chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered to 2 patients from a vial that was post temperature excursion.; Vaccine administered to 2 patients from a vial that was post temperature excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to 2 patients from a vial that was post temperature excursion.) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients from a vial that was post temperature excursion.) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 008B21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (Codeine).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 11-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to 2 patients from a vial that was post temperature excursion.) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients from a vial that was post temperature excursion.). On 11-Nov-2021, PRODUCT STORAGE ERROR (Vaccine administered to 2 patients from a vial that was post temperature excursion.) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients from a vial that was post temperature excursion.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received on 16-nov-2021 and contains Patients race information, patients allergic substances, medical history and booster doses route of adminstration, lot number and date of administration.
itching rash on several areas of his body including his head, middle of his back,  under his left arm pit, stomach and groin area. Says his mouth feels and his "tongue thick."  Veteran denies any shortness of breath or chest pain.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech,; This is a spontaneous report received from 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 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022, outcome "unknown", described as "Vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Proprietary medicinal product name: Pfizer.Indication for use in the case: Treatment of COVID-19. Date of start of drug on 25Nov2022. Date of last administration on 25Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she was sick with Covid even though she had the vaccine; she was sick with Covid even though she had the vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication(s) included palbociclib (IBRANCE) taken for malignant neoplasm of upper-outer quadrant of left female breast.  The patient experienced sick with covid even though she had the vaccine on an unspecified date with outcome of unknown.    The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Rash around injection site after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around injection site after 1st dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash around injection site after 1st dose). At the time of the report, VACCINATION SITE RASH (Rash around injection site after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Vaccine given and pt noted to have seizure like activity immediately after. Lasted ~20 seconds. Eyes rolled back, jerking of arms, and feet flexed. After episode pt alert and oriented x3. No s/s respiratory difficulty. Pt did not recall episode.BP stable. Reports pt with no food this am. Took ATARAX PRN as prescribed by MD for anxiety r/t vaccine. Hx of fainting with vaccines. Per mom pt has never had seizure like activity before. Had 2 seizure like episodes after vaccine (first immediately after and then 20 minutes later when attempting to sit up again).
Numbness and tingling in the arms and hands.   Pain and pressure near the heart and lungs.  No treatment has been given.  Symptoms still continue as of 5/23/21.
This is a spontaneous report from a non-contactable consumer. A 63-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration, unspecified anatomical location on 16 Mar 2021 (at the age of 63-years-old) as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021, the patient had "fatigue, diffuse pain and diffuse pain (including eyes)". No therapeutic measures were taken for events. The clinical outcome of fatigue and diffuse pain and diffuse pain (including eyes) was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Country was added. For suspect vaccine, "Unknown" removed from Lot# field. Event "pain in eyes" updated as "diffuse pain (including eyes)" for "Description as Reported". "None" removed from "Concomitant Therapy" field since only "if other vaccine in four weeks: No" reported, not mention in took any drug. Final sentence "Batch/Lot number cannot be obtained. No follow up attempts are possible. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." per SER055. Leading sentence "This is a spontaneous report received from a non-contactable other non-health care professional" updated as "This is a spontaneous report received from a non-contactable consumer." Initial information need review: adverse_event: Fatigue and diffuse pain (including eyes)
"pt recv vax 9JUL96 & pt exp fever, tiredness, an eye itch, a rash near the nose & approx 50 lesions;"
I experienced redness and warmth to my arm after receiving the flu vaccine. this was of extra concern because it covered a much larger portion of my arm than the previous year.
Patient says that the following day he felt aches and pains, sniffles, and sinus dripping.  Four days after the vaccine (10/11/11), the patient had elevated blood pressure to 160/100.  He was seen at Hospital, where the doctors felt that it could have been secondary to the vaccine.
We now get many of our vaccines in small amounts and the ActHib diluent expired before the vaccine. The diluent expired 3 days ago, the vaccine expires at the end of next month. Per employee we need to revaccinate which we will do tomorrow.
heart palpitations; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) and TACHYCARDIA (tachycardia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations) and TACHYCARDIA (tachycardia). At the time of the report, PALPITATIONS (heart palpitations) and TACHYCARDIA (tachycardia) had not resolved.  No concomitant medications reported. It was reported that the patient was experiencing heart palpitations and tachycardia intermittently about 3-4 times a day, sometimes even when sitting. Patient reported monitoring the blood pressure with EKG machine (results not provided). Patient has no family history of myocarditis or pericarditis.  No treatment medication reported.
This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. On 08-OCT-2013, the patient was inadvertently vaccinated with a intramuscularly 0.5 ml dose of PNEUMOVAX23 (route and dose not reported) (Lot # 671680/1489AA) that had expired on 12-MAY-2013. No adverse effects reported. This is one of five reports concerning the same source. Additional information has been requested.
pt recvd vax 6APR95 445PM pt c/o sore lt arm, swelling, redness, tenderness w/pain on movement noted this AM by mom (area 40cm); mom reports progressively worse until present;
the patient had his 15-month immunizations yesterday. Today he was at home being held by the grandmother when he suddenly began to have tonic-clonic contractions of the upper and lower extremities.  He was unresponsive with eyes rolled up and had some drooling.  The episode lasted approximately 5 minutes.  EMS was called but the parents decided not to wait and instead brought the patient to the ER by car.  Upon arrival the patient became sleepy and is currently awake with decreased activity level. He has not had any vomiting o diarrhea..  No fever at home.  No cold runny nose or cough.  There are no sick contacts at home.  He has no past history of febrile seizures.  There is no family history of febrile seizures.
Pt noticed the rash over her trunk and extremities 1-2 days after the COVID vaccine. She has been seen at the clinic on 1/5 and 1/6/2020. Denied itching, so no treatment was render. Pt applied skin moisturizure to her dry flaky skin after shower and feeling better the next day.
Approximately 10 minutes after receiving the vaccine after using the restroom, the patient reported feeling light headed and clammy. She was laid down and her legs were elevated. She recovered within 10 minutes. She did not lose consciousness.
low to high fever. night sweats. uncontrollable chills. body aches. headache. similar symptoms as the virus
FAINTED; WEAKNESS; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's past medical history included lightheadedness from injections. The patient had no history of any reaction to vaccines before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: GL12A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient was fainted after receiving the vaccine and treated with emergency medical services. On the same day, the patient felt dizzy and experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, and weakness on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW5169) via an unspecified route of administration in the left arm on 02May2021 at 10:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and attention deficit hyperactivity disorder (Adhd). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL) 300 mg and methylphenidate hydrochloride (RITALINE) 20 mg; both from unknown date and for unspecified indication. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 11Apr2021 at 10:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 00:00, after second day of vaccination, the patient had fever (100). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of event fever and included treatment with unspecified over the counter (OTC) fever reducer. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
pain and swelling at injection site has moderated but still present, chills and shivering for about 24 hours after accompanied by muscle ache and general lethargy for about 48 hours.
The patient had extreme joint pain for 2 days following his injection. He stated that it was difficult to stand or walk and he had difficulty opening and closing his hand. He also had an injection site reaction of redness, swelling, and inflammation.
Information has been received from a physician concerning a teenager female who on an unspecified date was vaccinated with GARDASIL (therapy dose, route and site unknown). Subsequently the patient experienced seizure. The patient sought unspecified medical attention. On an unknown date, the patient recovered from seizure. Upon internal review, seizure was considered to be an other important medical event. This is one of several reports from the same source. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, and hospital name (if applicable). Additional information has been requested.
Patient presented to the pharmacy today 2/7/19 with an rx for VALTREX and a rash on neck and face. He informed me that he had received his first dose of SHINGRIX on 2/2/19 and started developing symptoms on the morning of 2/3/19. During a visit with his doctor today, he was diagnosed with shingles and told it was on his neck, jaw, face, top and back of head, and possibly his eye.
Hives for 6 weeks, anaphylaxis reaction 3 weeks after shot, joint pain, facial swelling. I have taken steroids for the past 3 weeks and the hives have shown back up after completion of steroids.
Received shot pn January 5, 2021. After a few days with intermittent headaches, I awoke on January 9, 2021 with severe dizziness. I could not ambulate without looking down at the ground. This grew worse over the next few days. I was seen by a Neurologist on January 12, 2021 who based on my neurological exam ordered me an MRI of the brain with gadolinium. Dizziness persisted and I could not work for three days that week . After a two week period,  it became more intermittent in nature.
Severe headache/migraine ongoing; dizziness for several days; nausea off and on (ongoing); warming sensation throughout body for several days; rash at injection site after a week; jaw and muscular pain (ongoing).
3 PM received Typhoid Vi. 1 hr. later c/o palpitations. B/P 150/92, P - 100. Generally not feeling right. Sent to ER.
From patient report: "1am thurs fever 102.8, chills, pain all over lasted until about noon on fri.  I treated with Tylenol and Benadryl.  But the vomiting that I had on Thurs, I could not keep Tylenol down. I felt so bad and had pain from my hair on my head to my feet, I did not realize my face was red and rash that spread from my injection site up my neck and to my face/lips. My mother video called me Thurs around 9am to check on me and asked what was going on with my face. So I took more Benadryl.  The swelling and rash lasted about 4 days. I missed two days of work".
Information has been received from a registered nurse concerning an about 17 weeks old male patient who on 08-MAR-2010 was vaccinated oral with the first 2 ml dose of ROTATEQ (lot# 664685/1180Y). On 20-APR-2010, the patient was vaccinated oral with the second 2 ml dose of ROTATEQ (lot # 664685/1180Y). Concomitant therapy included PENTACEL and PREVNAR which were administered on 08-MAR-2010 and 20-APR-2010, and hepatitis B virus vaccine (unspecified) (manufactured by GlaxoSmithKline) which was administered on 08-MAR-2010. Subsequently the patient developed intussusception. On 21-APR-2010 the patient went to the hospital and stayed overnight. The patient was given a barium reduction while at the hospital. At the time of this report, the patient was recovering. Additional information has been requested.
Migraine; Vomiting; Diarrhea; Chills; Headache; Brain fog; Fever; Joints ached.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179), via an unspecified route of administration in the left arm on 05May2021 at 09:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis, migraine, aneurysms, anxiety/depression and colitis. Concomitant medications included adalimumab (HUMIRA), botulinum toxin type a (BOTOX), rizatriptan (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) and lamotrigine (LAMOTRIGIN) all taken for unknown indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 12:30, about 3 hours after the vaccine the patient experienced brain fog. On 05May2021 at 15:30, about five hours after the vaccine, the patient experienced headache. On 05May2021 at 21:30, the patient experienced chills (12 hours after shot). On 05May2021, the patient experienced back and forth fever all night and also reported that all of her joints ached during the night. The following day on 06May2021, the patient experienced migraine, vomiting, diarrhea. The patient reported that she still had achy joints and chills/fever. The patient reported that 48 hours post shot she still had a migraine but the other effects were gone. The events did not result in a doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events brain fog, headache, chills, fever, joints ached, migraine, vomiting and diarrhea. The clinical outcome of the events brain fog, vomiting, headache, chills, fever, joint ache and diarrhea were resolved on 07May2021. The clinical outcome of the event migraine was recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
Achy / Chill started about 8 hours after shot. Vomiting started about 13 hours after shot and lasted through the night. Following day chills, achiness, and low-grade fever.  Symptoms were gone within 48 hours of receiving shot. After 3-5 days, left armpit swelling, fluid like pocket formed. This lasted about 2-3 weeks then disappeared.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: pt was very anxious -Severe, Systemic: Shakiness-Severe, Additional Details: after pt received her shot she shopped in the store and then sat down and was very anxious, dizzy, and was shaking uncontrollably
Female patient 75 years old, 15 minutes after immunization reports feeling chest pain. She reports taking medications daily for high pressure condition. We take her vital signs BP 140/50, pulse 65, saturation 98%. Doctor R. recommends transferring her to a hospital to be evaluated by medical and patient refused transportation. Patient call her Dr. by phone and tells her to go home.
This  67 year old white  male received the Pfizer Covid shot on  2/20/21    and went to the ED on 4/20 /21     and was admitted  on 4/20/21 with the following diagnoses listed below. Thrombocytopenia, unspecified
I had fever of 101 that lasted 3 days or so. Then one night I sweated at night and was drenched. The sore throat made it hard to swallow water and lasted 3-4 days. I never was coughing or anything. I had no appetite that lasted 2 weeks. The exhaustion and weakness lasted 2 weeks. The nausea lasted over a week.
Undiluted Purple Cap Pfizer (0.3mL) was administered to patient -
First induration at vaccination site, then fine papular eruptions over upper arms, chest, back and bilateral breasts.