chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little bit of pain in the injection site; soreness in the lower part of her leg; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored via Regulatory Authority support. A female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. She took aspirin 36 hours before the vaccine and asked how much the efficacy was. The patient experienced little bit of pain in the injection site and soreness in the lower part of her leg on an unspecified date. The outcome of both the events was unknown.  Follow-up attempts completed. No further information expected.
2 hours after receiving vaccines, patient developed hives, rash, facial swelling & difficulty breathing was taken to ER, treated with BENADRYL & released.
Initial extreme dizziness two days after the injection. Now lightheadedness much of the time, sense of being on a boat.
1st shot: Started period 2 days after shot.  Had hemorrhagic bleeding 24/7 for 28 days straight.  Bleeding was constant and excessive, would not stop.  Was going through 40+ pads a day, having to change every 30 minutes or so to not leak. Very upsetting. Went to dr for bloodwork, had CBC and results returned normal.  Dr encouraged me to have 2nd shot.  Period stopped 2 days after 2nd shot  2nd shot: Had shot on a Wednesday. That Saturday had hive/rash at injection site. Red, warm, itchy, raised. Treated with OTC Benadryl.
Quickly after the vaccines were given (nurse giving shots was still in the room) pt had an episode of pallor. He cried right away and had no trouble taking the RV orally. He was alert, no distress or difficulty breathing, no hives or redness. He was moving extremities but not as vigorous or active as usual. I was called into the room and examined him within minutes after this happened. Exam was normal except he was pale, not cyanotic. No rash, no hives. No swelling of lips or any part of body- did not seem to be irritable or in pain. He was alert but not as vigorous. Good tone, not lethargic, but still. He took a bottle well at that point. Lungs, heart and abd exam all normal. PERLA, neuro exam as above. This lasted less than a total of 10 minutes and he slwoly regained his pink color. We waited for a total of 45 minutes in the office after this happened. Once mom got home he was continuing to look and behave normally  (although not quite normal color per mom until shortly after they got home)
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with 23 of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 16-year-old adolescent patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 27-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number: 1022277) received from quality assurance department on 29-Jul-2017: Quality assurance investigation results were updated and the narrative was amended accordingly. Non significant case correction received on 10-Aug-2017: Narrative and case comment were corrected.
Fluzone/Pneumovax administered Saturday.  Patient in bed Sunday, couldn't get up, achy, 99.0 fever.  Monday afternoon felt fine.
12/17/2020; 1158 am had injection. at 2pm, noticed trunk itching around waist, abdomen, back. No visible rash. mild soreness and redness to injection site on left deltoid.  530/6pm developed SOB, rash is now visible, non raised, very itchy trunk. Took 10 mg Zyrtec. Went to ER nausea, vomiting, moderate to severe abdominal pain, flared angina and chest pain with the shortness of breath.  ER; DR. CONTINUED WITH BENADRYL 50MG  4-6 HOURS, DUE TO ONGOING ITCHING.  FAMOTIDINE 20 MG 2X/DAILY Had flu shot between 09-10/2020
The doctor stated the location of administration was absolutely not in the deltoid/vaccine administered in the top of the shoulder; The caller states she is 9 months pregnant; Lost mobility in the left arm completely for a few days; Unbelievable amount of pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 31-years-old female patient received first dose of BNT162B2, Solution for injection, Batch/Lot Number: EW0180, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 06Aug2021 (at the age of 31-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included pregnancy. She stated that she was 9 months pregnant. History: Besides being pregnant, probably not. There were no concomitant medications. Clinical course:  She received her first dose Pfizer Covid Vaccine three weeks ago. Vaccine administered in the top of the shoulder: The patient stated the first dose Pfizer Covid Vaccine was incorrectly administered. The person who administered the first dose Pfizer Covid Vaccine, administered the first dose Pfizer Covid Vaccine in the top of the shoulder. This caused lose mobility in the left arm completely for a few days and an unbelievable amount of pain ( on unspecified date in Aug2021). The patient went to the urgent care the next morning because she thought this was not a normal reaction and something went wrong. She told the doctor she was just sitting in the (withheld) chair when the first dose Pfizer Covid Vaccine was administered. The doctor stated the location of administration was absolutely not in the deltoid(Left top of shoulder)(on 06Aug2021), the first dose Pfizer Covid Vaccine was administered in-between the bones and likely hit a nerve or bursa area. Could cause bursitis or whatever. Lost mobility in the left arm completely for a few days/unbelievable amount of pain: She stated that she was still in pain three weeks later and did not have full range of motion in the arm. This was annoying because it was avoidable. The patient was 33 Weeks pregnant at the onset of the event. The outcome of lose mobility in the left arm completely for a few days and an unbelievable amount of pain was not recovered. The outcome of other events was unknown.
red rash on her arm that is hot to the touch and itchy; red rash on her arm that is hot to the touch and itchy; red rash on her arm that is hot to the touch and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red rash on her arm that is hot to the touch and itchy), VACCINATION SITE ERYTHEMA (red rash on her arm that is hot to the touch and itchy) and VACCINATION SITE PRURITUS (red rash on her arm that is hot to the touch and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE WARMTH (red rash on her arm that is hot to the touch and itchy), VACCINATION SITE ERYTHEMA (red rash on her arm that is hot to the touch and itchy) and VACCINATION SITE PRURITUS (red rash on her arm that is hot to the touch and itchy). At the time of the report, VACCINATION SITE WARMTH (red rash on her arm that is hot to the touch and itchy), VACCINATION SITE ERYTHEMA (red rash on her arm that is hot to the touch and itchy) and VACCINATION SITE PRURITUS (red rash on her arm that is hot to the touch and itchy) 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   Reporter did not allow further contact
Gardasil vaccine given to a pregnant patient by mistake.  Rhogam was to be given.  Physician saw patient immediately and informed patient and husband.  No adverse reaction.
PT COMPLAINED OF FEELING DIZZY A FEW SECONDS AFTER RECEIVING A Tdap vaccine. WITHIN SECONDS, PT FAINTED AND THEN BECAME UNCONSCIOUS. 911 CALL WAS PLACED, THEN IN ABOUT 2 MINUTES PT REGAINED CONSCIOUSNESS. PARAMEDICS WERE AT THE SCENE LATER BUT PT HAD ALREADY REGAINED CONSCIOUSNESS. PT WAS ASKED TO DRING WATER AND LAY DOWN FOR SOMETIME BEFORE GETTING UP. PT LIED DOWN FOR ABOUT 20 MINUTES WHILE BEING MONITORED. THEN LATER WAS ABLE TO GET UP ON HIS FEET AND LEFT OUR FACILITY WITH HIS SPOUSE.
This spontaneous prospective pregnancy report as received from a nurse refers to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies who was 31 weeks pregnant. On 03-JUL-2014 the patient was vaccinated with a dose of GARDASIL lot # J009788, expiration date: 17-MAR-2016, 0.5 ml/once, intramuscular. Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) (Prenatal Vitamin). The nurse stated the GARDASIL dose was "given by mistake, we knew she was pregnant long before 03-JUL-2014, reported as "today", cause she's 31 weeks". The Last Menstrual Period (LMP) was 28-NOV-2013 and Estimated due date (EDD) was 04-SEP-2014. Initial exposure to GARDASIL was at 31 week(s). The outcome of the event was unknown. No laboratory test was done. Additional information is not expected since reporter refused additional contact.
Child slept unmoving for 24 hours after receiving her 1 mo Hep B.
This spontaneous report as received from an other health professional refers to unknown number of patients of unkonwn age. Medical history and current conditions were not reported. On an unknown date, the unknown number of patients was vaccinated with PROQUAD (Merck), lot number: K007156, expiry date: 12-NOV-2015, 0.5 milliliter, subcutaneous. Concomitant medications were not reported. On an unknown date, the unknown number of patients have received PROQUAD (Merck), that had been stored in the refrigerator at 34-40 degrees Fahrenheit (F) for 59 days. It was unknown by the caller if any company refrigerated vaccines were exposed to temperatures below 36 degrees F and were administered to patients. No adverse effect was reported. No product quality complaint was reported. Additional information has been requested.
I missed two periods after both my first and second shots of the Moderna vaccine.  I received shot 1 February 2021 and my cycle was 85 days (I?m regularly 28) I received shot 2 end of March 2021 and my cycle was 85 days (I?m regularly 28) I received my booster (also Moderna) November 2021 and my cycle was 44 day.
Arm became very hot and sore, headache started around 5 p.m. on the 6th.., woke with fever of 100.9 at 4 a.m. on the 7th, was nauseous, developed diarrhea, and overall muscle pain and tiredness  Used tylenol, drank extra fluids and rested. It is now 3 p.m. on 7th. and the headache is gone, fever down to 99.1, muscle pain is much less, and tiredness is improving.
Patient reported that after receiving vaccine her arm became red and hot. After a couple of days she saw her provider and was diagnosed with cellulitis. She was prescribed cephalexin and is currently taking the medication.
Hives/rash/itching all over body continues til now 3/2022. Itches as bad as shingles
Patient developed a large erythematous rash on the right upper arm in the area of injection site. The patient reported the rash as both painful and hot. The rash resolved after several days (~7days) with NSAIDs and ice. The patient is left with a dark circle in the area where the rash occurred and the skin is slightly scaly.
Stiffness leading to pain from neck movement; throbbing head pain; soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness leading to pain from neck movement), INJECTION SITE PAIN (soreness around the injection site) and HEADACHE (throbbing head pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness around the injection site). On 01-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness leading to pain from neck movement) and HEADACHE (throbbing head pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness leading to pain from neck movement), INJECTION SITE PAIN (soreness around the injection site) and HEADACHE (throbbing head pain) outcome was unknown.            No Relevant concomitant medications was reported.  Treatment information included Ibuprofen daily.
Lymphadenopathy - noticed in June to current Swollen Lymph Nodes - noticed in June to current Reactive Lymph Nodes - noticed in June to current Sweats - late summer to current Rash / Nodule Lumps - June to July Headache - 03/05/2021 to 03/10/2021 Fatigue - 03/05/2021 to current Eye - itch/burn/pain - March and April Swollen body parts / fatty tumors
Information has been received from a physicianand a health professional concerning a 170 pound, 64 inch, 24 year old caucasian female pharmacy technician with no pre-existing allergies, birth defects, medical conditions, or illness at time of vaccination who was vaccinated with a dose of GARDASIL. The physician reported that the patient out in hives after she got the dose GARDASIL (lot #654272/0073X). IM to the deltoid on 01-APR-2008, at 5:00PM. It was reported that patient received her injection at a pharmacy and a family member who was a nurse administered the vaccination. The physician and health professional reported that the patient brkoe out in hives, itching, whelps, and a rash on 02-APR-2008 after she got the dose of Gardisil. The patient sought medical attnetion via a doctor visit. A culture of the pus from the welps was taken and was positive for a staph infection. The patient reportedly recovered on 06-APR-2008. No treatment information was provided. A standard lot check investigation was performed. All in-process quality checks for thw lot number in question were satisfactory. Inaddition, an expanded lot check investigation was performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No additional information is expected. Additional information has been requested.
I went to get my shot at 3pm. After being vaccinated I sat about 30 mins in waiting room and nothing happened. I then went home and when my husband and I were preparing to eat supper, I noticed I didn't have an appetite which was around 4:30 pm, We had our normal quiet evening at home and around 9 or 10pm I was watching tv. Normally If I don't fall asleep,  I watch Law and Order because it's quiet and I can fall asleep. I watched tv all night until 7 in the am came and I was still awake I called in and told my job I would be there around 5 pm but would take the day portion of my shift off.  Around 10 am I had a sharp headache with uncomfortable body aches and I was tired. I wasn't able to engage at all. My husband checked on me and I told him to turn the light out and not to touch me. I was  in and out of sleep. I do recall having a glass of water around 3am. On the 3rd day I got up to get a glass of water and sat at the dining room table and I felt the symptoms were over.  I heard the windows rattling similar to when we had a blizzard I also kept hearing a song playing and wondered why it was playing, It reminded me of a soft rock song from the 60's, I then realized I don't have a radio and the music was just playing in my head. I wasn't able to move for 3 days. I told my husband he should have called an ambulance and the next time something like this happens to call  . I had back pain by the weekend and it caused me to hunch over. I went to the chiropractor at the end of the week they took an x-ray. I was advised my back was slight unaligned and this could be a possible result of previous back issues. Thursday night I didn't go to work which was not normal and my job was worried .I had my cellphone in my bed but I couldn't answer I was so out of it. My son who is 35 was vaccinated the day after me. He came downstairs to ask if we were playing jazz music. he heard the music playing as well but different from the type of music I was playing. My husband had zero symptoms, he was vaccinated at the same time as me.
Red rash, VERY itchy area around injection site.  Did I mention VERY itchy.  No medications, ointments, or creams used on itchy area.  No oral medications taken for itch or rash.  Currently on day three of itchy and it seems a little better.  Waiting for a few days for condition to clear.
started with redness and itching at site of injection and around the area on Saturday 1/23/21.  It is still itching today, not as red.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Severe, Systemic: Weakness-Severe
pt recvd vax & w/in 24 hrs pt devel dizziness & was "sick to her stomach off and on";
49 year old patient gets first dose Janssen #1816022. Patient refers pain in the puncture area left limb. Dizziness, cloudy vision and chills. Patient is considered to be oriented, pale, sweaty and cold to the touch.
This is a spontaneous report from a contactable physician via a sales representative. A patient of unknown age, gender and ethnicity received TRUMENBA at 0.5 ml single dose on unspecified date. Concomitant medications and medical history were not reported. About 5 hours after the injection was given, the patient had site reactions, warm, red, and a little hurt, painful and there was some itching too, so the patient called back to the office and it was suggested to BENADRYL because of the itching and redness. The patient was told to call back if symptoms persisted, but patient did not call back so the physician assumed everything was fine. The physician visited the patient the following week for something unrelated and everything was fine. Causality was not available. Follow-up (10JUL2015): Follow-up attempts completed. No further information expected.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age of patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ024AA via intramuscular route in the right arm on 10-Sep-2018 and on 25 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered. It was an actual medication error due to extra dose administered. It was reported that a patient may have received two doses of FLUZONE HD within 2 weeks on 10-Sep-2018 and on 25 Sep 2018. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
vaccine administered more than 6 hours; 2nd dose administered more than 12 hours after puncture; Adverse events related to the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered more than 6 hours), EXPIRED PRODUCT ADMINISTERED (2nd dose administered more than 12 hours after puncture) and VACCINATION COMPLICATION (Adverse events related to the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered more than 6 hours), EXPIRED PRODUCT ADMINISTERED (2nd dose administered more than 12 hours after puncture) and VACCINATION COMPLICATION (Adverse events related to the 2nd dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered more than 6 hours) had resolved and EXPIRED PRODUCT ADMINISTERED (2nd dose administered more than 12 hours after puncture) and VACCINATION COMPLICATION (Adverse events related to the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment information not provided. Company comment: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 031A21A)  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14-APR-2021 .Events updated On 15-Jul-2021: follow up received and contain non significant information.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 031A21A)  with no associated AEs.