chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; low fever; upset stomach; body ache; headache; This is a spontaneous report from a non-contactable other HCP (patient) reporting for herself. A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 14:00 as dose 2, single for covid-19 immunisation. The patient has clean medical history. Does not take any medication. No medications taken before. The patient had no known allergies. There were no concomitant medications. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 09Feb2021 as dose 1, single for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. Facility type vaccine was school or student health clinic. The patient was not diagnosed with COVID-19 prior vaccination. It was unknown if the patient was tested for COVID-19 post vaccination. On 03Mar2021 at 03:30, the patient experienced Flu like symptoms, low fever, upset stomach, body ache and headache. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment for adverse events included Antihistamine, painkiller, Sudafed. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information was received on 03 December 2008 from a health care professional. A 22 year old male patient received a right arm subcutaneous injection of YF-VAX (lot number UF427AA) on 26 November 2008 at 1:15 pm. On 28 November 2008 at 10:00 pm the patient developed aches, chills, a fever and irritability. The recovery status was unknown. No further information was provided. Follow-up information received on 22 January 2009 from a health care professional. Per the reporter, the patient required a doctors visit on 05 December 2008 and was treated with Tylenol and Motrin as needed. At the time of this report, the patient had fully recovered; however a recovery date was not provided. No further information is expected. List of Documents by Sender: None.
Had some bruising; warm to the touch; intense itching; it was swell; Very red; very tender; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell) and VACCINATION SITE ERYTHEMA (Very red) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VALSARTAN and ATORVASTATIN for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE PAIN (very tender). At the time of the report, VACCINATION SITE BRUISING (Had some bruising), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (intense itching), VACCINATION SITE SWELLING (it was swell), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE PAIN (very tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl and ibuprofen.
systematic immune shock; red bump on chest, legs, arms, looks like chicken pox; hard for him to walk; Itchy; not hungry; nauseous; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of IMMUNE SYSTEM DISORDER (systematic immune shock) and RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30), CHLORTHALIDONE, POTASSIUM CHLORIDE, AMLODIPINE, CLOPIDOGREL, ATORVASTATIN and LOSARTAN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-APR-2021, the patient's wife reported that on an unknown date after the first dose of  mRNA-1273, the patient experienced systematic immune shock, red bump on his chest, legs, arms, and which looked like chicken pox. The patient experienced nauseas, was itchy, not hungry, and hard to walk. The patient was taken to urgent care where he was prescribed antibiotics and advised to take go to hospital. The patient made an appointment with primary care physician where patient was seen. The patient was prescribed a cream and Zyrtec.  The patient experienced IMMUNE SYSTEM DISORDER (systematic immune shock) (seriousness criterion medically significant), RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox) (seriousness criterion medically significant), GAIT DISTURBANCE (hard for him to walk), PRURITUS (Itchy), DECREASED APPETITE (not hungry) and NAUSEA (nauseous). At the time of the report, IMMUNE SYSTEM DISORDER (systematic immune shock), RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox), GAIT DISTURBANCE (hard for him to walk), PRURITUS (Itchy), DECREASED APPETITE (not hungry) and NAUSEA (nauseous) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Nausea is consistent to the known safety profile of mRNA-1273.
my whole arm hurt from injection, tired and didn't eat a lot, a slept . and ended up still get shingles on 01/22/2021
Headache, Myalgia, Arthralgia, sneezing, chills, stuffy nose, eyes watering Narrative:
1 day after VARIVAX immunization had localized rxn around injection site about 2 cm wheal raised, eryth area.
"Documented arm swellings with pain and redness lasting more than 3 days. Untreated." This is the 2nd of two such identical documented reports from this source-no other information was provided.
The day after my second injection I began having extreme mucus in my nose and into my lungs.  Today is 11-3-21 and I'm still having the issue.  I have been working with Kaiser, prescribed antibiotics, inhalers, steroids, nasal spray, seen by a pulmonary specialist, allergist, blood panels done and all tests are coming back normal.  Still have a horrible cough with congestion.  Extreme amounts of mucus that I chock on it.
Pt received a double dose in the left arm, she states arm is red and swollen but no other symptoms/side effects.
Temperature Excursion; Initial report received on 24-Aug-2023.  A certified medical assistant reported that a 49-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.   No relevant medical history was reported.  No relevant concomitant medications were reported.    On 17-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, route, site, and NDC # not reported). On 21-Aug-2023, the patient received the second dose of HEPLISAV-B (Lot # 941428, expiration date: 30-Apr-2025 and NDC # 43528-003-01; route not reported) in the left arm.   On 21-Aug-2023, the patient received HEPLISAV-B after a temperature excursion occurred. No adverse effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pt recvd 1 dose of Engerix-B & p/3 days exp swollen & numb lt side of face, neck, arm & hand; numbness in lt shoulder & bruising @ site of inject;
5 mo old male received DTP/OPV vax in Utah approx 2 hrs later developed urticaria. Seen at hosp on 28DEC90 at 18h50.
pt recvd vax 16NOV92 & mom states bumps appeared 17NOV92; a flesh tone eruption w/o redness or swelling; no temp elevation or vomiting, fretfulness; 19NOV92 scabs appeared; pt may have scratched; seen on 25NOV92; both thighs w/raised rash;
I had assumed that because I was not as active and getting older that I was getting tired more easily. Although I am more active for my age than some people my age as I live on the third floor, I go up and down the stairs four or five times a day. I am finding myself getting a bit more tired than I used to. I do feel that my migraines are starting to get more frequent as well. I am not sure why my migraines may be coming more frequently I have scheduled an appointment with my doctor. I am experiencing swelling in the fleshy part of my arms right inside of the elbow region.
Very severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Very severe stomach pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Very severe stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Very severe stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was orally vaccinated with improperly stored dose of ROTATEQ (dose, frequency and indication were not reported; lot # L027726 with expiration date: 10-MAY-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given adult dose of Pfizer vaccine instead of pediatric dose.  Patient/family stated she was 12 years old but when verifying age in system it appeared she was only 11.
1/6/21 Chills, body aches, fever101, headache and  nausea that last about 48hours
Patient felt very lighthead, found herself stumbling, was very nausea, passed out, 911 was called on 10/24/07 at 1200 pm ambulance came to get her BP 140/80, P 48 - took to hospital - continuously vomiting - did pregnancy test, brain scan, lung X-ray, gave IV Phenergan 2 shots on hips, sent home 3 meds later that night - was out of work for 3 days not including the weekend.
Patient was in office for routine visit and immunizations and medical assistant gave expired vaccine (dated 5/4/19) to patient.
Sore arm; Patient received first dose on 12-Mar-2021, second dose on 16-Aug-2021 and booster dose on 20-Dec-2021; This case was received via another Manufacturer (Reference number: 22K-163-4417969-00) on 02-Jun-2022 and was forwarded to Moderna on 02-Jun-2022.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 12-Mar-2021, second dose on 16-Aug-2021 and booster dose on 20-Dec-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis). Concomitant products included FOLIC ACID and METHOTREXATE for an unknown indication.   On 28-Mar-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 12-Mar-2021, second dose on 16-Aug-2021 and booster dose on 20-Dec-2021). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 12-Mar-2021, second dose on 16-Aug-2021 and booster dose on 20-Dec-2021) outcome was unknown.            No treatment drugs were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality of event sore arm with Humira was reported as reasonable possibility/probable.
Patient reports severe "brain fog."  A conversation ore than 2 minutes and he forgets what he is talking about.  Also reports body aches, arm pain, headache x2 days, fatigue but no fever.
This spontaneous report as received from a physician via company representative refers to a 12 year old patient of unknown gender. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot# and route of administration was not reported). No concomitant medication was reported. The physician stated that unspecified person watched television show which reported that on an unknown date the patient died after receiving GARDASIL. Causality assessment was not provided. Additional information has been requested.
inadvertently administered a dose of VARIVAX and a dose of PROQUAD at the same time in opposite legs; No adverse effects were reported; Information has been received from a medical assistant referring to a currently 1 years old unknown gender patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #: R030605, expiration date: 23-OCT-2020, dose and frequency were not reported) and a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R030798,Therapy type: rHA (recombinant Human albumin), expiration date: 22-APR-2020, dose and frequency not reported) subcutaneously at the same time in opposite legs for prophylaxis (incorrect dose administered). It was not product confusion and no adverse effects were reported.
Gave an adult dose VAQTA to an 18 year old patient. No adverse events reported.
Red welt itchy at site of injection R-arm, Pt called in complaining of itching. Was not able to tell if it was from the bandage or the vaccine itself.
Patient came into office for 1st dose COVID shot, administered. shot expired on 02/02/2023, no treatment required, no adverse outcome
I developed severe chills immediately  after lifting a 40 pound object off of the floor using both arms; severe full body aches; headaches; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6200), via an unspecified route of administration in left arm on 24Feb2021 00:30 at single dose for COVID-19 immunisation. Facility type vaccine was hospital. The patient medical history was not reported. No covid prior vaccination. No known allergies. There were no concomitant medications. The patient previously took first dose bnt162b2 (lot number=EL9269, vaccine location=Left arm]) at the age of 36-year-old on 05Feb2021 11:30 PM for COVID-19 immunization. Patient did not receive other vaccine in four weeks. Patient developed severe chills immediately after lifting a 40 pound object off of the floor using both arms. The room temperature was 73 degrees. Patient put on thermal clothing, wrapped himself in a heated blanket and placed an additional blanket on top, with no relief. Patient debated calling #. Patient was afraid patient would go into shock if patient couldn't get warm. Patient finally found relief by sitting in front of a propane heater, where patient eventually slept. Patient had severe full body aches, chills and headaches for four days which patient treated with ibuprofen and Tylenol. Event onset date was 24Feb2021 23:00. AE resulted in: [Life threatening illness (immediate risk of death from the event)]. No covid tested post vaccination. Therapeutic measures were taken as a result of events (Heat therapy, tylenol, ibuprofen). The outcome of events was reported as recovering.
After reviewing the Consent and Release form, the MMR vaccination was administered first and then the BOOSTRIX. After the BOOSTRIX administration, the patient loss consciousness on the chair for less than 1 minute. Patient stated that she is afraid of needles.
Patient received a third dose of the moderna covid vaccine . A VAR form was provided and staff stated this was the patients second dose and not third dose. After further investigation, it was discovered the dose we provided was the third dose. There were no immediate ADRs.
Have a round red circular mark the size of a silver dollar where injection was given. It is raised and painful and hard to the touch. Started the evening after receiving the injection, still have it 2 days later
Fever, chills, fatigue, nausea, severe joint inflammation from the neck to all joints, down to the feet, elbows and wrists
expired Moderna vaccine administered to patients; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that they received the Moderna vaccine vials with a manufacturing date of 1-Dec-2021 and an expiration date of 1-Apr-2022 Lot-026L21B. They also received Moderna vaccine vials with a manufacturing date of10-Dec-2021 with an expiration date of Jul-2022 Lot-001M21A.   It was reported that expired doses of the Moderna COVID-19 vaccine was administered to 20 patients from lot-026L21B on 06-Apr-2022 to 09-Apr-2022. The reporter stated that the vial was stored in the refrigerator on 05-Apr-2022. Also, mentioned that the vial did not undergo any temperature excursion. Patient did not experienced any adverse reaction at the time of reporting.  Treatment medications were not reported.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672, MOD-2022-538676, MOD-2022-538696, MOD-2022-538692 (Patient Link).
It is raised; It's red going down my arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (It is raised) and ERYTHEMA (It's red going down my arm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (It is raised) and ERYTHEMA (It's red going down my arm). At the time of the report, PERIPHERAL SWELLING (It is raised) and ERYTHEMA (It's red going down my arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported.   Reporter did not allow further contact
5min p/vax pt devel sudden onset of fever, weakness, malaise;chest pain followed & pt was brought to ER where Toradol relieved pain, IV DPH & epi given & IV fluids;eval for MI negative;
Breathing problems, Shortness of Breath, burning feeling with breathing, started 3 days after anthrax vaccination.  Treated with IV Benadryl.  Dx with Late Reaction after Anthrax injection.  Similar problems six months prior after previous anthrax shot; patient required prednisone and rest at home then.
A 2 yr old on the following day of receiving a second dose of Prevnar, developed an injection site rxn with redness and swelling and it appeared puffy.
Client received her first dose Pfizer COVID vaccine on 8.26.21, lot number: FD0809, exp. 10/2021 at 1317.  At 1130, she reported to EMT and EMT/RN that she was ?feeling woozy? and ?feeling sleepy and heavy eye?. At 1335, they transferred her to the gravity chair. They called lead RN and PHN to assist them with client. Lead RN checked her chest and vaccine site on her left arm with no rash or redness observed. At 1335, EMT/RN assessed client who was alert and oriented x 4 and took her vital signs at 1335: blood pressure (BP) 111/70, heart rate (HR) 62, oxygen saturation rate (O2) 97%. At 1342, EMT/RN took client?s vital signs: BP 114/72, HR 69, O2 96% with client stated her symptoms were improving with no other symptoms and drinking water and juice well. She told she ate her last meal at 10:00 AM. At 1355, EMT/RN took her last vital signs: BP 105/66, HR 63, 02 99% and client said that her ?dizziness and sleepiness are gone? with no other new symptoms. At 1355, she told ?I am feeling well to leave? and that she is returning to work for 30 more minutes. EMT/RN and PHN educated client on the adverse s/s to look out for at home and the need to seek EMS with the Pfizer fact sheet given to client. She verbalized understanding. At 1356, client stood up unassisted and walked out from the observation area to return to work as a security guard at the same location as the vaccination site.  At 1405, EMT/RN and PHN saw client sat down on a chair near the exit door of the building reporting she was feeling dizzy upon standing up when she went to the restroom after she left the observation area. She declined any further assessment/treatment and EMS. PHN and her co-workers encouraged client to call her daughter to pick her up to go home. She agreed and called her daughter to come pick her up.  At 1416, client agreed to exit the building in a wheelchair to her daughter?s car by EMT/RN and PHN.