chrisvoncsefalvay/vaers-outcomes huggingface dataset:
malaise; I do a lot of outside work and the first one kept me not doing anything for three days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "I do a lot of outside work and the first one kept me not doing anything for three days"; MALAISE (non-serious), outcome "recovered", described as "malaise".  Additional information: It was reported that the patient was energetic prior to vaccination. Malaise just got up and went away. Patient was afraid if the second dose will put him down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a report from a study. A 15-year-old female subject received blinded study vaccine (meningococcal group b rlp2086/hepatitis A virus vaccine) on 07Jun2013 at 17:12 and presented with event acute anaphylactic reaction on the same day at 19:55. The reported subject's medical history included allergy to KEFLEX, Beta thalassemia minor tract, anxiety and depression. Concomitant medication included ZOLOFT. On 07Jun2013 at 17:12, the subject received her first dose of blinded study vaccine (meningococcal group b rlp2086/hepatitis A virus vaccine) intramuscularly in her left arm. No acute reaction occurred within 30 minute. The patient stated she felt fine and was discharged at 17:45. She then went straight home, didn't eat or drink anything and was not exposed to anything unusual. On the same day, around 19:55, 40 minutes prior to hospital Emergency Room arrival and 2 hours and 45 minutes after vaccination, the patient complained of lip swelling, heart racing, chest hurting, stomach ache with nausea. At 20:35, in the ER, the patient was found with upper lip slightly swollen, tachycardia, palpitations, chest pain, headache, tingling in hands, abdominal pain and nausea. Physical exam in the ER was notable for no respiratory distress. Vital signs on presentation: blood pressure (BP) 138/88 heart rate (HR) 140 20 respirations per minute, Temperature 98.4F. O2 Saturation was 99%. Repeat vital sings in the ER included BP 100/58, HR 95 at 22:00 and BP 106/57 HR 97 at 23:30. EKG indicated sinus tachycardia with a rate of 140 beats per minute. Relevant laboratory tests included WBC 23.3k/ul with neutrophils 85.1% and Lymphocytes 7.0%, normal serum chemistry, C-reactive protein 6.00 mg/dL, Serum albumin 5.2 g/dL, Rapid Influenza A and B negative, Rapid strep A test negative and Urinalysis was 4+ blood with leukocytes. The patient was treated with BENADRYL at 20:55, SOLUMEDROL at 21:10, ZANTAC at 21:12, all per IV and was put under cardiac monitoring. The patient was discharged home from ER on 08Jun2013 at 00:41. Upon discharge she was noted to be without pain with skin warm and pink. Discharge vital signs were BP 98/49, HR 95, RR 29, Temperature 98.4F, O2 Saturation 97.7. (Baseline BP in April 2013 was reported as 102/74). The patient was discharged on oral prednisone 40 mg for 5 days and diphenhydramine 25mg orally as needed. The subject received the first vaccination dose at visit 1, and then was withdrawn from the study prior to receiving any further vaccinations, so they did not complete the immunization schedule. The investigator considered the event acute anaphylactic reaction serious life threatening, and related to study drug but not related to clinical trial procedure and concomitant drug. On 14Jun2013 the blind code was broken by the Sponsor due to serious, related, unexpected event. Follow-up (31Oct14): new information includes: action taken changed from not applicable to permanently withdrawn. Follow-up (21Nov2014) New information includes: additional relevant lab tests from 07Jun2013.
Patient was given second dose of covid vaccine 14 days after dose 1. Dose 2 should have not been given until 21 days after dose 1.
Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM:   1447 patient arrival, per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506
got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick".  The lot number for bnt162b2 was not provided and will be requested during follow up.
5 to 7 days after the vaccination the vaccination site became itchy and pink Circle. It would come and go but mostly staying. It is a little warm to the touch. No lump and doesn't hurt. Went to my primary care doctor this morning and she wants to see me again tomorrow and she is checking with the pharmacy about this and she asked that I report this to you.
At the same time, I took Shingrix on the left arm and Flu shot on the right arm. The Shingrix shot hurt during injection, and the left arm had sored shortly after injection. Side effects are:  1. Fever of 100 - 102 and feeling very cold:  staring from 10-11 hours after injection, lasting approx. 12 hours 2. Muscle ache all over body:  starting from 10-11 hours after injection, lasting approx. 24 hours 3. Having to lie in bed, feeling thirsty despite drinking lots of water, fatigue:  starting at the same time, lasting approx. 14 -20 hours 4. Couldn't dress myself, couldn't even gently touch the injection site due to sever pain in the left arm:  starting at the same time, lasting approx. 48 hours 5. Moderate but persistent pain in the left arm, couldn't lift up the arm:  lasting approx. 4-5 days
pt here to received first dose of covid vaccine. pt is 23 months old. Instead of receiving 0.25 ml of Bivalent (6 months+) (Dark Blue Cap / Gray Border), pt received 0.2 ml of Bivalent (6 months - 5 years) (Dark Pink Cap). pt stayed in observation for 15 minutes. per mom, pt was feeling fine.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse via social media and refers to a child of unknown age. No medical history, concurrent conditions, concomitant medications or past drugs were reported. Approximately in 1996 (reported as 20 years ago), the child received M-M-R II (vaccination details, lot #, expiry and dosing details not reported) for prophylaxis along with many other vaccines at one time. After receiving the vaccines, the child became very ill and developed autism. At the time of this report, the outcome and causality of events were unknown. No product quality complaint (PQC) involved. Upon internal review, autism was determined to be medically significant. Additional information is not expected as the reporter did not wish further contact.
One day I had extreme join pain in the knees almost unable to walk followed in the evening by exhaustion and very strong fatigue. I had to lay down. It was a little bit better in the morning after sleeping. My nose started running with fatigue still. Unable to think straight. The doctor noticed I was coughing a lot and prescribed strong cough medicine for me. It has been ongoing for 10 days although I'm feeling a lot better. I had a telehealth interview with my doctor on Monday afternoon 12/19/2022. I started my first dose of PAXLOVID on the evening of 19th. I also only have one kidney so I got renal PAXLOVID.
The same day 2/9 she began with a sore arm.  At the injection site she stated that it became itchy after the vaccine but resolved fairly quickly.  on 2/10 she had a lot of pain in her arm at the injection site.  She was at work and began to feel like she was going to pass out.  After that she started with nausea and feeling hot.  she left work at 1049
Less than one minute after receiving anthrax #1 and 2, she had very brief episodes of chest pain, lasting less than 2 min that resolved without intervention.  Chest Pain Start: 01/08/2008 Comment: brief, 3/10
Patient tolerated well at the time of documentation. Patient will wait for 30 minutes due to history of severe reaction to PCN during childhood. Patient scheduled for second dose on June 25, 2021  At 11:47 (12 minutes post injection) patient started experiencing dizziness. Patient stated he's diabetic and did not take his medication morning or eat this morning. Blood sugar checked - 200. another HCP came to evaluate patient. Pt declined snack and declined to lie down. Patient given 25mg Benadryl at 12:00pm  At 12:05pm Patient stated dizziness very slightly improved. Patient offered and accepted snack. Will continue to monitor.  12:10pm B/P 157/82, HR 64, SPO2 97% on RA, RR 16  12:20pm Patient stated he's feeling much better have eating snack and drinking water. Patient stated "it's there a tiny bit".  12:35pm Patient ambulated to restroom, unassisted, steady gate. Patient stated he's now "feeling great!"  12:45pm Updated the doctor that patient states he feels great. No dizziness, ambulated to restroom with steady gate. Doctor stated patient could leave since symptoms have resolved and wanted patient reminded to have his labs done. Patient stated since he's currently unemployed, his funds are restricted, but will get them done as soon as he can.  12:50pm Patient ambulated to exit with steady gate
No Adverse Event; administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.) and NO ADVERSE EVENT (No Adverse Event) in a 70-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.).    No concomitant medications was reported. Dosage text of suspect Spikevax Bivalent was reported as Additional booster. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716324 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716324:Same Reporter
This case was reported by a healthcare professional and described the occurrence of itching in a 28-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  The subject's medical history included seasonal allergy. On 30 September 2009 at 09:30 the subject received unspecified dose of FLULAVAL (unknown, left arm).  On 30 September 2009, less than one day after vaccination with FLULAVAL, the subject experienced itching, erythema and inappropriate route of vaccination.  It was reported the nurse inadvertently gave vaccine intradermally and the subject reported itching and redness.  The healthcare professional considered the events were disabling.  At the time of reporting the erythema and itching were unresolved.  The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Redness, pain, and swelling from top of arm to elbow. Redness has increased but pain and swelling have decreased since onset.
PATIENT IS ONLY 57 YEARS OLD AND RECEIVED HIGH-DOSE FLU VACCINE.
Pt developed hives and itching all over her body. Physician advised her to take Benadryl and contact office if condition worsened.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 17Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma and rebounding; "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "recovered" (2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. The patient was treated with Paxlovid from COVID-19 from 01Jul2022 to 06Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer. A 66-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection,Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 19Feb2021 09:00 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No covid prior to vaccination. No covid diagnosed post vaccination. No known allergies. No pregnant at the time of vaccination. The patient experienced blisters on hands and feet on 21Feb2021. Cream to use on infected as treatment. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of maladministration (asymptomatic/child too young) in a 1-day-old male subject who was vaccinated with INFANRIX, (GlaxoSmithKline). On 28 April 2014 the subject received 1st dose of INFANRIX (0.5 ml, unknown route) instead of 1st dose of ENGERIX B, which led to a maladministration (asymptomatic/child too young). No adverse event ha been reported.
one week after vaccine (no adverse events during this week) vaccine site started to itch and was reddened, swollen (a knot could be felt at the muscle). The redness wasn't rash like - but was warm to touch. 36 hours later (now- at the time of this report) my arm is not swollen, but there is a slight redness about the size of an orange- no more itching or soreness. I did use some topical cortisone cream on the site to manage the itching.  Otherwise- I am fine- I just wanted to report this symptom.
Immediate localized swelling at the injection site about the size of a small grape.  Provided the patient diphenhydramine 50mg to treat the localized reaction.  Monitored the patient for 30 minutes and she left in good health accompanied by her husband
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, concomitant medications, height, weight and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Apr 10, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient had blurred vision for 3 days. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered.
Headache, muscle pain, 102 degree temperature for approximately 12 hours. Nausea for 2 hours.
I'm fully vaccinated. I took 2 doses and 2 boosters, the last one was one month ago. On 04May2022 I tested positive for COVID-19; I'm fully vaccinated. I took 2 doses and 2 boosters, the last one was one month ago. On 04May2022 I tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (003110). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (COMIRNATY), on 12Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6205), on 29Oct2021 as dose 3 (booster), single (Lot number: FG3527) and on 19Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "unknown" and all described as "I'm fully vaccinated. I took 2 doses and 2 boosters, the last one was one month ago. On 04May2022 I tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: She tested positive for COVID 0May2022; (May2022) unknown result, notes: It was sometime the week of 10May2022 -12May2022; (19May2022) Positive, notes: However today I again tested positive after feeling pretty lousy. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid. Clinical course: The patient first tested positive on 04May2022, patient did not took paxlovid immediately and the following week she was not feeling well again so she tested herself again. She doesn't know which day. It was sometime the week of 10May2022- 12May2022. After that, was when she took Paxlovid. Her son recommended it, and sent her a box of it. She took the doses of it at home. Since, then she took the doses as recommended, and she came back to withheld where they stay for the spring, summer and fall. She doesn't have any of the Paxlovid left over. She took it 5 days. Then, later caller said she thinks the treatment was three days and seemed to recover after a relatively mild case. Three days ago, she was not feeling good. They still had test kits so she took one, and tested positive today (19May2022) after feeling pretty lousy. Her husband tested negative. He has medical issues, and he was high risk so she has stayed away from him. This has been the last 3 days. How long will she test positive for? The patient wanted to know does Paxlovid provide any extended immunity? Or can patient expect a continuing repeat of this? Was this the same infection or a reinfection? She hope it's not a false positive.
Pt vaccinated with DTP developed papular rash 3-4 hours later.  Next morning, rash spread to cover 5"X7" area.  Denies other normal or ADR's.  Rash is on L. thigh only.
painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nausea vomiting shortness of breath headache some periods of confusion
syncopal event. 911 was then called. Once EMS arrived he was found unresponsive and was in V fib.; transferred to the cath lab where he was found to have a proximal LAD occlusion deceased 3/17/2021
Fever, chills, nausea, sore throat, headache, extreme body aches and cough. Fever elevated  longer than 3 hours at 100.4. Had rapid heartbeat which happened about three times. Slight difficulty breathing.  Had Covid 19 about a month ago and felt like she was having it again.
sore arm for 3 days. I have a psoriasis flare up in areas I dont normally have flare ups in. I also have an arthritis flare up
hair started falling out in August 2021; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair started falling out in August 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Drug-Lisinopril  reaction-cough) and Sulfonamide allergy (Drug-Sulfa drugs).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ALOPECIA (hair started falling out in August 2021). At the time of the report, ALOPECIA (hair started falling out in August 2021) had not resolved.            Patient never had diagnosis of COVID-19 and states that he was very healthy.  Patient took Booster dose: 22Dec2021 Lot 045J1A  Patient visits dermatologist once a month  Concomitant medications details were not reported by the reporter. Treatment details includes Steroid injections and antibiotics .