chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt very lethargic; barely unable to get out bed; no energy/extreme weakness; no appetite; low grade fever; extreme fatigue; throbbing pain in her arm which increased in intensity; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing pain in her arm which increased in intensity), LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness) and DECREASED APPETITE (no appetite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (throbbing pain in her arm which increased in intensity) and HEADACHE (very bad headache). On 12-Mar-2021, the patient experienced LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness), DECREASED APPETITE (no appetite), PYREXIA (low grade fever) and FATIGUE (extreme fatigue). At the time of the report, PAIN (throbbing pain in her arm which increased in intensity), LETHARGY (felt very lethargic), BEDRIDDEN (barely unable to get out bed), ASTHENIA (no energy/extreme weakness), DECREASED APPETITE (no appetite), PYREXIA (low grade fever), HEADACHE (very bad headache) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On her second dose, patient felt less tired right after the vaccination. It was noon when it happened and she only felt slight headache. The next day she felt tired but went to the salon for her hair appointment. Said she still felt tired and drove slowly back home. When she got out from her car in their garage, she felt freezing cold and her teeth were chattering hard. Said she rushed upstairs, turned on the heater and used the electric blanket. Said her temperature was 101 degrees Fahrenheit and she had  very bad headache. She rechecked her temperature and it became 102, lymph nodes were tender and painful to touch, ears were throbbing and there was shooting arthritic pain everywhere; like a Ping-Pong ball response. Her thighs and legs felt they were on fire, air felt like hurting her skin and felt head was exploding. Patient she only took the migraine pill again for the symptoms and it subsided but fatigue went on for 7 days.  no concomitant medications and treatment details reported.   This case was linked to MOD-2021-163478 (Patient Link).
Within 1hr of vaccination patient vomited, and started showing signs of pain and disorientation. For a week after symptoms began he was unable to crawl correctly when he was previously close to walking, he cried out continually as if he was in physical pain.
TINGLING AND MUSCLE ACHING IN HANDS , WRIST, AND FOREARMS. DID HAVE 2 EPISODES OF VERY BAD HEADACHES. NIGHT OF SHOT , AND 2 WEEKS LATER.
Pt was exposed to chicken Pox and had a mild, papular, pruritic rash.
increased heart rate after 2 or 3 days after getting 2nd dose normal?; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate after 2 or 3 days after getting 2nd dose normal?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (increased heart rate after 2 or 3 days after getting 2nd dose normal?). At the time of the report, HEART RATE INCREASED (increased heart rate after 2 or 3 days after getting 2nd dose normal?) outcome was unknown.            Concomitant medicine and Medical history were not provided. Treatment medicine were not reported.
Surrounding erythema (about 5 cm in diameter) appreared very shortly after administration of either HiB or IPV in right thight.  Knot develop at site.  Pt had fever to 101 for 2 days.  Antibiotics were prescribed (Bactrim, then Clindamycin), but pt did not tolerate any doses of either.  The erythema resolved in 3 days, but the small knot, and tenderness at the site, remain.
Product Complaint; administered under the recommended volume; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number M2735, expiry date 21-MAR-2024) for prophylaxis. This case was associated with a product complaint.   On 19-OCT-2023, the patient received the 1st dose of Arexvy. On 19-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: administered under the recommended volume). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 19-Oct-2023 A pharmacy intern called in to request information about the validity of a vaccine dose that had been administered being under the recommended volume.  They provided partial information about the event, patient and vaccine. A product quality complaint was filed. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received less than recommended volume of Arexvy vaccine, which led to incomplete dose administered.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. During the timeframe from 09-JUN-2015 to 07-JUL-2015, the patients received ROTATEQ (lot # K023532 and expiry date of 21-JUN-2016) (oral, unknown strength and dose), which was improperly exposed to 10.9 degree centigrade for 494 hours. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports received from the same reporter. Additional information has been requested.
Pt vaccinated with MMr 1/2 hr after vaccine c/o shortness of breath & lightheadness. No unusal breath sounds heard but Benadryl & Epinepherine given as a precaution w/ child's hx of allergies.
Shot hurt more than it should when given. After 15-20 minutes arm felt tingling and cold. Patient panicked and became dizzy.
I contracted COVID-19 on 03/24/2022 with symptoms of fever, coughing, runny nose, congestion, fatigue, and chest tightness. On 03/25/2022 I went to the Hospital where I was tested, X-ray diagnosed COVID-19 Pneumonia, and I was prescribed Azithromycin and Benzonatate. I received the COVID-19 Pfizer Vaccine Dose 4 03/30/2022. I was feeling better by 03/30/2022, but was still felt fatigued for several more days.
Bilateral pulmonary embolism (PE); Shortness of breath (SOB); This spontaneous case  was retrieved on 25-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1857195-1), reported by other healthcare professional and concerned a 61-year-old, female patient.   The patient's concurrent conditions included alcoholism, hypertension, hyperlipidemia, asthma and allergy to ACE inhibitors, causing cough. The patient's concomitant medications included hydrochlorothiazide and citalopram, both used for an unreported indication.   On 20-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, dose, anatomical location and indication: not reported). The batch number reported was 308481.  On the same day, the patient was vaccinated with non-company, co-suspect Boostrix (diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid; route of administration: intramuscular, dose, anatomical location and indication: not reported). The batch number reported was MR5RK.  On 27-Oct-2021, seven days after receiving Flucelvax Quadrivalent and Boostrix, the patient experienced shortness of breath (SOB).   On 28-Oct-2021, the patient was seen in the doctor's office for SOB, had unspecified testing (labs/imaging as reported) and was admitted for bilateral pulmonary embolism (PE). Ultrasound (U/S) and echocardiogram (echo) were planned.   At the time of initial reporting, the patient had not recovered from the events.   The reporter did not provide causality assessment.  Both events were assessed as serious due to seriousness criterion of hospitalization. Additionally, the event of 'pulmonary embolism' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 61-year-old female patient developed dyspnea and bilateral pulmonary embolism 8 days after receiving Flucelvax Quadrivalent and non-company co-suspect Boostrix vaccines. The patient's concurrent conditions included alcoholism, hypertension, hyperlipidemia and asthma. Causality for the reported events is assessed as not related due to biological implausibility.; Sender's Comments: A 61-year-old female patient developed dyspnea and bilateral pulmonary embolism 8 days after receiving Flucelvax Quadrivalent and non-company co-suspect Boostrix vaccines. The patient's concurrent conditions included alcoholism, hypertension, hyperlipidemia and asthma. Causality for the reported events is assessed as not related due to biological implausibility.
Fever greater than 103 Dry heaving Diarrhea Extreme headache Chills Sweats Extreme fatigue Dizziness Blurred vision Lethargic
The pt received Hep B on 4/23/01. Mother states the pt woke the next morning and was having trouble breathing and chest hurt. He  thought he was dreaming. He also complained of chin hurting. He thought he may have asthma like some one else he knows. The pt's face turned pale and then flushed. He also complained of a stomach ache.
The patient was to get a shingrix vaccine. A pfizer covid vaccine was picked up and inserted into the left deltoid. No vaccination from the pfizer syringe was injected, the needle was removed and the patient received the shingrix vaccine in the left deltoid. The pfizer vaccine was wasted, and the patient was asked to wait 15 minutes. The patient received both covid vaccinations at another facility early in 2021.
Clients wife called to report adverse event. Wife reported client having episodes of lungs feeling like they are burning, experiencing shortness of air when walking thirty to forty feet, and elevated blood pressure at times of episode. Wife reported she has called primary care provider to let doctor know. Doctor referred client to see his lung doctor as soon as possible. Wife reports they are in another state working on their farm and is having trouble getting client to cooperate to go to doctor. Clients wife reported primary care provider recommended going to ER as soon as client experiences any of those symptoms  again.  Educated wife the importance of listening to providers recommendations. Clients wife reported client using his own CPAP machine when episode occurs and it does  bring some relief to symptoms.
This spontaneous report as received from a medical assistant refers to unspecified number of unknown patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M020103, expiry date 15-FEB-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced temperature excursion ranged from 1.8 to -1.5 degrees Celsius for cumulative time of 11 hours and 30 minutes. Data logger was involved. There was no previous excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Last night I had the severe chills and fever that went up to 100.1; Last night I had the severe chills and fever that went up to 100.1; This is a spontaneous report from a contactable consumer (patient herself).  This 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 28Dec2020 on the evening at single dose for COVID-19 immunisation. The patient did not have a relevant medical history and relevant concomitant medications. The patient was vaccinated at hospital, age at vaccination was 72-year-old. On unknown date in 2021 (last night, as reported), the patient had the severe chills and fever that went up to 100.1 (units unknown). Blood work was done about week and half ago and results were not provided. The patient took two paracetamol (TYLENOL) about 11:00 pm last night for the events. The patient verbally stated ''I don't know if I am having a delayed reaction to the vaccine or if I am having some kind of viral infection, something else but I want to report this possible reaction''. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Ongoing shortness of breath, cough, left-sided chest pain eventually diagnosed as Pericarditis by cardiologist.
mom called 1400 to report pt had had 2-3 about of vomiting/diarrhea since DTP/HIB/OPV this AM; also reports listless pt not making good eye contact & febrile;
After receiving my second Covid 19 vaccine, within a day or two my ear felt stopped up. I thought I was going to get a cold or something. It continued to feel stopped up. Tinnitus started. I thought perhaps I had built up wax in my ear. I used ear drops to try to clear it out. Finally went to my family physician. She said everything looked fine. Referred me to an ENT. First thing he did was a hearing test. I had lost over 80% of my hearing. Tried treating it with steroids but, it was too late. The loss is permanent. If I had known this was a possible side effect, I could have reacted quicker to be treated. At least I would have had a CHANCE to save my hearing.
Based upon follow-up information received 29 August 2008, this case was upgraded to serious.  Initial report received on 21 April 2008 from a health care professional.  A 23 year old female patient received on 11 April 2008 an intramuscular left deltoid 0.5 ml injection of ADACEL (lot# C2889AA), and intradermal left forearm 0.1 ml injection of TUBERSOL (lot# C2805AA), a subcutaneous right arm 0.5 ml injection of MMR (Merck, lot# 08656), and an intramuscular right deltoid 0.5 ml injection of ENGERIX (GSK, lot # AHBVB438AA).  It was determined that the patient was pregnant at the time of vaccination.  Her last menstrual period was 04 March 2008 and her expected date of confinement was 09 December 2008.  No prenatal testing was reported.  The patient's past obstetric history included one live full-term birth with no congenital anomalies.  No medical history or current medications were reported.  No adverse event was reported.  Follow-up information was received on 29 August 2008 from a health care professional.  The patient's obstetric history included four prior pregnancies, of which one had been a full term live birth with no congenital anomalies.  It was unknown if the patient had any elective or spontaneous abortions, prior to, or greater than 20 weeks gestation, other than the pregnancy pertaining to the reported event which occurred on 20 April 2008.  The patient had a positive urine pregnancy test on 18 April 2008.  She presented to the emergency room on 20 April 2008 at which time an ultrasound showed an empty uterus - spontaneous miscarriage.  At that time, her HCG was 2857; and had previously been 3071 on 18 April 2008.  According to medical records received, her ultrasound showed no embryonic pole, but there was a positive yolk sac, and the patient was sent home with precautions.  She had significant bleeding when she passed "a lot of stuff" that looked like it may have been tissue.  She had a follow-up evaluation on 08 May 2008 at which time she discussed an interest in birth control.  Her quantitative HCG had been less than 2 at that visit.  Additional test results had been negative for Chlamydia and gonorrhea.  The patient was scheduled to follow-up in two weeks to have an IUD placed.  The patient's recovery status was not reported.  On 09 May 2008, the patient received a second dose subcutaneous injection of MMR, lot number 0040X which was received after the reported event.  The patient has since become pregnant again, and her last menstrual period had been 21 June 2008.  No further information was provided.
SWELLING ABOUT 2 INCHES REDNESS AND HOT AROUND THE SWOLLEN AREA.
experience appendicitis like pain in abdomen/diagnosed with a perforated appendicitis; This is a spontaneous report from a contactable consumer (who is also the patient). A 61-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm, on 31Mar2021 12:30, as single dose, for covid-19 immunisation. Medical history included known allergy to sulfa drugs. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). On 01Apr2021 at 13:30 (reported as "24 hours after the first Pfizer jab on 31Mar2021"), the patient experienced appendicitis like pain in abdomen. She was diagnosed on 04Apr2021 at the emergency room (ER) with a perforated appendicitis. This resulted to hospitalization for 3 days in Apr2021. Treatment for the events included "CT scans and IV antibiotics". The patient underwent lab tests and procedures which included computerised tomogram (CT scans): perforated appendicitis; and COVID nasal swab: negative, both on 04Apr2021. The patient was recovering from the event.  Information on the lot/ batch number has been requested.
Patient says on November 8th he developed an ulcer in his mouth. Then went to his lips. He had visited his pcp twice. When his tongue got white and bleeding he went to emergency room. Then he went to an ENT.  He had areas on his body and then went to a dermatologist who perfomed a biopsy.  She diagnosed pemphigus vulgris.
Rash on bilateral lower extremities for 2-3 weeks.  Now has diffuse rash sparing soles, palms, and face x3 days.
This case was reported by a consumer via Regulatory Authority and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles, and pain to be related to Shingles vaccine. Additional details were provided as follows: This case was reported for patient's husband. The age at vaccination was not reported. The reporter stated the patient got the Shingles shot and had shingles, his in lower right back area.  The reporter stated had been broke out about a month and at the time of reporting complaining of some pain. The reporter stated the patient got the Shingles shot that's why was not as bad as some. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Information has been received from a registered nurse concerning a 54 year old female with unspecified medical history who on 11/7/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine 0.5 ml (lot 650329/0747P) Concomitant therapy included unspecified medication. Subsequently, the patient developed a swollen, red arm. The patient was seen in the doctors office. The patient was diagnosed with cellulitis and was treated with oral antibiotics. The patient was reportedly doing well. The reporting nurse considered cellulitis to be disabling. It was also reported that two other patients experienced cellulitis after being vaccinated with Pneumococcal 23v polysaccharide vaccine WAES0511USA01525 and WAES0511USA02280. the reporting nurse requested a lot check. Additional information has been requested.
patient stated was sitting in the chair after receiving the vaccine 10 minutes later he started experiencing dizziness and light headiness then he started feeling cold and feverish at one time like he was about to pass outpatient was evaluated and assessed the vitals are as followed 2:44p b/p 112/65 p 98 r 18 sat 98% 3:00p b/p 117/73 p 93 r 18 sat 93% 3:10p b/p 120/74 p 83 r 18 sat 98% patient stated he was feeling better patient was wheeled to the front entrance patient was encouraged to go to the nearest ER was to reoccur. Patient was released home.
Signs of neurological and nerve damage such as twitching and first to occur soonest after vaccine was SEVERE leg pain (especially in left) cramping to the point of waking up out of sleep screaming. Later began chest pain and trouble breathing, after 2 ekg's at Hospital came back abnormal (showing 'old heart attack') I visited my Doctor next day and again showed an abnormal ekg, breathing test showed extremely low lung functioning, they are expediting me to see a specialist for both (appointment is still in future). Also, since the vaccine, SEVERE back pain in spine, get stuck in certain positions in pain so badly causes outburst moans of pain, got xray waiting for results, Dr also put in referral for physical therapy. Did labs with included fasting which show my cholesterol is now high, I am thin, healthy, and work out when my body can handle it, this is bizarre. Had none of these issues (labs were all fine as well) before vaccine. My body is completely different and unpredictable now, my legs are unable to handle much of anything, along with my back, I have been prescribed inhalers for breathing now as well. I do not smoke, drink, nor use any drugs.
Pt devel redness, soreness & an infect p/T vax; No additional info is available regarding this event;
Patient tolerated first and second Covid-19 shots well, but after second shot and waiting about 15 minutes, was found to be weak and lightheaded, short of air, had difficulty walking and complained of a headache.  She stated she had returned from seeing a pulmonologist for the SOA, and was told to go home, and that appointment to see a cardiologist would be made within 2 weeks.  Pharmacist was NOT comfortable sending patient home (she was with her husband), and both agreed that 911 should be called to take her to Hospital.  EMS personel evaluated her onsite and transported her at about 12:15 PM, 4/23/21.
Patient developed lethargy and severe headache about 24 hours after vaccine administration... he has no history of significant headache/migraine in the past.  The pain was so severe he could hardly walk and was taken to the ER for evaluation including CT scan (normal) The pain slowly subsided in the ER to the point where he was discharged home but still persists to a mild extent today.  He has an otherwise normal physical/neurological exam.
Received vaccine on 11/13/08 and developed itchy rash that spread on arms, legs, face. Evaluated on 11/17/08 and dx with chicken pox.