chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About six hours after the injection I experienced discomfort in my throat, mild swelling in both hands and face, some tingling in face,  and head ache.I  took Zyrtec 10 mg, Pepcid AC 20mg.  Then I started to have tightness in my chest and used my albuterol inhaler.   I was still having symptoms an hour later so took Benadryl 25 mg.  During the night I woke up with mild wheezing and used my inhaler again.  Throughout the next 2 days, I continued to have these symptoms (except for wheezing) off and on.  Today, I still have some symptoms but not as often or severe.
Covid arm red spots; Onset of fever 101.7; Chills; extreme headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP). The patient was allergic to penicillin, sulfa and nickel. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and amlodipine besylate (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 08Mar2021 at 15:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021 at 17:30, the patient experienced chills, extreme headache and fatigue. On 29Mar2021 at 18:00, 5 hours after the vaccination, the patient had onset of fever 101.7 lasting 37 hours even with paracetamol (TYLENOL). On 01Apr2021 (reported as day 4), the patient had covid arm red spots. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure taken as a result of the event onset of fever 101.7 included treatment with paracetamol (TYLENOL). The patient did not receive any treatment for the events chills, extreme headache, fatigue and covid arm red spots. The clinical outcomes of the events onset of fever 101.7, chills, extreme headache, fatigue and covid arm red spots were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Narrative: COVID infection following COVID vaccine series 08/19 Janssen, dose #1 09/07 COVID swab, result: detected 09/07 pt cc: exposure: unknown 10/07 CXR impression: No active disease.
Pt had covid RNA gene therapy in April 2021 and 12/21; first J&J then Moderna.. After first vaccine had a colitis flare treated with steroids and mesalamine.
This spontaneous report as received from a Registered nurse and refers to a currently 19 year old male patient. On 01-AUG-2013, the patient was vaccinated with the first dose of pediatric VAQTA (dose, route, lot and batch number, expiration date not reported). On 13-AUG-2014, the patient was routinely vaccinated with the second dose of pediatric VAQTA (dose, route, lot and batch number, expiration date not reported). No adverse effects were reported. The patient's outcome was unkonwn. Additional information has been requested.
Fever, chills, inflamed lymph node under left armpit, pain in left arm and under left arm.
His leg has been red, swollen, hot, and itchy - he scratched it all weekend. Attached is a photo from sunday afternoon (45 hrs after the shot). It is less red, swollen, and not as hot to the touch this morning.
Moderna Arm.     Big red circle with lumps under the skin,  bumps and itching.  Did nothing after looking it up.  Gone in 5 days.
Information has been received from a certified medical assistant (C.M.A.) concerning a female patient between the ages of 11 to 15 years old who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil, (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. This is one of several reports from the same source. Additional information has been requested.
After the 36 hours of expected chills, dizziness (no fever), and fatigue resolved,  4 days after vaccine, developed chest pain, burning down right leg, tingling and feeling of rapid heart beat.  Being a nurse practitioner myself, and knowing the symptoms of serious things, I did not want to "overreact".   I waited a few days for symptoms to resolve, which they didn't .     I then was advised by my primary doctor to go to ER for evaluation.
Child presented to clinic on 7/28/2023, with facial swelling, parent stated this occurred on 7/21/2023. Child denies and shortness of breathe, difficulty breathing or itching. Parent advice to take child to PCP.
tightness of the throat; dermatographia hives; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (tightness of the throat) and MECHANICAL URTICARIA (dermatographia hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21A, 022C21A and 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MECHANICAL URTICARIA (dermatographia hives). On an unknown date, the patient experienced THROAT TIGHTNESS (tightness of the throat). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (tightness of the throat) and MECHANICAL URTICARIA (dermatographia hives) outcome was unknown.            No concomitant medications reported.  Consumer reports that she has been having dermatographia hives since 16Dec2021, 11 days after she got the booster dose of the Moderna Covid-19 vaccine. She states that she has itching hives anywhere her skin is touched. She also experienced tightness of the throat. She consulted with her primary doctor which did not make any connection to the vaccine but when she consulted her allergist - she  said that this may be vaccine related as she has seen a lot of patients with hives after having the booster or the 2nd round of the Moderna Covid-19 vaccine. She mentioned that she is a member of a support group which has 1200 members who had chronic spontaneous urticaria as side effect of the vaccine.   This case was linked to MOD-2022-437628, MOD-2022-437391 (Patient Link).
Full body hives and rash, extreme and severe allergies for the past month and won?t go away!!
Reaction to varicella shot #2. Vaccine site is red and swollen, no medication or fever. No other vaccines were given on this date 02/28/2012.
Information has been received from a nurse referring to an 11 year old female patient. There was no medical history or concurrent condition reported. On an unknown date, when the patient was a child, she was vaccinated with the first dose of M-M-R II (dosage, strength, route and indication were not reported). The patient had not been revaccinated prior to elementary school entry. On 06-AUG-2015 the patient went to office to vaccinated with M-M-R II dose 2 (dosage, strength, route and indication were not reported)(Inappropriate schedule of drug administration). At the time of the report, no adverse effect was reported. The outcome of the event was unknown. Additional information is not expected because the reporter was not consented to be contacted.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a male 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: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 09-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported.  On 09-NOV-2022, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20221141786 and 20221141814.
Systemic: Hypertension-Mild, Additional Details: patient had acute hypertension 90 minutes after vaccine. not sure if related but wanted to report. went to er and they gave her meds to calm and bring down bp. only lasted a few hours
She was feeling like she was going to faint/ very shaky on 2/8/19. Right thigh pain and sore arm. She had to come home from school that day and it lasted about 1.5 days. She currently has had headaches for the past few days as well as exhaustion and a general feeling of malaise.
Inflammation at the injection site with induration, erythema, and tenderness. Throbbing pain at the injection site. Lightheadedness intermittently. Increased temp with highest being 99.9 with Tylenol onboard.  Pt also had the pneumococcal vaccine administered in the right shoulder but has no localized reactions at that site.
The vaccine that was provided was given at day 33 from fridge storage, rather than within the 30 days after thawing.
Pt was given expired Moderna Booster 0.25 in right deltoid on 10/26/2021, this lot number expired on 10/8/2021. Patient was contacted by Health Pharmacist , no adverse effects of medication for noted by patient.
Initial unsolicited report received from consumer via social media in on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131486, 2016SA131491 (same vaccine, same reporter). This case involves a patient (age and gender: not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after getting the vaccination the patient died. It was unknown whether autopsy was performed and cause of death was unknown. Documents held by sender: none. Sender's Comments: This case corresponds to a poorly documented and non-medically confirmed social media report. Patient presumably received meningococcal vaccine for which the manufacturer was unknown. Clinical details- such as patient's age, medical history, vaccination details, the name of the specific vaccine administered, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: death.
rush in the brain after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (rush in the brain after the first dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (rush in the brain after the first dose). At the time of the report, HEAD DISCOMFORT (rush in the brain after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported  Symptoms: It was reported that the patient was not immunocompromised.   This case was linked to MOD-2021-402795 (Patient Link).
A non-serious spontaneous report of allergic reaction with symptoms of swelling and pain of lips has been received from a physician concerning an adult female subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 03-Nov-2010. On 08-Nov-2010, the patient developed swelling and pain of her lips. The reporter was doubtful that an allergic reaction could develop five days later. The outcome of the event was unknown.
Patient called 8/1/14 reported got sweat that evening and little bit of headache -> had raised red area around injection site was itchy at injection site with a small rash around it -> Instructed patient to use ice and apply BENADRYL cream and report if worsens.
Flare up of tinea pedis.  c/o rash all over body.  Started on her right foot, then migrated up the body.   Patient prescibed Benadryl, and Sporanox.  Referral to Dermatologist
Was admitted and tested positive and put on ventilator; She felt slightly ill the day of vaccine; 2 days later patient become ill; tested negative 2 times over the following 10 day while deteriorating; Patient died 10 days later; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This consumer (daughter) was reported for a female patient (mother). A 76-year-old female patient received first dose of bnt162b2 (Pfizer), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included lupus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient with lupus received 1st dose of vaccine. She felt slightly ill the day of vaccine. 2 days later patient become ill, tested negative 2 times over the following 10 day while deteriorating. Was admitted and tested positive and put on ventilator. Patient died 10 days later. Daughter thought she had COVID before vaccination. Event took place after use of product. The patient underwent lab tests and procedures which included COVID-19: negative (tested negative 2 times over the following 10 day while deteriorating), COVID-19: positive (Was admitted and tested positive and put on ventilator) all on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Patient died 10 days later
Information regarding PREVNAR was received from a pediatrician regarding a 16-month-old female patient who experienced Invasive Pneumococcal Disease - drug ineffective, pneumococcal bacteremia and sepsis. The patient died. The patient received the fourth dose on 16-Apr-2008.  No significant medical history. Concomitant medications were not reported. The patient was seen at the doctor's office on 17-Aug-2008. She was fussy and clingy and had a temperature. The child returned to the office on 19-Aug-2008, at which time, she was afebrile and tachypnic. The physician sent her to the ER for diagnostic tests (see test results) and treatment. The child died in the ER. It was determined that the patient experienced Invasive Pneumococcal Disease - drug ineffective on 17-Aug-2008, pneumococcal bacteremia, and sepsis on 19-Aug-2008. The physician stated that IPD was due to serotype 33F, which was not covered by PREVNAR. An autopsy was performed, however results were not available. No additional information was available at the time of this report. The cause of death was reported as sepsis and pneumococcal infection and the autopsy cause of death was not reported. Body temperature (results: fever) was done on 17-Aug-2008. On 19-Aug-2008 test results were: body temperature (results: afebrile); chest x-ray (results: revealed pneumonia); and blood culture (results: revealed S. pneumoniae; Serotype 33F).  10/17/08 Autopsy report states COD as acute lobar pneumonia complicating CHF following viral myocarditis.  10/17/08 Reviewed autopsy report, death certificate & extensive hospital & PCP medical records received for coroner.  Records reveal patient experienced fever & difficulty breathing x 2 days.  Seen by PCP & sent for admission.  Tx w/IV antibiotics.  Became tachypneic, tachycardic & intubated for impending respiratory failure.  Developed bradycardia.  CPR & transcutaneous pacing initiated.  Transported to higher level of care for PICU.  Upon arrival, had blood in ETT & was acidotic & despite continued resuscitative efforts expired. FINDINGS at Autopsy: severe viral myocarditis w/marked patchy myofibrillar nectosis; chronic lymphocytic bronchitis; acute bilateral pan-lobar pneumonia; acute passive visceral congestion; pleural & pericardial effusions; ascites; mild focal lymphocytic meningeal infiltrates; early neuronal anoxic changes; acute splenitis.
This patient was pale weak and sweating. According to Dr's note dated 11/08/00. This student felt weak and shaky 5 minutes after receiving Hepatitis B vaccine. Orange juiced was offered, and Epi pen 0.15 mg given.
Heart Palpitations, PVC, Rapid Heart Beat Swollen lymph nodes around left clavicle and lower neck. Fatigue Pain in upper back
After the second shot administered on 04/18/21 I developed pain at the injection shot left arm, massive swelling in armpit, swollen glands in neck and chest pain. About 2 weeks later the injection shot pain, armpit swelling and chest pain subsided. The swollen glands in the neck however were coming and going. In mid-June I was bedridden for several days with swollen neck glands and extreme fatigue.  I went to an urgent care where blood was drawn an anti-inflammatory and antibiotic injection was given along with a course of oral antibiotics. After a nights rest I felt much better.  It has been 4 months since my 2nd dose and the glands in my neck are still swollen. I have been given a CT with/without contrast to determine the origin of swollen lymph nodes in neck. Additional blood work. An ultrasound of soft tissue in neck.
Diluent without lyophilized component; Patient received the diluent portion of Shingrix without the lyophilized component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number AT772, expiry date 05-OCT-2023) for prophylaxis.  On 08-FEB-2023, the patient received the 1st dose of Shingrix. On 08-FEB-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Diluent without lyophilized component) and inappropriate dose of vaccine administered (Verbatim: Patient received the diluent portion of Shingrix without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 10-APR-2023 A pharmacist called in to report that a patient had received the diluent portion of Shingrix without the lyophilized component. They wished to know what information was available and gave information about adverse event. The vaccine administration facility was the same as primary reporter.  The reporter had consented to follow-up. At the time of reporting, the patient only had received patient had received the diluent portion of Shingrix without the lyophilized component, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: patient complainted of rash, swelling, no pain, lack of energy and loss of appetide-Medium
Patient recently diagnosed (Feb/March 2022) with spine disease, i.e. bulging/slipped discs, E. Coli infection, kidney injury, kidney stones, cystitis. No COVID/respiratory illness disease, had what she thought was a sinus infection in Feb 2022, covid not diagnosed. Denies recent cold/flu/covid symptoms. Otherwise, 4/15/2022 Real-Time Reverse Transcriptase PCR, positive, asymptomatic, testing due to other illnesses requiring hospital admission.
Provider ordered Pentacel, only the liquid was given.  Patient family is aware to return to the office for ActHIB.  Reeducation was given to staff members
Tingling/crawling sensation in left shoulder/neck/cheek. Sensation only felt when holding still. As time went on, the tingling left the face/neck area but is still in shoulder area..many times daily.
no medical records received; pt died at home; pt had a positive COVID test on 8/27/21; per death certificate pt died at home with causes of death being  COVID 19 and Acute Atherosclerotic Coronary Vascular Event
It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess the viability of vaccine.
Pt RTC 7/18/12, pt states her 1/2 upper (L) arm was red/swollen since 5 pm 7/16/12 after immunization & on exam pt at mid upper arm is red. Deltoid area is clear from redness/swelling. Pt saw a friend MD & rx for KEFLEX. Pt states that inflammation had subsided since spoke with pt 7/19/12 - inflammation subsided even more.
Acute onset of morbilliform rash first on trunk then over 2-3 days extending to arms and legs.  Cough and low-grade fever.
This case was reported by a healthcare professional (nurse) and described the occurrence of hepatitis b positive in a 70-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included diabetes and dialysis. Concurrent medications included Aspirin, PLAVIX, CALCITROL, XANAX, Risperidone, Carvedilol, ALBUTEROL, NOVOLOG, ACETAMINOPHEN, PERCOCET, SENSIPAR, Isosorbide and Calcium acetate. On 6 December 2011 the subject received 1st dose of ENGERIX B (20 mcg, unknown route, right arm). On 8 December 2011, 2 days after vaccination with ENGERIX B, the subject experienced hepatitis b positive. Relevant test results included a blood draw that showed that the subject was hepatitis B positive on 08 December 2011. The healthcare professional noted that the subject had been negative for titers of hepatitis B for "several months" prior to the ENGERIX B vaccination. The healthcare professional considered the event was life threatening. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B.
At first normal/expected fever, exhaustion and body aches, but graduated into severe throbbing in my right arm and swelling of my little finger and ring finger. Started upon waking  Friday am and visited urgent care on Sunday afternoon. An ultrasound was performed on Monday and no evidence of a blood clot was seen, but throbbing has continued, though less severe today, but some weakness still persists in my right (injecton) arm.
NO ADVERSE EFFECTS AS OF 3/20/23; REPORTING VACCINE ADMINISTRATION ERROR ONLY.