chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He tested positive for COVID-19 on 17Jul2022; He tested positive for COVID-19 on 17Jul2022; he took johnson&johnson covid-19 vaccine on 12Jul2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 12May2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bi-polar disorder" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Abilify, notes: 5mg- Abilify. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2021, outcome "unknown", described as "he took johnson&johnson covid-19 vaccine on 12Jul2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 17Jul2022, outcome "unknown" and all described as "He tested positive for COVID-19 on 17Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Positive. Clinical course: The patient felt fatigued and had a runny nose. The patient believed he received the COVID virus as the result of taking the vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt seen at clinic 2 days after vaccine was given. Site of circular redness to upper left arm approx 3-4 inches above elbow. Site approx 1 inch in diameter and warm to touch. Site very tender to touch. Treatment recommended: ice pack if needed for pain and Advil or Tylenol as needed for pain. Call clinic if sx not improving in 1-2 days or with increased redness or striates up or down arm.
Fever on 8/23/17, but it ended 8/24/17 redness at injection site, warm to the touch.
Patient received TD vaccine, lot TD-183 on 09/24/07 due to a scrape and developed an itchy rash on arms, abdomen, legs, face and scalp couple of days later.  Patient visited ER on 10/03/07 with the rash.  The exact date when the rash started is unknown.  Patient visited dermatologist and was diagnosed with Pityriasis Rubra Pilaris.  Patient is still experiencing a rash a year later.  Follow up on 11/13/08: patient did not go back to the Medical Center and is presumed to be recovered by reporter.
After dose #1 on 1/5/21, patient developed nausea, headache, "stabbing bone pain". Dull pain continued in knees, hips, shoulders, thoracic back pain. Continued bone pain.  Second dose on 2/3/21 with subsequent vomiting, fever, and increased bone pain.
pulmonary embolism; She had huge blood clots in both lungs; She had shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) and THROMBOSIS (She had huge blood clots in both lungs) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polycythemia vera. Concomitant products included RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 2021, the patient experienced DYSPNOEA (She had shortness of breath). On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced THROMBOSIS (She had huge blood clots in both lungs) (seriousness criterion medically significant). The patient was hospitalized on 27-Aug-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse reaction, at an unspecified dose and frequency and Surgery (Surgically removed) for Pulmonary embolism. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) had resolved and THROMBOSIS (She had huge blood clots in both lungs) and DYSPNOEA (She had shortness of breath) outcome was unknown.            On 27Aug2021 the patient was taken to the hospital where she was diagnosed with pulmonary embolism which had to be treated with surgery. After discharge and treatment, future follow ups did not reveal the presence of other embolisms. Currently there are no side effects or symptoms ongoing.  Company comment: This case concerns a 93 year-old, female subject with a history of polycythemia vera, who experienced the unexpected events of pulmonary embolism, thrombosis and dyspnoea. The event occurred approximately 200 days after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable since no data of the first dose was given. The benefit-risk relationship of the vaccine is not affected by this report; Sender's Comments: This case concerns a 93 year-old, female subject with a history of polycythemia vera, who experienced the unexpected events of pulmonary embolism, thrombosis and dyspnoea. The event occurred approximately 200 days after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable since no data of the first dose was given. The benefit-risk relationship of the vaccine is not affected by this report
Very intense seizures unlike those that she has normally. They lasted for about 2 minutes at a time and continued on and off all night.
After MA left room after giving vaccine pt. fainted. Unwitnessed. Parent called office to notify of occurrance. Pt. at that time was at home. Per Mom pt. C/O pain in hip. Full ROM per Mom, but pt. would not left her look at it. Spoke with Mom the next day, no further issues or concerns.
Like mild flu symptoms after 2nd shot; Achiness after 2nd shot; Sore left arm after 2nd shot; Low fever 99F after 2nd shot; Chills after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Like mild flu symptoms after 2nd shot), PAIN (Achiness after 2nd shot), PAIN IN EXTREMITY (Sore left arm after 2nd shot), PYREXIA (Low fever 99F after 2nd shot) and CHILLS (Chills after 2nd shot) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Like mild flu symptoms after 2nd shot), PAIN (Achiness after 2nd shot), PAIN IN EXTREMITY (Sore left arm after 2nd shot), PYREXIA (Low fever 99F after 2nd shot) and CHILLS (Chills after 2nd shot). On 29-Jan-2021, INFLUENZA LIKE ILLNESS (Like mild flu symptoms after 2nd shot), PAIN (Achiness after 2nd shot), PAIN IN EXTREMITY (Sore left arm after 2nd shot), PYREXIA (Low fever 99F after 2nd shot) and CHILLS (Chills after 2nd shot) had resolved.            Concomitant product use was not provided by the reporter.  Treatment medication was not provided by the reporter.  Patient's symptoms was lasted for 3 days.   This case was linked to MOD-2021-410964, MOD-2021-410984 (Patient Link).
Information has been received from a medical assistant, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of VARIVAX lot # M006731 expiration date 09-FEB-2018; lot # M012990 expiration date 14-MAR-2018 and lot # M034586 expiration date 27-JUL-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. It was reported, that the vaccines had a temperature excursion of 9.0 Fahrenheit (F) with a time frame of 70 minutes, also, it was reported that no previously excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted. Sender's Comments: US-009507513-1701USA013127: US-009507513-1701USA008029.
2 days of flu like symptoms- mild to moderate; chills, malaise, diffuse aches and pains.
Common side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Common side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Common side effects). At the time of the report, VACCINATION COMPLICATION (Common side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Feverish but dissipated about 24 hours later. Soreness around the injection area still feels sore 3 days later.
Patient expressed severe pain immediately following the flu shot and is experiencing persisting pain. The pain has caused a lot of pain and wakes her up in the middle of the night. She is not able to have full use of her arm and has not been able to exercise.
COVID-19 vaccine breakthrough case. Dose 1 Pfizer 3/22/2021 EN6200. Dose 2 Pfizer 4/13/2021 ER8733.
Temp 104.2 F, cough, diaphoretic, headache, body aches, chills Patient took Tylenol at home.  No temp by the time he reaches ER.    Patient given ibuprofen in ER.
Patient received Dtap vaccine on March 21, 2012 Mom called concerned that (R) thigh was swollen hot & red - came to office (R) thigh swollen hot red. Measured 12 cm x 14 cm area.
Patient was given vaccine a few seconds after the vaccine was given patient told mom she was not feeling well, per mom patient passed out in her arm and mom laid her down on the floor and yelled to have a staff member help her.
My legs hurt; Headaches; arm still hurts/How long does this Muscle pain less ahead; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm still hurts/How long does this Muscle pain less ahead), PAIN IN EXTREMITY (My legs hurt) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (arm still hurts/How long does this Muscle pain less ahead). On an unknown date, the patient experienced PAIN IN EXTREMITY (My legs hurt) and HEADACHE (Headaches). At the time of the report, PAIN IN EXTREMITY (My legs hurt) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a pharmacist concerning an 85 year old female with no known allergies, who on 18-MAR-2008 was vaccinated subcutaneously with "1 vial " of ZOSTAVAX. There was no concomitant medication. In April 2008 and again in May or June 2008, the patient developed shingles after receiving ZOSTAVAX. The patient saw the physician. No lab diagnostic studies were performed. At the time of reporting, the patient had recovered from the AEs (date not specified by the reporter). There was no product quality complaint. Follow up information was received from the physician concerning a 88 year old female with no medical history, no known allergies who was vaccinated with ZOSTAVAX. There was no concomitant medication. The patient experienced herpes zoster twice since the immunization. On 10-JUL-2008, the patient recovered. There was no illness at the time of vaccination. No laboratory/diagnostic tests were performed. The reporting physician felt that the patient's herpes zoster was serious as an other important medical event. No further information is available.
The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023; No adverse event; Patient had dose administered after 30-day Use By Date or after manufacturer date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, 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 02-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient had dose administered after 30-day Use By Date or after manufacturer date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 30-Jan-2023 (BUD 01-Mar-2023) and was adminitered on 02-Mar-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that bivalent vial of unknown size was administered to 5 patients after 30 days use by date. The vial never underwent any temperature excursions. No adverse reaction was reported by patient at that time.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-714731, US-MODERNATX, INC.-MOD-2023-714608, US-MODERNATX, INC.-MOD-2023-714789, US-MODERNATX, INC.-MOD-2023-714792 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714731:Same reporter US-MODERNATX, INC.-MOD-2023-714608:Same reporter US-MODERNATX, INC.-MOD-2023-714789:Same reporter US-MODERNATX, INC.-MOD-2023-714792:Same reporter
pt recv vax & exp lump @ the inj site, described as thick, knotty & lasting for a couple of month's;
weakness in area spreading to groin area; Sever left hip pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIOTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 68-year-old via an unspecified route of administration in the left arm on 28Feb2021 11:00 as a single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure and asthma. The patient has no known allergies. There were no concomitant medications. The patient did not have Covid prior vaccination. The patient has not received other vaccine in four weeks. On 01Mar2021 08:00 AM, the patient had weakness in area spreading to groin area and severe left hip pain. The adverse events resulted in disability or permanent damage. No treatment was received for the adverse events. The patient has not been tested post vaccination. The outcome of the events was not recovered.  The following information on the batch/lot number has been requested.
chills, dizziness, difficulty breathing, severe weakness, sleepiness, tremors all over the body, trembling, electricity-like motions all over the body, swollen parotid glands, dry mouth.It has been almost 3 weeks since MMR vaccine and I am feeling worse now then when the vaccine was given. I spent the last 2 days in bed feeling very weak and thirsty. I am dizzy and about to pass out. I was not like that before the MMR shot.
I got a wide spread rash on my arms and my legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE, solution for injection), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) (at the age of 58 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced got a wide spread rash on his arms and his legs on 31Mar2021. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Patient became pale, diaphoretic, and experienced a syncopal episode, laid flat and then had simple partial seizure lasting 10 seconds, became incontinent, IV started, A and O x4 , transported to hospital via ambulance
Woke day after vaccination with slightly red right eye. Woke 2nd day with very red right eye. Little watery but no pain.
Season flu vaccination given 10/9/09. Within 10 minutes pt states he began to feel dizzy and nauseated. Started vomiting 45 after shot. Reported back to OCC Health clinic 1 1/2hrs after shot was given. Observed x 2hrs then sent home with family.
The Pt went to  to get their first dose of covid vaccine. They have received moderna for the first dose. When they came to  she has received Pfizer second dose in error. No adverse events were reported by the pt.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency, route of administration, lot# and expiration date were not reported) all of which underwent a supported temperature excursion on an unknown date. No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) for each time were 384, 34 and R; 72, 31 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Lethargy & fever 104 (w/in 6-10 hrs); Seen in ER; PE neg; tx APAP & Advil; no fever from 3rd to 10th day- then devel fever on day 10;
13JUL92 pt recvd 1st dose of vax & immed devel intermittent h/a & was not feeling well; took APAP but  sx persists;
Case was vaccinated and Boosted x1 for Covid as of October 2021, then was hospitalized for Covid in May 2022. Hospitalized at:  Hospital           COVID-19 virus infection Assessment & Plan Presented with nausea/vomiting, headache, mild cough, and found to be hypoxic and tachycardic. He has had both vaccines and a booster, but last was 7 months ago. He tested positive for COVID 11 days ago. He is overweight, diabetic, and has history of hypercoagulability on reduced dose Eliquis which may increase his risk for severe disease. He did complete 5 days of Molnupiravir. CXR negative. Dexamethasone 6mg daily was started given the concern for his symptoms being related to COVID. CRP elevated to 3 this morning.  - Discontinue dexamethasone at discharge  - Return precautions given   * Hypoxia Assessment & Plan Found to be hypoxic in the ED requiring 2L. He had a mild cough with recent COVID infection 11 days ago s/p treatment and resolution of symptoms. Initial concern for DVT/PE given his history of protein C deficiency and reduced dose of Eliquis. CXR, d-dimer, and LE doppler US negative. Clinically improved with IV fluids and oxygen overnight, now off of oxygen. I suspect symptoms are related to his prior COVID vs new viral infection.
This spontaneous report as received from a pharmacist via company representative refers to a 59 year old female patient. On an unknown date, the patient was vaccinated at unspecified pharmacy with a dose of ZOSTAVAX 1 injection (dose, dose number, lot/batch number, exp. date not reported) subcutaneous. On an unspecified date, immediately after vaccination, the patient experienced hard lump that was itchy and painful to scratch at the injection site. There was no treatment given for the events. The patient did not seek medical attention. The outcome of event was reported as recovered/resolved, all symptoms cleared up after 5 days (date unspecified). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
patient tested positive 6 days after the 1st dose; patient tested positive 6 days after the 1st dose; This is a spontaneous report from a Pfizer-sponsored Program, Pfizer. A contactable physician reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive 6 days after the 1st dose. The patient asked about the ingredients of COVID-19 Vaccine. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
pt recvd vax; quarter size swollen welt at inject site immediatly p/ vax; pt given ice pack & DPH po;
Information has been received from a nurse referring to a patient of unknown age and gender. On 30-JUN-2016 the patient was vaccinated with expired M-M-R II (rHA, lot # K008625, expiration date 30-JUN-2016, dose and route were not reported). No adverse symptoms were reported. Additional information has been requested.