chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he tested positive for COVID a week ago; he tested positive for COVID a week ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "he has leukemia" (unspecified if ongoing), notes: He has 3 doses of the vaccine but produced no antibodies on him because he has leukemia. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he tested positive for COVID a week ago". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: He tested positive for COVID a week ago on Thursday; negative, notes: He took a COVID test and resulted negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Caller is a patient. On call the patient stated that he recently finished a course of Paxlovid and wanted to know if Paxlovid produces COVID antibodies after completing the treatment. Caller stated I thought you might like to follow up on my experience and stated that he tested positive for COVID a week ago on Thursday and took the five day course of Paxlovid and then he took a COVID test and resulted negative. Caller mentioned that in that sense the drug worked for him, with no side effects, that it was easy to take and ended up with a Thanks Pfizer. Caller also mentioned he has 3 doses of the vaccine but produced no antibodies on him because he has leukemia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In May 2017, at approximately age 71, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at an urgent care center for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Swelling, pain and itching at injection site (3"x2")  Started a few hrs after injection and still persists
The first thing that happen was I had a warmful pain sensation in the back of my neck and it travel around my body, This was eight minutes after the vaccine. After this the bottom of my right foot went numb and so did the left bottom foot this traveled around my body. My neck also became very painful like  a burning sensation. I was not able to work or exercise this went on for some time. My pulse went really high it went up 135bpm , and I had a virtual emergency room visit. The painful inflammation from the back of my neck to my head lasted for about two months. And I have had lots of muscle weakness. My gallbladder has fail and I have had trouble swallowing I was diagnosed with polycystic.
rash all over body; Mottled skin; generalized rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, less than a day after receiving Shingrix, the patient experienced red rash, mottled skin and generalized rash. On an unknown date, the outcome of the red rash, mottled skin and generalized rash were recovering/resolving.   It was unknown if the reporter considered the red rash, mottled skin and generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix and by evening of same day she broke out into a rash all over her body. Stating solid red rash on both her upper arm on the elbows and mottled rash on the rest of her body. The patient stated it was beginning to decrease a little now. The reporter did not give consent to follow up. The patient would not provide additional information to complete this adverse reporting. The patient stated she would report it directly to the Centers for Disease Control.
Patient complained of numbness/tingling to lips after receiving vaccine. Was monitored for 30 minutes by provider and symptoms resolved.
12/06/21 presents to ED for "weakness and numbness in his right hand". PMHx of "paroxysmal A-fib s/p ablation" "hypertension".
DVT in right calf. Pain, no redness or swelling. Pain felt first on Thursday morning, then went away. Pain came back throughout Saturday. Slept with leg elevated Saturday night, but woke up from the pain on Sunday. Couldn?t put weight on right leg. Went to the ER two hours later, though pain had receded a bit. D-dimer test revealed elevated clotting factors. Ultrasound revealed extensive clot in calf.
Patient has received an expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HBV (Engerix B) (batch number 9KG74, expiry date 9th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th June 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 24th June 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The office manager reported that a dose of Engerix B was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Engerix B dose which was already expired on 9th May 2022, which led to expired vaccine used.
I got the Moderna COVID vaccine booster (12/13/21) in left arm and flu vaccine in right arm. Arm pain at injection site was initially the same. This initial pain went away in both arms after 5 days. To date (1/11/22) the left arm injection site hurts when under pressure (sleeping on side, or bearing body weight on arms e.g. plank exercise), left side also has the sensation of pins and needles in shoulder and in fingers that comes and goes.
5/10 Received Hep A  and YF, started feeling achy in the afternoon. 5/11 still not better, on 5/12 still with achiness, stiff neck, sore throat and slight stuffy nose. No fever.
@ inj site-red whelp started noc p/shot puffy, swollen 3" to 4" diameter-itchy-x 5 days;
Within three hours of receiving the vaccine, patient's left arm became very stiff and painful.  Any movement caused shooting pain through the arm.  Range of motion was severely limited for four days following, after which pain started to lessen.  Patient recovered full range of motion after four days.  Dull ache in the upper arm is constant, with sharper pain resulting from any weight bearing movement.  Tingling runs down the arm into the left hand, particularly after a lot of use.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The vaccine doses were exposed to an unspecified temperature excursion for an unspecified time; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1705USA012266: US-009507513-1705USA012267: US-009507513-1705USA012269: US-009507513-1705USA010555:
Information has been received from a medical assistant concerning a patient who administered a first 0.5ml dose of HPV VLP vaccine (yeast) (lot # 660391/0063X) intramuscularly to a patient on 25-OCT-2010, which had expired on 19-OCT-2010. No adverse effect reported. Follow up information has been received from the certified medical assistant who reported that the 14 year old female patient was vaccinated with the first 0.5 ml dose of HPV VLP (yeast) (lot # 660391/0063X) intramuscularly into right deltoid. The reporter also mentioned that the event did not require ER/doctor visit. Information has been received from a social media site regarding a female patient. The patient told her story regarding GARDASIL on a social media site. No further information is available.
Headache, Myalgia Flushing, Swollen tongue 5 days post vaccine
Left side numbness of face, headache, nausea and itching. Went to employee health.
pt recv vax 3NOV97 & 18NOV97 pt exp painful & swollen fingers, knees, wrists & feet;pt also exp nausea;pt was then seen by MD & dx w/arthritis (knee) & HTN;
J&J Dose 5/20/21 (203A21A) COVID Positive 1/3/22  1/3/22: Patient is a 72-year-old female with no known past medical history presented to the ED with left hip pain.  Patient reports she was coming out of her shower 3 days ago she tripped and fell. Patient denies any associated head trauma or loss of consciousness. Since then patient has been having persistent left hip pain. Patient reports he does not take any medication. Patient denies starting any new medication. Patient denies any recent sick contacts. Patient denies drinking alcohol. Patient denies any change in her urine color. Patient denies any fevers/chills, chest pain, shortness of breath, nausea, vomiting, diarrhea, abdomen pain, dysuria, headache or dizziness. Patient has no known liver disease. In the ED temp 98.2°, heart rate 102, R 18, 98% on room air, blood pressure 152/87. Chest x-ray negative. Pelvic x-ray did show a left sub-capital femoral neck fracture. CT abdomen showed non-obstructed ventral hernia and cholelithiasis without cholecystitis. CT head negative. Lab work significant for potassium 3.0, ALT 88, AST 107, ALP 1353, T bili 4.6, albumin 3.7, ammonia 24, lipase 26, acetaminophen level less than 5, alcohol level less than 10, WBC 4, lymphocyte 1.07, INR 5.5. ED provider did consult with GI who recommended discussing case with the Specialist. Recommendation at the "Private" was to reverse INR continue to monitor. No acute intervention required. Patient did receive 2 units of FFP and vitamin K 5 mg p.o.. Per staff patient's son who lives next door to her has COVID at this time. 1/7/21: patient presented following a mechanical fall and sustained a left femoral neck fracture. Further work up had shown acute hepatitis A and COVID -19 positive test, but the patient did not have any respiratory symptoms. She underwent left hemi-arthroplasty. She is currently doing fine cooperating with PT/OT. She will be discharged to SNF for further conditioning.
Pt received 2nd dose of Pfizer today. Pt was in post observation an reported feeling nausea. Pt moved to cot with emesis bag. Aid called for further evaluation. Pt sitting up and reported having HA in the back of her head. Pt reported to medics that she was feeling better and was able to drink water. At 12:05 Pt cleared by EMS safe to drive home. Pt advised to f.u with PCP regarding elevated BP.  VS 1200 per EMS BP 148/104 HR 98 O2 Sat 100% on RA  VS per EMS 12:15 BP 168/104 HR 96 O2 Sat 97% on RA
Vaccine administered at 0900 on 01/02/14. Reports started to feel ill at 1300. "I was very, very, ill last evening, I threw up, had a fever of 100.5, diarrhea, aches and pains and chills. I felt like I had the flu. I was fine by midnight. Same thing happened last time I got it too".
Case was vaccinated and boosted by August 2021, then was hospitalized for Covid in January 2022 Admitted to Medical Center. Symptoms: Runny nose and sore throat, N/V/D, poor appetite. Treated for Acute respiratory failure and Covid pneumonia. Treatment included: Dexamethassone, Remdesivir, Oxygen, Lovenox for DVT prophylaxis  Discharged to home.
More vertigo than before; weak-knees buckling.; brain fog/ HAZY MIND; dry tongue; dizzy; weakness/difficulty standing up; cough; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (weak-knees buckling.), FEELING ABNORMAL (brain fog/ HAZY MIND), TONGUE DRY (dry tongue), DIZZINESS (dizzy) and ASTHENIA (weakness/difficulty standing up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 024A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus infection (get these infections every winter), Bronchitis asthmatic on 02-Apr-2020, Pneumonia, Vertigo in October 2017 and Sinusitis from 22-Mar-2021 to April 2021. Previously administered products included for Infection: ANTIBIOTICS. Concurrent medical conditions included Allergy NOS (Ccocky , sneezy, environmental allergy since 1990.) and Pollen allergy. Concomitant products included HYDROCHLOROTHIAZIDE for Elevated BP, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for Macular degeneration, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ALBUTEROL SULFATE and AZELASTINE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ARTHROPATHY (weak-knees buckling.), FEELING ABNORMAL (brain fog/ HAZY MIND), TONGUE DRY (dry tongue), DIZZINESS (dizzy), ASTHENIA (weakness/difficulty standing up) and COUGH (cough). On an unknown date, the patient experienced VERTIGO (More vertigo than before). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Antihistamine therapy, at an unspecified dose and frequency. On 16-May-2021, ARTHROPATHY (weak-knees buckling.), FEELING ABNORMAL (brain fog/ HAZY MIND), TONGUE DRY (dry tongue), ASTHENIA (weakness/difficulty standing up) and COUGH (cough) had resolved. At the time of the report, DIZZINESS (dizzy) and VERTIGO (More vertigo than before) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 28-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) punctate foci of cerebral white matter T2/ Flair Hypersensitivity, appearance non specific but may reflect mild to moderate chronic microangiopathic changes. Rest MRI normal..         Treatment medications include Steroids.   This case was linked to MOD-2021-139676 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Patient demographic, Medical history, Lab data, Concomitant medications, treatment medications added. Events outcome updated.
I became nauseated; Had a headache that wouldn't let up; Fatigue; Muscle and joint pain; Muscle and joint pain; chills; Hot flashes; I was ill and bedridden for 26 hours; I was ill and bedridden for 26 hours; I am asthmatic; had trouble breathing in; vaccine location:Left leg; Dizzy spells; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0167) via an unspecified route of administration in leg left on 01May2021 at 09:45 (at the age of 31 years-old) as dose 2, single for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Patient medical history included covid-19 (covid prior vaccination: Yes), asthma, hypoglycaemia, hypothyroidism, irritable bowel syndrome, endometriosis, known extensive allergies, Fruit allergy, nature allergy. The concomitant medications included levothyroxine (LEVOTHYROXINE) taken as 50 mcg 1x daily for an unspecified indication. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration in right arm on 10Apr2021 at 09:45 (at the age of 31 years-old) as dose 1, single for COVID-19 immunization and reported that minutes after dose 1 she became severely nauseated and had a bad headache. On 01May2021 at 22:00, the patient experienced "i became nauseated", had a headache that wouldn't let up, fatigue, muscle and joint pain, chills, hot flashes, i was ill and bedridden for 26 hours, I am asthmatic, had trouble breathing in, dizzy spells on 2021, vaccine location:left leg (product administered at inappropriate site) on 01May2021 09:45. The patient was was put on watch for an hour before being released. The patient previously taken NSAIDS and experienced allergy. The vaccination facility type was reported as hospital. No other vaccine in four weeks. The covid was not tested for post vaccination. The patient experienced 10 hours after dose 2 she became nauseated, had a headache that wouldn't let up, fatigue, muscle and joint pain, chills and hot flashes. she was ill and bedridden for 26 hours. She was asthmatic and also had trouble breathing in with second dose. A week after she was beginning to get dizzy spells and those are still occurring. The vaccine was administered at left leg. No treatment received for the adverse events. The clinical outcome of all events was not recovered.    No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 23Mar2021 15:00 at the age of 59-years-old as dose 1, single for covid-19 immunisation at Hospital. Medical history included treated for breast cancer from an unspecified date in 2019. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 02Apr2021 at 16:00, the patient experienced chills, body aches, low grade fever and loss of taste. The clinical course was reported as follows: After 10 days from her first vaccine, the patient had the chills, body aches, Low grade fever and the loss of taste. No treatment was received for adverse events. Adverse events resulted in none of the above. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated she had no reaction to first shot received. However with second dose she had redness and swelling at injection site, soreness of arm, flu-like symptoms, stomach pain and upset, and panic attack. I confirmed with patient that there were no anaphylactic symptoms, no shortness of breath, trouble breathing, throat closure, rash, dizziness. she confirmed did not experience any of those side effects just ones mentioned. She is feeling slightly better still has stomach upset and some soreness in arm.
Pt. developed petechiae of lower extremities below knees. (R) greater than (L). These areas appeared within 48 hours of vaccinations. No squeezing or other trauma to involved area. Vaccines given in thighs above. No associated fever or other illness.
Employee said approx 1 week after injection, she was exiting the elevator at work and her left leg "stopped working". Shortly after this, her left arm "stopped working". She sought medical attention with a neurologist who performed numerous tests and found no cause. He attributed the anomaly to her vaccine.
IM DTaP delivered by Bioject (needleless) device in left deltoid. Approximately 8.5 hours later pt complained of arm hurting. Seen the next day with redness, warmth, swelling about 8 x 12 cm (non-tender) on left deltoid (seen by MD and dx as "Arthus type" reaction.
(R) arm pain/discomfort, redness/streaking at inj site spreading to axilla and breast area.
After the vaccination, I had swelling and redness at the injection site. I also had on top of my right hand, lumps. They did go away the next day. After few days I started to have inflammation of my joints, muscle aches, pain, and stiffness on all of my joints, and nausea. Now I'm to the point that I have to have assistance walking. The doctor prescribed for me some prednisone pack and muscle relaxers.
Patient had redness and swelling about 1 to 2 inches around injection sight 1-2 days after vaccination
High fever over 101 sometimes over 104 lasting over 5 days after vacciation. 6 days after vaccination and still running fever.
10:15 Tdap given in right arm. 11:30 Student returned to office c/o generalized itching of neck and shoulders. Visualized area to be bright red in color with welps. Called mom. 3tsp. benadryl given PO. 11:40 B/P 100/60 P80 R20. 11:50 c/o throat, mouth, and lips being numb. 911 called. First responder arrived. B/P 110/80 P80 R20. Mom arrived. 12:15 Paramedics arrive.  Pt left in ambulance to hospital for observation. 2:00 mom called school child D/Ced from hospital.  He is to go to PMD tomorrow for follow up.
Pt was seen 8/29 for 4 yo well visit.  Given DTaP and MMR. On 8/10 parents reported significant swelling of thigh at DTaP site, (+) erythema. No fever, given ibuprofen & BENADRYL. Seen in office 8/31. Thigh was still swollen and rash had spread to cover every entire circumference. Measurements of thigh: 0.4 cm left --> 28 cm on right. Lower thigh was (L) 27 cm, (R) 31 1/2 cm - Dx: Extensive limb swelling Rxn to DTaP.
Pt recvd 1st dose of Hep B on 9JUL91; next day pt devel a petechial rash on shoulders & mid-chest area; Pt was seen in ER as required by hosp policy; Pt later recovered;
Patient arrived for nurse visit for HPV #3, after receiving first two doses without any problems. Today, about 2-3 minutes after receiving vaccine - patient had a tonic-clonic seizure lasting about 15 seconds. Last, and only seizure was 4 years ago. Patient not on any medications. Patient monitored and 911 called - to ER.
pt recv vax & mom stated pt had sz @ home taken to hosp by ambulance;had another sz in ER; dx ear infect; t<103 ax; exp sz w/fever 4SEP;pt non-responsive & had labor resp;exp cardiac/resp arrest;vomiting, glazed
Pt arrived for second dose Moderna.  Pt did not have his card.  LVN stated she checked his Health Record. Health Record states Moderna 1st dose given.  LVN administered Pfizer (she was solitarily administering Pfizer that day).