chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with allergy to penicillin and no pertinent medical history. On 30-APR-2013 the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # H020683, exp. date: 15-FEB-2014). There was no concomitant medication. Within 24 hours of receiving ZOSTAVAX, on approximately 30-APR-2013, the patient developed an injection site reaction. The area was raised and hot to the touch and radiated past the patient's elbow. No rash reported. Therapies with ibuprofen and BENADRYL were given for the events. No lab diagnostics studies were performed. The pharmacist spoke to the patient yesterday (on 05-MAY-2013) who said that the area was improving. At time of report, the outcome of the events was reported as recovering. Additional information has been requested.
HURT; COULDN'T FOCUS; COULDN'T LIFT A STEP; SHUFFLING; THROAT CLEARING; SINUSES; CHILLS; EXHAUSTED; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hurt, couldn't focus, couldn't lift a step, shuffling, throat clearing, sinuses, chills, exhausted, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, exhausted, nausea, hurt, couldn't focus, shuffling, throat clearing, couldn't lift a step and sinuses was not reported. This report was non-serious.
pt recv vax 30AUG95 & on 2MAY97 pt exp a rash w/18 lesions;
Weakness; CHILLS; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (CHILLS) and PYREXIA (Fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Asthma (Intermittent asthma), Allergic rhinitis, UTI (Patient has history of frequent UTIs) and Migraine (Patient states that they have frequent migraines at baseline.). Concomitant products included TELMISARTAN and HCTZ for Blood pressure management, GABAPENTIN for Headache, ALLOPURINOL, MONTELUKAST, PANTOPRAZOLE and POTASSIUM for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (Weakness), CHILLS (CHILLS) and PYREXIA (Fever). The patient was treated with BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, ASTHENIA (Weakness), CHILLS (CHILLS) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication also included two antibiotics  The patient reported a weeklong after the second immunization then sporadic, weakness in body, the shot might be exacerbated that, fever, and chills.   This case was linked to MOD-2021-114295 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up was received. Updated patient demographics. Added Medical history. Added additional concomitant medications.
Nausea, HA, chest tightness, metallic taste in mouth, throat closing.
in the day or two following the shot, the arm was stiff and tender/sore when moved or rolled over on;  nothing was visible on skin or at injection site;  this gradually abated over the next few days.  On day 9, the area around the injection site became red and inflamed (approx 3-4" in diameter).  it is hot to the touch, feels "hard" and occasionally feels like it might itch.    The skin is otherwise smooth in appearance/to the touch.  No blistering or excretion.  I have applied over the counter cortisone cream a few times.  On day 10 (today) the redness seems to have faded a bit  - but otherwise unchanged.
Patient admitted to the hospital testing COVID positive  and with a GI bleed (has a hx. of chronic duodenal ulcers and was on an anticoagulant)
PATIENT C/O FEELING VERY WEAK THE MORNING AFTER HER VACCINE.  LASTED ABOUT 8 HOURS.  DENIED ANY OTHER ABNORMAL SYMPTOMS.
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 56-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 24 years old female patient. The patient's history of previous pregnancies and live births was not known. The reporter stated that the patient had hepatitis B series(manufacture unknown) when she was young, but a titer was drawn and she did not seroconvert. Nurse stated the client was in nursing school, so she was given a dose of RECOMBIVAX HB on 21-AUG-2012, and now maybe pregnant. No adverse effects were reported. Other suspect therapies included Hepatitis B vaccine (manufacture unknown). No concomitant medications were reported. The patient was awaiting results of pregnancy test. The outcome was unknown. Additional information is not expected.
Staff member had hot flash and vertigo upon standing. BP 138/101, P 76, O2 SAT 98%.  5 Minutes later BP 132/87, P 77, O2 SAT 99% Symptoms lasted about 5 minutes and he was able to get up and leave without any further symptoms post 15 minutes after injection per staff member's verbal statement. He was leaving his shift to go home.
26 patients received Fluzone Quadrivalent vaccines of 1ml during a flu shot clinic with no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a Consumer (Office Staff).  This case involves 26 patients with unknown demographics, who were vaccinated with a 1 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (Batch number: UJ255AA, expiration date: 30-Jun-2020, dose, route and site of administration was not reported) on 11-Oct-2019.   Medical history and concomitant medications were not reported.  It was a case of overdose.  At the time of reporting, no adverse event reported.  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.
Extremely severe headaches and migraines Fatigue and depression Extreme Mood swings (nothing similar prior to the vaccine) Loss of menstrual period for several cycles Lethargy, loss of appetite
Labored, rapid shallow breathing. Lungs wheezing, skin warm, difficulty breathing and difficulty swallowing. 1 dose of Benadryl and 2 doses of epinephrine.
hx RA on Humira, HTN, IDDM, obesity, OSA untreated, essential tremor, TIA's, recent J&J covid vaccine on 4/8. He began developing symptoms of covid on about 4/14, testing positive on 4/16. Presented due to COVID 19 symptoms including dyspnea.
Patient developed anxiety after first shot (3/7/2021) and then had worsening of anxiety to point of possible manic episode/psychotic break after second dose (3/28/2021). Patient had to be hospitalized due to bizarre behavior and concern of threat of harm to self or others. No history of manic episodes before this event, though patient has a reported history of depression.
0.2ml leaked out; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (0.2ml leaked out) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (0.2ml leaked out). On 29-Mar-2021, INCORRECT DOSE ADMINISTERED (0.2ml leaked out) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.
Itchy, bumpy, red rash on my legs, 10 days after vaccinated; Itchy, bumpy, red rash on my legs, 10 days after vaccinated; This is a spontaneous report from a contactable consumer. A 61-years-old non pregnant female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number EW0167), via an unspecified route of administration on 25May2021 at 16:30 (at the age of 61-years-old) into left arm as single dose for COVID-19 immunization. Medical history included high cholesterol, allergies to penicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. The patient did not receive any other vaccines within 2 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Jun2021 at 07:00 AM, the patient experienced itchy, bumpy, red rash on my legs, 10 days after vaccinated. The patient did not receive any treatment for the events. The outcome of the events was not recovered.
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient just got the shot and he/she was a little sick but now better hope it's all worth it. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Titers test showed the patient required a booster dose of MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.      Pertinent medical history, drug reactions/allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot #, dose and route not reported) as booster for measles, mumps and rubella.     Subsequently, on an unspecified date, the patient had their titers tested during a pre-employment screening, which showed the patient required a "booster dose" of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  At the time of reporting the patient's outcome was unknown.  The relatedness between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the aforementioned event was not reported.
Patient developed injection site reaction, left arm was red and swollen following injection. Upon review, patient was referred to Dr where she received Clindamycin for possible infection.
This case was reported by a nurse and described the occurrence of influenza-like symptoms in a 16-year-old female patient who received BEXSERO (batch number 156801A, expiry date August 2017). In October 2016, the patient received the 1st dose of BEXSERO (intramuscular) 0.5 ml. In October 2016, less than a month after receiving BEXSERO, the patient experienced influenza-like symptoms and unwell. On an unknown date, the outcome of the influenza-like symptoms and unwell were unknown. It was unknown if the reporter considered the influenza-like symptoms and unwell to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient reported felling ill such as experiencing flu like symptoms. The reporter was unable to get more information. This case was linked with cases US2016161492 and US2016GSK196395, reported by the same reporter.
Fever/chills, body aches, headache, sore throat - 24 hrs.
RXN of erythema/ induction on both right and left thigh. Varicella and MMR inj. site.
As soon as patient exited the vaccination room and sat in the waiting room chair she started to feel lightheaded and slumped over and fainted.  She lost consciousness for less than a minute.  She lost color in her skin and was confused when she woke up.  Her mother and brother were with her and called for help.  The pharmacist and a technician also went out to assist.  Patient was seated in the chair and assisted the whole time not to fall out or get up and walk after waking back up.  She was given a cold compress and water.  Her blood pressure was taken and was WNL. We asked them to stay in the pharmacy an additional 15-30 minutes after to watch over her.  Her mother and brother were able to stay with her in the waiting room.  After resting for an additional 20 minutes patient was able to walk out on her own and color returned to her body.  Her mother felt comfortable taking her home at this point.  Patient is very nervous about shots and had little to eat today.
Physical exam and immunizations (MMR and DTaP) yesterday. Child woke up today and mom noticed swollen lateral part of left thigh at immunization sites and swollen to knee. Cool touch. No redness, minimal pain.
Patient given bivalent vaccine and is outside the approved age range by 2 weeks.  No adverse reactions reported by parent outside typical side effects seen with routine vaccination. Parent has been informed by our physician on 9/27/22 and told to contact us with any questions or concerns. No further follow-up needed.
The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a "severe reaction" to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours, the symptoms were the most severe and he was going to seek medical attention, but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21, when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER.
Patient developed a very light scab on the injection site area about one week after receiving the vaccine. No further adverse events associated. The scab began to go away after a couple weeks.
All of the s/s of the regular flu. I have not seeked help from my doctor yet. At this present time it is close to 48 hours post onset. I will give it one more day to see if things improve. On 11/16/2009 the fever got worse in the evening hours.
The nurse administered my flu shot incorrectly. She gave it too high. I have had shoulder pain ever since. My PCP and chiropractor confirmed that the shot was the cause of the pain and that the injection went into a tendon, cartilage, or bursa instead of my muscle. I had limited mobility and couldn't lift my arm all the way. Through chiropractic care, muscle relaxers, and physical therapy exercises, I have regained use of my arm, but I still have a deep aching pain. My PCP told me the pain may take around 6 months to resolve.
Abdominal pain/cramping, diarrhea, fatigue, dizziness, chills, fever, feeling faint, brain fog/difficulty concentrating, facial pressure/numbness
Face is red and burning every few days - for days at a time.   Feels and looks scalded.
Patient reported upon awakening Saturday morning (day after vaccines were received 9/9/23) she was very dizzy and nausea. These symptoms went on into the next day, Sunday at which the patient had a fall that resulted in the ER. When she came to the pharmacy today she had black eyes and bruises on her face from the fall. Said she was still having symptoms and had just seen her PCP for the symptoms. Was given zofran and scopolamine patches to help with signs and symptoms.
Ever since I received the vaccine, my arm has been extremely sore. Over the next few days, I became incredibly itchy and developed a rash on both of my arms. I now have what I think is considered, "COVID Arm". There is a red circle around the injection site that is swollen, red, and tender. I then noticed the inside of my mouth was sore and I had blisters developing on the roof of my mouth near my gums. My throat is super sore and swollen and has a yellow pocket on the back of my throat. I am also having body aches under my arms near my ribs and back.
Body aches and chills started at 2:00 am and ended later that night. I used tylenol for the aches.  After the chilling stopped, I started feeling really hot.  When I slept, I would sweat a lot.
Breast cancer with metastatic disease to brain, complaints of headaches, received vaccine and admitted for brain lesions, radiation, currently admitted
The nurse injected my left shoulder just below the subacromial space. (I am a Physical Therapist) I had undergone shoulder surgery about 4 years ago and I emphatically told the nurse to stay away from the joint. She insisted that she was trained to inject the vaccine up high and before I could object she pushed the needle in. She told me that she was getting a lot of push back and the injection leaked out.  I told her she was too high up on my shoulder. I also got a tetanus in my right shoulder and before she gave me that shot I told her once again to inject it into the deltoid NOT my joint. She did inject slightly lower but still too high on that side too. I am now having constant pain in my left shoulder to the extent of not being able to lay on that side when sleeping. I was able to sleep on my left side before the injection. (My right side is doing ok). I am taking Ibuprofen 2 to 3 times a day and my symptoms feel like my shoulder felt after the shoulder surgery. I did report the incident to the Hospitals nursing staff director.
Received dose 1 of Pfizer Covid vaccine on 12/22/20, reported she noticed small bump on the side of her neck the next day or so. No systemic symptoms. Did not seek treatment/evaluation. Received second dose (lot EK9231) on 1/13/21 and reports that the bump is tender and has gotten bigger.
#1 GARDASIL administered on 8-17-12, no reaction local or systemic - broke out in hives 9-8-12. ER visit - record sent.
The patient was anxious for a week before her second vaccine. After vaccination she again was anxious but did not want to be transported. Her daughter who drove her said she was able to take her to her Dr. if the problem persisted. We ran an AMA and released her to her daughter. Pfizer Covid 19 EUA
The worst headache I've ever had in my entire life; it was like someone was driving nails thru the backs of my eyeballs.  It started on the day after the second shot and progressively got worse throughout the day.  It forced me to lie down in a dark room and go to sleep.
Pt called  call center on 4/23/21. Pt got second dose Pfizer vaccine on 4/22/21 and first on 3/30/21. Pt complains of fever 99.5 F and states when he went for a walk outside 4 hours ago and as he was talking to his neighbor he felt dizzy, blacked out for a few seconds, had weakness in his legs and fell and bruised his knees. Advised pt this is an emergency symptom and need to go to emergency room immediately. Pt states he will think about it but verbalized understanding that this an emergency symptom and need immediate attention.
After getting the vaccine I got sick with something they call Vasculitis is process caused by inflammation of the blood vessel walls, which affected my lungs and caused me to have problems breathing to the point where now I?m on oxygen   I?ve been in the hospital twice and they did a biopsy and a bronchoscope . I never ever had these problems before but once I took this vaccine it affected my body and changed my life .  I haven?t worked since May 20,2021 I?ve been out on medical leave and right now I?m not able to go back because of being on oxygen
crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.
Fever 103.0 (F)X4 days with onset <24 hours from immunization. Diarrhea, fatigue, chills. Swelling from left deltoid to elbow with redness and tenderness to site. Patient remains symptomatic 4 days post immunization.