chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive COVID test; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (positive COVID test) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lupus syndrome.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive COVID test). At the time of the report, COVID-19 (positive COVID test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication was reported. It was reported that the patient needed a monoclonal antibody treatment. It was reported that the patient needed infusion No treatment medication was provided.  Company comment- This spontaneous concerns a female patient of unknown age with relevant medical history of Lupus, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred at an unknown time after vaccination with a third dose of mRNA-1273 vaccination. Outcome of the events was unknown at the time of this report. The relevant medical history of Lupus can be a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous concerns a female patient of unknown age with relevant medical history of Lupus, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred at an unknown time after vaccination with a third dose of mRNA-1273 vaccination. Outcome of the events was unknown at the time of this report. The relevant medical history of Lupus can be a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On 10/24/08 pt. presented to office c/o pain L deltoid w/ radiation of pain to elbow.  Area of erythema measured 1.5x2 cm.  Normal remainder of exam.  Redness + swelling resolved but pain to elbow from mid-deltoid persisted.
No prodrome reported. Left-sided chest pain radiating down left arm. ST elevation. Echo normal.
he passed out/fell out during court; covid-19; diarrhea; This is a spontaneous report received from a contactable consumer. A 61-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route at a single dose for COVID-19 immunization. The patient had a history of shortness of breath often, had fatigue, muscle and body ache and headache, loss of taste and smell not that one. People had told her that so many people have died from it from blot clots. She also had a history of irritated bowel syndrome and had these side effects because she went through it anyways. She had a history of anxiety but had not had an attack in a long time. The patients niece broke out in hives (she did not know which vaccine). She had been high step and said that she was a hand washer at a restaurant and once she was done and got home and it started piling up at the end of the day when she layed down. She had heard that people were having heart attacks so must take a baby aspirin. The patients concomitant medications were not reported. After receiving the vaccine she passed out/fell out during court. Some people told her that some costumers died of covid 19 infection. On an unknown date she had covid-19 (she and her husband had covid and both got vaccinated with both shots) and had diarrhea for a month and got over. Someone had told her that they would chip her. The outcome of events was unknown for passed out and Covid-19 and recovered on unspecified date for diarrhea.  Information about the Lot/batch number has been requested.
Patient was given Trumenba to start Men B series and then given Bexsero for 2nd Men B
At 5:02 PM observation RN alerted lead PHN and co-lead PHN via radio call to come to the observation room. Client came in today for his Moderna COVID-19 booster, Lot# 035C21A. Lead PHN and co lead  PHN found client sitting in anti-gravity chair with observation RN at client?s side checking client?s BP.  First set of vitals were taken at 5:05 PM: BP RA - 110/80, HR ? 70, SpO2 ? 96%, client A&Ox4. Client has allergies to shrimp with a known reaction of rash and throat swelling, client reported he needed Epinephrine in the ED roughly 2-3 years ago. Client denied having any medical conditions but does take the medication Hydrocortisone cream for ?my skin outbreaks.? Co-lead asked client to describe how his symptoms began to which client stated, ?I started to feel dizzy 15 minutes into my observation. I was reading the adverse symptoms list in the front of the observation nurse?s desk, and it began to make me feel anxious and I started feeling tightness in my throat.? Client then decided to alert observation RN who then helped transfer the client into the zero-gravity chair. Co-Lead asked to clarify in more detail his throat symptoms. Client denied he had trouble swallowing or breathing and described his symptoms more as ?a small knot in my throat.? Client reported that his throat was not get any worse nor improving since he sat in the zero-gravity chair. Co-lead instructed client to take his mask off and to take full breaths and drink water that was provided by observation Nurse. At 5:10 PM a second set of vitals were taken: BP RA ? 112/98, HR ? 73, SpO2 ? 97%. At 5:11 PM Co-lead recommended to client the administration of Benadryl 50 mg PO once to which client agreed. Co-lead asked client if he can get a ride home, client stated, ?I only live 10 minutes away. It?s just me and my dad that live together. My dad is unable to drive.? Co-Lead then recommended that we would reassess his symptoms at 5:30 PM to see if he felt recovered. 5:15 PM co-lead then advised client to use V-Safe and to f/u with his PCP within 24 hours. Co-Lead re-educated client on the adverse reactions to look out for and to call EMS or go immediately to emergency room. Client verbalized understanding and stated, ?I am starting to feel better.? Third set of vitals taken at 5:20 PM: BP RA ? 106/78, HR 69, SpO2 ? 96%. Client stated, ?I am beginning to feel better.? Client then stated, ?I only got 6 hours of sleep the night before and was up at 6 AM today. Maybe that?s why I had these symptoms after the vaccine.? Last set of vitals taken at 5:30: BP RA ? 110/80, HR ? 69, SpO2 ? 99%, and patient was A&Ox4 and a second water bottle was provided to client. Lead and co-lead walked as standby assist for client (and his father) towards the exit of the HCF at 5:32 PM. Client walked with steady gait.
Patient did not mix the ActHIB component with the DTaP-IPV component prior to administration. Patient  was only given the DTap-IPV components of the vaccine
administered vaccine that was undiluted; administered vaccine that was undiluted; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2022 as dose number unknown (orange cap), single (Batch/Lot number: unknown) at the age of 8 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ERROR (medically significant) all with onset 21Oct2022 and all described as "administered vaccine that was undiluted". Clinical course: Administered to 8 year old male and 6 year old male patients and the vaccine was undiluted. This report is for the 8 year old male patient. The caller has no other patient details to provide at this time. This was the patient's primary dose. The reporter has no product details on hand to provide at this time. Time the vaccination was given was reported as about 1:15 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Overdose", "Product preparation error" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201249386 same product and event, different patient;
I have got a stroke/Ischemic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization. The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "I have got a stroke/Ischemic attack".  Clinical course: Consumer stated that he needed to speak to whoever the doctor was because he had an adverse reaction to the vaccine. He had an ischemic event or ischemic attack was what he believed they call it. He was relatively a healthy man. When paraphrased the concern, consumer stated that he had a stroke there were reports that people might be having strokes as results of the vaccine, he got a stroke.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is patient. I had the ZOSTAVAX injection on 4-28-15, the SHINGRIX 1st dose on 4-25-18. the 2nd SHINGRIX dose on 10-24-18. I had an adverse reaction the next day. I vomited and broke out in a rash throughout my waistline and it traveled to my lower back and buttocks. I itched and itched for 3 weeks until it finally scabbed. During those 3 weeks I was not in any pain, but I treated it with calamine lotion which helped a lot. I took a photo of my bumps and also showed the rash to the nurse practiononer at the Drs office and we both thought that it looked like a mild case of the chicken pox.
At 13:00 (11/06/2003) noted some pain and "warmth" in right upper arm. By 15:00 pain was more intense and it felt hotter (to touch and within right arm as well).  Pain from top of right arm where meets shoulder to middle of forearm.  No loss of feeling or tingling noted. 11/06/2003 @ 16:00: RN Advised patient to apply cold compress, and repeat hourly if she notes improvement from compresses; take per mouth dose Benadryl now, and Ibuprofen/Advil in 1 hour.  Can call this RN At home (# given).  With questions or concerns or call MD/ER if symptoms worsen.  Patient to call health department in AM to update condition.  11/07/2003: Patient called.  Arm remains sore not worse, no redness or swelling.  Will report.  11/10/2003: Patient reports no arm soreness to touch or with movement, no erythema or edema.  RN advised not to take Pneumococcal shot in future and that RN would submit this report as an adverse reaction to the vaccine.
After 3 days of patient receiving the first dose of the Shingrix vaccine, she started to get adverse reactions.  patient is currently experiencing hearing loss on left ear that has not resolved after receiving the vaccine.  Patient also got shingles on left side of the face
Pt stated that he noticed that his throat felt tight and difficult to swallow. He also stated that he was dizzy. We administered 25mg of diphenhydramine orally and monitored until a family member came to get him. He went home and I followed up with him later and he said that his symptoms had resolved
Information has been received from a licensed practical nurse (L.P.N.) concerning an 18-year-old male with allergies to CEFTIN, AUGMENTIN and codeine who thirteen years ago, in "1994", received his first dose of RECOMBIVAX HB, lot number (606566/1552V). Subsequently he developed swelling and tingling of the tongue, wheezing and throat tightness. The patient's mother administered epinephrine and an oral corticosteroid with improvement of symptoms. It it unspecified if medical attention was sought. Subsequently, on an unspecified date, it is reported that the patient recovered. There is no product quality complaint involved. No more information is expected at this time.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in approximately November 2014 (approximately one year and one month ago), the patient had a previous administration of ZOSTAVAX (dose, route and lot# not reported). On 15-DEC-2014 the patient was inadvertently vaccinated with a second dose of ZOSTAVAX (dose, route and lot# not reported). No adverse effects reported. Additional information has been requested.
some dizziness; rapid heartbeat; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 59 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Mar2021 15:30 (Lot number: EN6206) at the age of 59 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: VITAMINS C; VITAMIN D [COLECALCIFEROL]; ELDERBERRY [SAMBUCUS NIGRA]; ZINC. The following information was reported: DIZZINESS (non-serious) with onset 10Mar2021 15:35, outcome "recovered" (10Mar2021), described as "some dizziness"; HEART RATE INCREASED (non-serious) with onset 10Mar2021 15:35, outcome "recovered" (10Mar2021), described as "rapid heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, heart rate increased. Additional information: Patient had no known allergies or any medical condition, stated she was healthy. She was also taking multivitamins. Patient did not receive any other vaccine within 4 weeks prior to vaccination. After dose 1, she experienced some dizziness and a rapid heartbeat within about 5 minutes of getting the dose. The symptoms went away within about 20-25 minutes with some rest and a cold compress on her head at the vaccine site. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441702 same patient/drug, different dose number/events
Lethargy; no energy; stomach upset; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), ASTHENIA (no energy), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LETHARGY (Lethargy), ASTHENIA (no energy), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (Nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 03-Mar-2021, LETHARGY (Lethargy), ASTHENIA (no energy), ABDOMINAL DISCOMFORT (stomach upset) and NAUSEA (Nausea) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported Treatment with Ibuprofen was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: TCR form-NNI
Pt reports symptoms starting roughly 48 hours after administration.  Pt states right sided facial abnormalities.  Pt states she cannot wink the right eye but can shut the eye when she blinks normally with both eyes together.  Pt also states right sided weakness and paralysis of mouth, says she has to drink out of the left side of her mouth only or else she spills on herself.  Pt states this started on Sunday morning  03/28/21 and has progressively gotten worse every day since.  I advised the pt that this could possibly be Bell's Palsy from the COVID vaccine that I gave her on 03/26/21.  I told her to call her rheumatologist but she said she no longer has one.  I advised the pt to call her primary care physician and they would be able to advise the best course of treatment.
pt recv vax 18APR96 & exp tenderness in thighs & rt ankle;23APR96 limping-rt ankle-worse;24APR96 started Advil;
Patient's husband called about reactions after the vaccine as patient does not speak english. She experiencing trouble breathing for the whole week and feels very tired. Also reports swelling and pain in the legs and hand, significant enough to prevent her from removing her wedding ring. I recommended them to go to the emergency room as soon as possible as her symtoms resemble a possible clot. She does not have a PCP to refer her to nor does she has insurance. He agrees to take her to the emergency room.
Bell?s Palsy on right side of face. Numbness acute for one month, then quieted somewhat, but still enough to be troublesome. From lips all the way up to the top of the skull.
The 10 year old patient received the pediatric Pfizer vaccine. The dose was administered without issue but during the waiting period after (approximately 5 minutes after administration), she got light headed and fell off her chair and bumped her mouth. The patient has special needs and is a non-verbal communicator but she did not appear to have any trouble breathing and no swelling was seen. After a few minutes, the patient was able to sit up and after 15 minutes was able to walk with her mother and appeared to be okay.
7 day post immun, pt reported a red arm. Seen by MD dx Cellulitis. Tx Keflex & warm compresses at inject site.
Mom states pt had persistent screaming lasting over 3 hrs; no fever; states pt had APAP every 4 hrs p/vax recvd for 24 hrs; p/3 1/2 hrs pt was calm; no other problems; mom called MD;
Itch; Hives on back intermittent; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch) and URTICARIA (Hives on back intermittent) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ENALAPRIL for Hypertension, SITOSTEROL (BETA SITOSTEROL) for Prostatic hyperplasia, MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Itch) and URTICARIA (Hives on back intermittent). At the time of the report, PRURITUS (Itch) and URTICARIA (Hives on back intermittent) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow Up:Follow-up was received on 1 Apr 2021 with the addition of mail ID.; Reporter's Comments: This case concerns a 78-year-old male who experienced NS expected events of intermittent urticaria and pruritus on his back. The event occurred 8 days after the first dose of mRNA-1273. Treatment included Cortisone cream, Beta Sitosterol, Tylenol. Event outcome not provided. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
1st dose 2019, wants to continue the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received first dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2019, wants to continue the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 7-Apr-2023 A pharmacist called in to report that a patient wishes to continue the vaccine series for the Hepatitis B vaccine. The reporter did not know the age of the patient at the time they received the first dose, did not know the brand, nor place of the vaccination. The call was escalated to second line. The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Hepatitis-B, which led to incomplete course of vaccination.
Fever, severe headache, muscle weakness, no  Strength to stand, vomitting, swollen left eye, rashes on abdomen.
Patient was given Tdap right deltoid on 6/23 phoned this AM to say over weekend was awoke from sleep with sharp pain in that deltoid and was red and raised by Sunday. Had rash encompassing arm from shoulder to wrist. Used Benadryl with good results but wanted us to know it was terrible pain at the time.
Patient felt faint after vaccine was administered right away. She reported arm pain the day after immunization to the pharmacy on 9-5-13.
2nd moderna shot to on day 22 after the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd moderna shot to on day 22 after the 1st dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 004B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd moderna shot to on day 22 after the 1st dose). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd moderna shot to on day 22 after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX Lot# K008823, expiration date 19-JUN-2016; Lot# K011800, expiration date 21-AUG-2016; Lot# K021935, expiration date 10-NOV-2016; Lot# K16129, expiration date 23-SEP-2016 and Lot# L002217, expiration date 21-JAN-2017, (route and anatomical location were not reported). There was no concomitant therapy reported. No adverse effect was reported. This is a linked case with 1506US010763 from the same reporter. Additional information has been requested.