chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: er2613), in left arm and on 16Mar2021 as dose 2, single (Lot number: er8737) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 3 (booster), single (Lot number: 069h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sullfa drugs" (unspecified if ongoing); "asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: 01Nov2020, stop date: 12Jun2022; ACETAMINOPHEN, start date: 03Jan2021, stop date: 12Jun2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: Day 1: symptom onset,(runny nose, fever, sore throat) positive antigen test; (04Jun2022) Negative, notes: Day 4,5,6: negative antigen test; (05Jun2022) Negative, notes: Day 4,5,6: negative antigen test; (06Jun2022) Negative, notes: Day 4,5,6: negative antigen test; (12Jun2022) Positive, notes: Day 12: new symptoms (NO fever, very sore throat with swollen, raw uvula, mild cough) positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) 1 total, administered on 06-MAY-2021 on unspecified arm for prophylactic vaccination. No concomitant medications were reported. On 18-JAN-2022, the patient reported testing positive for COVID-19 with an at home rapid test kit (suspected covid-19 infection and suspected vaccination failure). The patient had symptoms of cough and headache which started on 18-JAN-2022 and symptoms were very mild and could still taste food and had sense of smell. The patient had not taken a PCR (Polymerase chain reaction) test and denied getting a booster dose. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000212966.; Sender's Comments: V0: 20220133024 -Covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination  failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
The patient is a 32 year old female with pmhx of HTN, HLD, DM-II who presents to the ED with fever, chills, dry cough, and body aches that started on 12/22/21. She came in today due to pleuritic chest pain, stating she has pain with deep inspiration. Her vitals on arrival are BP 143/90, temp 99.8, HR 96, SpO2 97%. Heart and lung exam is normal. The patient is alert and oriented, not in any acute distress. ECG is NSR. COVID test is positive. Tops neg. coags normal. CBC and CMP stable. Mag slightly low at 1.6. CXR shows NAP. The patient was given Ibuprofen with improvement in symptoms. The patient's well's criteria is 0. The patient was given supportive care instructions and recommend she do a follow up phone call with her PCP. She was given strict return precautions. She was given RX for pulmicort and Vit D. She was given pulse ox at discharge and order for MAB. The patient is stable for discharge home. She understands and agrees to the plan.
Swelling, pain, hives, redness, tender to touch, blisters, weakness, dizziness . I applied hydrocortisone and 1 pill (Aleve) .
Widespread itchy rash resembling measles  All over torso from neck to lower abdomen and back & buttocks & upper arms  Lasted over two weeks , still experiencing recurring rash & itching after prednisone prescription
Client felt dizzy after 1st Moderna Covid vaccine.   Was taken to EMS area for observation.   Hx of Hypertension with BP med change 2 weeks ago by private MD.   Pt did not eat breakfast.   Ice pack placed behind neck for comfort. Wedge support provided for leg support. Water provided. BP ranged from 191-212/91-106.  Glucose was 98.  O2 sat 95-96.   Dizziness waxed and waned but when present was much improved from onset.   called for ambulance transport hospital evaluation of persistently elevated BP. IV hep lock inserted by  prior to transport to hospital. 12:10: Client was transported.
Information has been received from a health professional concerning an approximately 15 year old female who in 2000 was vaccinated with a dose of hep a virus vaccine inactivated. She then experienced a swollen face and redness at the injection site. Subsequently, the pt's condition resolved. Unspecified medical attention was sought. No further info was available. Additional info has been requested.
Started with chills lasted 3 hours Fever lasted 12 hours took aspirin every fours Headache lasted 12 hours took aspirin every 4 hours The worst side effect was muscle aches. Lasted 12 hours. I am currently taking physical therapy ony right shoulder. The paid was very bad in my right shoulder. I used a massager, used ice and took aspirin. Nothing helped. Iy lasted 12 hours. It is as if the vaccine attacked the weakest muscle in my body.
After administering 2nd vaccine, patient immediately started to faint, eyes rolled back and arms stiffened. It appeared pt had a seizure for about 1 second. Afterwards pt was alert but very pale and felt sweaty.
pt devel fever to 105 on 1MAR92 had a simple febrile seizure; was admitted, had a neg work up; was readmitted 26MAR92 w/complex febrile seizures; began on Phenobarbita;
This spontaneous report was received from a physician, via a company representative, referring to a 15 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. Prior vaccination, the patient's blood pressure was 144/96 (units were not provided) and she was very anxious. On 27-JUL-2018 at 10:00, the patient was vaccinated with the second dose of GARDASIL 9 for prevention of human papilloma virus (HPV) (strength, route, dosage schedule, lot number and expiration date were not reported). On the same day, 15 minutes after vaccination the patient experienced ringing in her ears, facial flushing and started to pass out. During the adverse event the patient's blood pressure was 85/56 (blood pressure abnormal) and pulse was 51 (pulse abnormal) (no further details were provided). The patient sought medical attention but it was unknown by the reporter if she received treatment. The outcome of ringing in her ears, facial flushing, syncope, blood pressure abnormal and pulse abnormal was reported as recovered on 27-JUL-2018. Causality assessment was not provided.
Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 24-FEB-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 (strength, dose, frequency, lot# and expiration date were unknown) intramuscularly for prophylaxis (Inappropriate age at vaccine administration). No adverse effect was reported. Additional information is not expected as there is no consent for follow up.
the second injection caused my flare to worsen; fatigue; multiple joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EK9231), via an unspecified route of administration in right arm on 08Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included psoriatic arthritis, sub clinical hyperthyroidism and allergy to bees. She had her first dose of bnt162b2 (lot EK5730) on 18Dec2020 in her right arm. No other vaccine in four weeks and no Covid prior vaccination. Concomitant medications included methimazole, meloxicam (MOBIC), apremilast (OTEZLA), atenolol and melatonin. She previously took Ceclor and Biaxin and had drug hypersensitivity. Her psoriatic arthritis was starting to have a flare prior to her first injection. She believed the second injection caused her flare to worsen to the point she had difficulty working due to fatigue and multiple joint pain on 10Jan2021. Tramadol was given as treatment. The events were reported as serious- disability or permanent damage. The outcome of events was not recovered.
TESTED POSITIVE FOR COVID-19 AFTER VACCINATION BUT ASYMPTOTIC; This spontaneous report received from a consumer concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced tested positive for covid-19 after vaccination but asymptotic. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 after vaccination but asymptotic was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Decreased upper body strength, arm sore, hard time taking deep breath, extreme fatigue, increased myalgia.
Chills low grade temp (had taken Tylenol) stomach cramps diarrhea and headache  6 hours after vaccine. Still with chills low grade and diarrhea 20 hours later.  Getting Covid tested per ehs
Headache, Fever, sore arm, chills, sweating, fatigue, symptoms resolved 1/15/2021 Narrative: felt ill for 3 days, took motril
Felt like he had food poisoning; He experienced nausea; Vomiting; He had soreness in the arm of the injection site,; Low grade fever; Fatigue; Felt achy; felt a lump; the area was swollen; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (Felt like he had food poisoning), PAIN (Felt achy), VACCINATION SITE MASS (felt a lump), VACCINATION SITE SWELLING (the area was swollen) and NAUSEA (He experienced nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21 and 012LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension and High cholesterol.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Felt achy), VACCINATION SITE MASS (felt a lump), VACCINATION SITE SWELLING (the area was swollen), FATIGUE (Fatigue), VACCINATION SITE PAIN ( He had soreness in the arm of the injection site,) and PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced NAUSEA (He experienced nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced FOOD POISONING (Felt like he had food poisoning). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FOOD POISONING (Felt like he had food poisoning) outcome was unknown and PAIN (Felt achy), VACCINATION SITE MASS (felt a lump), VACCINATION SITE SWELLING (the area was swollen), NAUSEA (He experienced nausea), FATIGUE (Fatigue), VOMITING (Vomiting), VACCINATION SITE PAIN ( He had soreness in the arm of the injection site,) and PYREXIA (Low grade fever) had not resolved.            no relevant concomitant medications was reported.  Action taken with mRNA-1273 in responsible to the events were not applicable
These symptoms began 4weeks ago. Other comments include: She began with eye blinking, then moving the nose, and now also moves mouth side to side. There is no specific trigger per mom. She could just be watching tv and it occcurs.
Contraction on left arm/She developed contracture in the left arm; I can't bend my thumb. The first joint is like in a lock position when I try to bend it is vey painful.; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a 66-year-old female patient (reporter's wife) that: A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) via an unspecified route of administration in Arm left on 04Mar2021 single dose for COVID-19 immunization. Medical history included kidney disease.  The patient's concomitant medications includes yes but I don't know/ taking but don't want to disclose it right now. I am not taking anything different what I was taking before I got the injection. Historical vaccine dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Covid-19 vaccine both doses were administered. After the 2nd shot patient experiencing contraction on left arm almost in a day or 2 after the receiving the injection. It was 26Feb2021 when she received the 2nd shot and after 2-3 days she experienced the side effect. Patient can't bend or move thumb but also cannot bend it from the nail to joint area/ first joint is like in lock position. Unable to keep it in an upright position. When tried to bend it, it's painful and if I don't try to bend it then fine. Causality: Patient stated, "I know this is due to covid vaccine because I don't have problem with my hands until I got injection. After that I have come into the conclusion that I will be different. I got the injection in my left arm and my left hand and left thumb my dominating hand is right hand and I never ever got injection in my right hand in the hospital. They put it in left hand, and I am glad I did right because I think I don't have been going through these problems and as I said I am sitting and talking to you when I sit and my thumb straight up. I don't feel pain but I try to bend to all it very painful you know this is very hard time and difficult to bend my thumb. Patient have appointment with doctor located and x-ray something ever they say that I need to do because I rest my hand on chair or put on my lap that doesn't hurt me. Sleeping on my right side at night. Patient assumption was the little pain experiencing it is goanna be better but it's getting worse. Patient can't use thumb to put the things up. Patient didn't received treatment for adverse event. The outcome of the events was unknown.  Follow-up(19May2021): New information in follow up spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a 66-year-old female patient (reporter's wife) that dates of the onset events, medical history and concomitant product.   Follow-up attempts are needed, Additional information has been requested.
Case number PHEH2014US021611, is an initial spontaneous report received from a consumer on 27 OCT 2014. This report refers to a 43 years old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN (batch number: not reported) on unspecified date (reported as 2 years ago) and was well tolerated without any problems. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 15 OCT 2014. Approximately one hour after vaccination he experienced feeling of burning sensation to his arm, legs, stomach and chest. IT was reported that he felt nauseated and has stomach pain; he feels the symptoms like a rash under his skin. He also experienced tingling sensation in the legs like something affected the sheath in the nerves. It was reported that symptoms of feeling like a rash and tingling increases with any physical activity. He visited emergency room. H had urine test and blood test done and stated that everything was normal. On the paper it states paresthesia. He also had extreme anxiety and brain problems. He was treated with Ativan. It was reported that  he was advised to take an appointment with a neurologist. The outcome, seriousness and causality of the events were not reported.  Upon internal date review performed on 12 NOV 2014 of date received on 27 OCT 2014. Burning sensation in stomach, stomach ache and nausea were taken separate events.
Immediately had blurry vision, bright flashes of light, dizziness, lack of balance, difficulty breathing, chills, flushed face.  Vomited a small amount.  After sitting and sipping water, symptoms went away after 10 minutes.
Delayed skin reaction - hives  I woke up the morning of Sunday (May 9 2021 - 14 days after 2nd Moderna shot) with a mostly full body hive reaction, concentrated especially on my thighs, but the hives reached all the way to the back and top of my head. Face was hive free. Hives are itchy but not unbearable if left alone. Treated with 2 benadryl (Diphenhydramine HCI, 25 mg), reaction went down. Later that same evening, hive reaction returned and worsened over the evening, this time the hives were concentrated on my forearms, especially on my right arm (injection site). The actual local injection site on the shoulder remained relatively hive free. Hives grew and joined together into large blotches. Treated with 3 benadryl. The next morning (May 10) I woke up my arms relatively hive free although there are some minor blotches. Now I have minor red blotches on my face and neck, and some on my lower legs. Treating with 1 benadryl. Will likely not seek medical attention unless hives worsen dramatically. No other symptoms - breathing is fine.   Unclear whether this is actually a reaction to the Moderna vaccine, but it is my best guess. There have been no changes to my diet, medications, or behavior. Bed sheets and clothing have been washed and changed without an effect on the reaction. I am not experiencing elevated stress. The concentration of the hives is moving around my body, so it doesn't appear to be the result of skin exposure or contact.
administered the liquid portion of pentacel without reconstituting with the powder portion with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who was administered the liquid portion of pentacel without reconstituting with the powder portion with no reported adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 08-Dec-2022, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE(strength: 0.5 ml) (lot UJ678AAA)(unknown expiry date) via unknown route in right leg for Immunization.  On 08-Dec-2022 the patient had a non-serious event of administered the liquid portion of pentacel without reconstituting with the powder portion with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  Outcome was Unknown for the event administered the liquid portion of pentacel without reconstituting with the powder portion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Pt received Td. Began to complain of itching on face and then generalized itching.  Began emergency measures .3cc Adrenaline SC right arm and Benadryl 50mglml 1cc IM right deltoid.  Received O2 per nasal commula. Transported via ambulance to ER.
Information has been received from a medical assistant concerning a 72 year old patient who was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to nursing error. No adverse effect reported. No further information is available.
Some flushing with abrupt headache within 2 hours of vaccination. Started with chills 7 pm 2/1, then presented with chills, aches, dizziness, sweats, fevers to 101.9 through the night and the next day and night.  Today is day 3 temp is down to 99 but still have headache.
After the vaccine 4 hours later I started to hyperventilate.  Woke up next morning throwing up, diarrhea , extreme lethargy,  muscle aches and absolutely no energy. I've missed 3 days of work and I can't get out of bed I'm so sick.  I can't provide for my family in the shape I'm in. I truly need help. My medical doctor told me yesterday all my symptoms WERE VACCINE RELATED
p/vax pt exp vomiting, diarrhea, poor PO intake; seen in ER 2d later for same; admit & d/c x 2 over next 3d w/  dx gastroenteritis & metabolic acidosis; IV hydration & change to Nutramagen
vasovagal reaction; blood sugars dropped; 16 year old patient received an adult dose of VAQTA; This spontaneous report was received from a medical assistant regarding a 16 year old female patient. Information on the patient's pertinent medical history and concomitant therapies were not reported. The patient was reported to be allergic to fish containing products (food allergy). On 05-AUG-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) at a strength of 50 unspecified units with lot # S001832 and expiration date of 12-MAY-2020, intramuscular for prevention of Hepatitis A (antiviral prophylaxis) (product administered to patient of inappropriate age). On the same day (05-AUG-2019), the patient experienced vasovagal reaction (presyncope), and blood sugars dropped (blood glucose decreased) and a candy was given as supplement. Outcome of presyncope and blood glucose decreased was reported as recovered. No product quality compliant (PQC). Causality assessment was not provided by the reporter.