitored q 5-10 minutes 88/60-110/60, pulse monitored q 5-10 minutes 58-60 BPM, Respirations 12-16 per minute. Patient stated he had not eaten any breakfast prior to appointment, given juice and water. Legs elevated and cold compress to neck
tongue swelled up on left side , completely; nausea; trouble breathing/very winded when I climbed the stairs; heavy chest; felt like I had been punched in chest; arm swelling; chills; headache; felt exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), SWOLLEN TONGUE (tongue swelled up on left side , completely) and PERIPHERAL SWELLING (arm swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), PERIPHERAL SWELLING (arm swelling), CHILLS (chills), HEADACHE (headache) and FATIGUE (felt exhausted). On 25-Apr-2021, the patient experienced NAUSEA (nausea). On 26-Apr-2021, the patient experienced SWOLLEN TONGUE (tongue swelled up on left side , completely). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-Apr-2021, HEADACHE (headache) had resolved. On 26-Apr-2021, PERIPHERAL SWELLING (arm swelling) had resolved. On 28-Apr-2021, SWOLLEN TONGUE (tongue swelled up on left side , completely) and NAUSEA (nausea) had resolved. On 30-Apr-2021, DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), CHILLS (chills) and FATIGUE (felt exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-Significant followup Email Received- nonsafety info.
Information has been received from a pharmacist concerning an about 67 year old female who on 19-JAN-2008 was vaccinated SC in the right upper arm with a single dose of Zostavax (Oka/Merck).  On approximately 19-JAN-2008 the patient developed an "itchy irritation" at the injection site.  The patient sought medical attention by calling the pharmacist.  There were no lab studies performed.  On 23-JAN-2008 the patient recovered from itching nad swelling. There was no product quality complaint involved.  No further information was provided.  Additional information is not expected.
Patient came in verbalizing he had not received a previous Moderna vaccination.  Upon receiving what was believed to be the first dose of Moderna, the query within EHR completed and it showed that he previously received a J&J vaccine.  When questioned he seemed confused, but did acknowledge that he did receive a J&J previously (from kaiser).  To clarify, he received a full dose of Moderna after receiving a full dose of J&J.  This was before any booster approval available for covid vaccines.
Information has been received from a healthcare worker concerning a 61 year old male with a history of lymphoma with no drug reactions/allergies who on 16-JUL-2007 was vaccinated with PNEUMOVAX 23 (lot # unknown) at another physician office practice.  On an unspecified date the patient developed redness and soreness at the injection site.  Medical attention was sought.  The patient will be following up with his primary care physician.  At the time of reporting the patient has not recovered.  Additional information has been requested.
After vaccine patient was laughing and less than one minutes she fell on the floor said she was dizzy. Sat down took BP and waited 10 mins. and recovered.
Hives, tingling in fingers, toes and on my tongue, fast heart rate, severe fatigue, headache
After HPV vaccine was administered on the left deltoid, patient stated " Oh my God" and she dropped her head to the left side. Patient bended both arms with close fist and had rapid jerking movements for few seconds. Patient was sitting on the chair. Patient was not responding  when mother was calling her. Dr. was called and came inside the room immediately for evaluation. When the doctor came into the room, the patient was making eye contact with the doctor but not speaking and could not tell the doctor where she was. About 30 seconds later, she stated  her name and her age, and mental status returned to baseline. Patient  was tearing up and shivering. Vitals were taken and normal. Dr. determined to be stable and patient had some water. Patient was monitored for 1 hour. After that time, patient left in stable condition. Patient was ambulating in company of her mother. Pediatrician consulted neurology  took who recommended f/u with neurology, who would likely do a workup including EEG and EKG.
20X14 cm pink firm macule on left arm, redness with edema and tender.
Client presented at immunization clinic at 0928am for a meningococcal vaccine required for college. Client stated that she had never received the vaccine previously. Client was given the Menactra vaccine at 0945am. After administration and while entering vaccine information into the county record system (M&M) and the NCIR it was noted that the client had received the Menactra vaccine previously on 06/27/2007. Client and parent was immediately informed of error and CDC was notified -call reference # 1-62191992 at 0954am. Client left clinic having no symtpoms of adverse reaction and phone number was taken to follow up with client with CDC recommendations. CDC recommendations were relayed to client at 1009am via telephone call. Client was informed to contact PMD or EMS for adverse reactions and then to please report to VAERS and to health center. Client verbalized understanding.
Cough; Severe sore throat; Bodyaches; Sneezing; Lightheaded; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration on left arm on 13Mar2021 at 12:00 as a single for COVID-19 immunisation. Medical history reported as none. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19 On 14Mar2021 at 00:00, the patient experienced cough, sneezing, lightheaded, severe sore throat, body aches, fever and fatigue. No therapeutic measures were taken for the events. The clinical outcome for the events of cough, sneezing, lightheaded, severe sore throat, body aches, fever and fatigue was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Ipsilateral left arm swelling and erythema encompassing from mid-arm to mid-forearm (including elbow joint but with full range of motion), starting 1 day after vaccine administration. Reaction noted at visit today.
Redness to right upper arm 2 1/2 cm x 2 cm and approx 1 1/4 cm induration. Prescribed Omnicef 125/5 3 ml BID x 10 Days.
Atrial Fibrillation diagnosed 06/23/2021; currently being treated medically ; cardioversion scheduled 10/26/2021
I had my vaccination on 04/25/2021. Immediately after I started to get dizzy. They kept me there for 30+ minutes as they monitored me. They gave me juice and water. The dizziness lasted for about an hour. The dizziness came and went over the next few days.
Pt indicates that she feels that experienced side effects after administration of 2nd dose of SHINGRIX. Patient says she experienced headache, chills, fever, and body aches.
lymphadenopathy, left armpit. Treated with alternating warm and cold compresses every 30 min, and 400mg Ibuprofen, every 6 hours as needed for pain.
COLD; TIREDNESS/ FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for prophylactic. On an unspecified date, the subject experienced cold, and tiredness/ fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness/ fatigue and cold was not reported. This report was non-serious.
Of note I have a history of Mild- Asthma, resuce use only as needed. Abouy 4 hours after my second dose  of teh Pfizer vaccine i noticed i was having chest/ lung tightness. By that evening the chest/ lung tightness was more notibale and bother sum I could not go fo my nightly 1 mile run.  That same night I work up and needed t ouse my recuse due to chest/ lung tightness. chest/ lung tightness contiuned on for nearly 3 weeks. I had to carry my resue inhaler, and use if I was doing anything strinuas, Like fast past walking, climing stairs, Carrying in groceries. I would not run at night with out stopping every couple houndred yard and trying to recoop by breath.
Adverse events: Fast and racing heartbeat, elevated temperature, pressure in head, light headed, fatigue and general and blurred vision.
pt recv vax 18DEC96 & on 25DEC96 pt devel soft tissue swelling in lt clavicle joint, arthralgia in lt shoulder & an inflammatory lymphangitic mass on lt chest;pt hosp on 6JAN97;
Dizziness /of passing out that she had to lay down; Fever; After administration of vaccine, a patient experienced injection site Redness, Swelling, Warmth and Pain.; Redness at injection site; Swelling at injection site; Warmth at injection site; Pain at injection site; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 54 years old female patient who experienced injection site redness, swelling, warmth and pain (vaccination site inflammation), redness at injection site (vaccination site erythema), swelling at injection site (vaccination site swelling), warmth at injection site (vaccination site warmth),pain at injection site (vaccination site pain), dizziness /of passing out that she had to lay down (dizziness) and fever (pyrexia), while she received vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) [MENVEO].  medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Jul-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 26-Jul-2019, the patient received a 0.5 ml dose of suspect MENVEO (Solution for injection) not produced by Sanofi Pasteur lot AMVAO 54A (Expiry date 30-Nov-2019) via intramuscular route in unknown administration site for Prophylactic vaccination.  In Jul-2019, the patient developed a non-serious injection site redness, swelling, warmth and pain (vaccination site inflammation), redness at injection site (vaccination site erythema), swelling at injection site (vaccination site swelling), warmth at injection site (vaccination site warmth) and pain at injection site (vaccination site pain) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENVEO.  On 26-Jul-2019, the patient developed a non-serious dizziness /of passing out that she had to lay down (dizziness) and fever (pyrexia) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENVEO.  Details of laboratory data were not reported.  Final diagnosis was Vaccination site inflammation, Vaccination site erythema, Vaccination site Swelling, Vaccination site Warmth, Vaccination site Pain, Dizziness and Fever.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered from Dizziness and Fever and Not Recovered from Vaccination site inflammation.
Myalgia, SkinRash, Rash, UrticariaPruritus, Swelling