chrisvoncsefalvay/vaers-outcomes huggingface dataset:
back pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sponsored Program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced back pain on an unspecified date with outcome of unknown. The patient received vaccine on 31Mar2021 and wanted to know if he could take Mortrin or Tyleonol for back pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Urine bleeding "like a slightly pink in the urine"; sore arm; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Urine bleeding "like a slightly pink in the urine"), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01320MA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported ).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HAEMATURIA (Urine bleeding "like a slightly pink in the urine"), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (Diarrhea). On 23-Feb-2021, HAEMATURIA (Urine bleeding "like a slightly pink in the urine") and DIARRHOEA (Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to a 54 year old male patient. On 10-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409, expiry date 04-MAR-2016, dose 0.5 ml, intramuscular). Concomitant medications were not reported. On 11-NOV-2014, the patient experienced rash and cellulitis at the injection site. Patient sought medical attention-he was assessed by a physician and no treatment was prescribed. No laboratory studies were performed. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. Product quality complaint was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Patient received 3 doses of H1N1. Patient and parent did not communicate patient already had 2 prior doses.
Redness, swelling, tenderness at injection site.  Redness is approximately 8 cm in diameter with mild swelling.  Able to ambulate without difficulty.  No NSAIDS administered by parent.  Evaluated in clinic on 12/3/10 for the above symptoms.  She also has had 5 episodes of emesis since 12/1/2010.
A few minutes after receiving the vaccination, patient became lightheaded, pupils became dilated.  She was sweating, had vision problems, and on the verge of fainting.  Her pulse and breathing were ok.  Paramedics were called.  When they arrived on the scene (about 5 minutes later) patient was returning to normal.  The paramedics checked her out, said her blood pressure was low they escorted patient and her mother to their vehicle.
The next day after the vaccine, I had diarrhea for one week until 4/30/2022. The first day was the worse, the as time went by it got better.
Low-grade fever, chills, muscle aches, headache, fatigue, joint pain. It lasted 2 days
Irregular heartbeats, gets worse and more noticeable every week. Heart murmur was heard by doctor, referred to Cardiologist.
brief head drops w/eye rolling;cyanotic episodes, BP fluctuations;apneic episodes w/tonic stiffening;sz disorder, intractable;s/p several hospitalizations;
Felt very tired and some dizziness, weakness, no appetite, body aches, and just felt lousy all day the next day.  Feel better now on the second day but still not 100%.
Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
can't sleep because of it; real persistent muscle pain since the shot; This is a spontaneous report received from a contactable reporter (Nurse).  A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hypothyroid", start date: 2014 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu shot, for immunization, reaction: "muscle pain". The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "not recovered", described as "real persistent muscle pain since the shot"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep because of it". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia. Additional information: Patient had his first shot 2 weeks ago and has had real persistent muscle pain since the shot. Reporter said she knows that most of the time this would go away pretty quick, but his hasn't let up and he is supposed to go back for his second shot next week, and he was not sure if he should. She said she advised him to hold off for now and she would look into getting more information for him. Reporter said the patient didn't have his vaccine card with him, and she is not sure where he had it done, said they were not provided with the NDC/LOT/EXP for his vaccine dose. Reported said the patient said he has been taking Ibuprofen and Aleve (UPC/LOT/EXP for Aleve and Ibuprofen unknown). She said today he told her he has been taking 1-2 Aleve every two hours, which she advised him to stop that. Patient has not had any other recent vaccinations or started any new medications. Reporter said patient did mention sometimes this happens when he gets the flu shot (NDC/LOT/EXP Unknown). Reporter said patient doesn't take the flu shot any more, she has tried to get him to take it, but he said he won't because of the side effects. Reporter said she asked the patient if those side effects were as bad as this, and he said the ones from the flu one goes away in a few days. She said their facility has never given the flu shot to him, so they have no record of it. Reporter said they drew labs today for blood count, but the last time they did was his thyroid on 15Mar2021, for which his TSH was slightly over but not bad, and that was the only lab done. Reporter assessed the patient's persistent muscle pain as not serious. She said patient said he can't sleep because of it. Reporter said the patient really just has pain; no fever, chills, or trouble breathing, nausea, or vomiting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
At 5:00PM on 2/3/22,  patient's dad  informed the pharmacy staff that patient had fainted and lost consciousness. Patient woke up within a few seconds (dad estimated 10 seconds) and was speaking to us and conscious. She was unaware that she had fainted. Water was provided and patient states that she was warm and parents took off her sweater to cool her off. Tried to call emergency services for patient but when patient woke up, parents declined. Parents states that she has no allergies or reactions to any vaccinations or medications in the past. They also stated that she only takes a daily multivitamin gummy and has no chronic health conditions of any kind. Patient, herself, did state that she was really stressed for the vaccination. Parents  states that she might have been really stressed and anxious for the vaccination and might have had a panic attack after the vaccination. Patient has no visible physical injuries.  At 6:27PM, parents and patient states they were okay now, and it was just a panic attack and that she was feeling a lot better now and okay to do a bit of shopping before leaving for home.
Bloody diarrhea with mucus, 101.2 temp for three days, positive hemocult.
PATIENT HAD IMMEDIATE SWELLING AT INJECTION SITE OF ABOUT 1.5 CM. NO BREATHING ISSUES, RASH, OR SYNCOPE WAS OBSERVED. PATIENT SAT FOR 15 MINUTES. ADMINISTERED IBUPROFEN 600 MG AND LORATADINE 10 MG. ADVISED PATIENT TO CHECK WITH ER IF SYMPTOMS OF ALLERGIC REACTION DEVELOP. TWO HOURS LATER, CALLED PATIENT TO FOLLOW UP. NO ADDITIONAL REACTIONS WERE NOTED.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other medication in 2 weeks. The patient was treated with anti-viral details for COVID 19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 1 year old patient, who in approx 1998 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Five days post-vaccination, the pt experienced a grand mal seizure and was afebrile. On 04/10/2002 it was reported that the patient has been fine since and is now 4 years old. Upon internal review, the pt's grand mal seizure was determined to be an other important medical event. Unspecified medical attention was sought. Additional info has been requested.
Patient states had racing heart and was unable to do anything. Concerned that she was having reaction to vaccine and went to Emergency Department for Treatment. Given Benadryl and discharged.
got sick every time; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 04-Dec-2020.  This case involves a female patient of unknown age who got sick every time (illness), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient got sick every time (illness) following the administration of INFLUENZA VACCINE.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
"Covid arm"  3/4 inch diameter around injection site is pale, hard and sore. From the perimeter of the pale are out to 2 inch diameter, raised, red rash that itches and is hard and sore.
Resident passed away on 10/8/23 at facility. Resident transfer on 10/3/23 to facility for LTC.
Information has been received from a consumer concerning an approximately 5 - 12 year old child who in approximately 1996 - 2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced a mild case of chicken pox. Unspecified medical attention was sought. The patient subsequently recovered. There was no product quality complaint involved. Additional information has been requested.
Arm was just a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   In MAY-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was just a little sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that she/he had shingles for 3 months very painful. Patient did not have the shot. Patient just got the shingles shot 3 weeks ago before reporting, arm was just a little sore and no problem at all. Patient stated please get the shingles shot it was well worth it. The follow-up could not be possible as no contact details were available.
Breakthrough  case admission after 3 vaccines Pfizer 3/1/21 Lot# En6207;  Pfizer 4/1/21 Lot# ER8737;  Moderna 11/22/21 Lot# 012H21B
Arrived with cough, SOB, fevers x3 days after COVID exposure. Positive in ER, COVID pna w/ respiratory failure. Received O2, steroids, IV zithromax ans rocephin, vit-c, zinc, remdesivir. Improved and DC home with O2.
4.5 X 5 cm round area of erythema with warmth and a central area of bruising. Very itchy.
Skin sensitivity, itchy face in cheeks and mandible folds, flushing in face. Patient took diphenhydramine 25 mg liquid at 10:50 and one more capsule 20 minutes later.
Information has been received from a Bachelor of Science in Nursing (B.S.N.), concerning a 16 months old male child. The patient had no pertinent medical history and no known drug allergies. On 20-AUG-2012, the patient was vaccinated subcutaneously with a dose of (Merck) VARIVAX (lot #: 0045AE; Expiration date: 20-DEC-2013). There were no concomitant medications reported. On 29-AUG-2012, the patient developed "three spots on him". No treatment was given for the event. No lab diagnostic studies were performed. The patient sought medical attention through phone call to office. At the time of the report, the patient's outcome for the three spots on him was not recovered/not resolved. Additional information has been requested.
I did not have any effects from the vaccine besides a sore arm.  I recently had my annual exam and the blood tests show I now have thrombocyctosis.
Developed PTSD or Secondary Trauma syndrome within 2 weeks of second shot. Had to go on medical leave as I was not sleeping, crying, developed intrusive thoughts, nightmares, anxiety. Have been seeing therapist and psychiatrist, placed on Prozac instead of Cymbalta. Doing CBT and exposure therapy, sleep journaling. I remain off work currently
pt recv vax 6MAY96 & 20SEP97 pt devel chickenpox w/a rash, papule, vesicle & five lesions;pt recovered;
On 3/2/21 had arm discomfort into next day, felt tired, on 3/11/21 started with body rash on back, stomach, groin area, base of skull, and chest. Dr. said to take Zyrtec or Benadryl, neither had any effect. I was then prescribed Methyl PREDNISolone tablets 4 mg.
Immediately, upon standing after Injections, I felt faint + nauseous; sat down + immediately felt searing, burning pain across neck, down to Lower Lumber for about 10 min. After 20 min. Felt well enough to go home. However, at 7 PM, I felt like a truck hit me! Extremely dizzy, nauseous, pain all over body, including my chest + High Blood Pressure 150/105 90 BPM - I proceeded to have uncontrollable shakes + Felt Freezing cold. Lasted 5 hrs. My husband, called my PCP to see what to do + kept in touch with him. My husband gave me 1 Advil + later 1 x strength Tylenol + slowly my Blood Pressure returned to 114/60 87 BPM at 11:50 PM. Extremely Terrifying Experience!
Fatgue, dizziness, cough, general malaise, aches in legs, pressure behind eyes, hypersensitive skin lasting for 3 days.
Roughly around 10 pm on 10/04/2021, patient experienced severe chills and shivering which caused her to not nurse her baby.  She reports she had a sustained fever of 102.1 degrees F from 2 am 4 am.  She self-administered Tylenol 650 mg at 4 am which alleviated the fever and aches.
In September 1999, pt recvd first dose of Lymerix. Within 24 hrs post vax, he experienced soreness at the injection site. In the Spring of 2000, he began experiencing "burning" in his knee joints. He was scheduled to be seen by a healthcare professional on 6/27/01. He had not yet recvd any medical tx for the knee discomfort. As of 6/27/01, the burning sensation in the knee joints was ongoing. The outcome of the soreness at the injection site was not specified. The adverse event of "burning in the knee joints" does not meet ICH serious criteria but is being submitted as an expedited report by special FDA request. The follow-up info received on 10/11/2001 states that the physician did not confirm the injection site soreness. In May 2000, he was seen by the vaccine provider, who noted swollen and warm knee joints on physical examination. It was not specified if joint fluid was obtained. Erythrocyte sedimentation rate, measured on an unspecified date, was 1mm/hr. Antinuclear antibody titer was measured on an unspecified date; results were not available as of 10/11/2001. An unspecified Lyme test date performed was negative. The vaccie provider considered the burning pain in the knee joints to be mild in intensity and possibly related to LYMErix administration. The joint symptoms resolved in October 2001.
Left arm pain after receiving J&J vaccine. Pain started immediately after receiving the vaccine and has persisted for 3 weeks now. Pain: muscle soreness in the shoulder. When not moving, pain is level 1. When moving arm, pain level is 5. It's not sharp pain but persistent and annoying.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. It is unknown whether patient had any allergies. It was unknown if patient had acute illness at the time of vaccination as well as unknown for chronic health conditions. The patient's past medical history included COVID-19. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:30 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/ Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/ Expired vaccine administered) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM). No concomitant product reported by reporter. It was unknown if patient experienced similar adverse event in the past. Vaccine did not undergone any temperature excursion issue. Vaccine was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM. No treatment medication reported by reporter.
At approximately 1320 hours, A patient housed in a facility was scheduled by Admin staff for a 3rd dose Phizer.  This individual was registered in the system and was the first individual patient that was visited for the vaccination. After the nurses arrived back to the dining area to identify other patients to give vaccinations too, the patients CDC card was located.  Note that the CDC cards were provided to staff in a Tupperware container, and all of the cards had to be checked to find the individual patients that we needed to provide.  It was discovered that the first patient vaccinated had already received his 3rd dose Pfizer on October 15, 2021.  I advised the staff that we will not provide any other doses unless we can verify the proper dose in database.  The appropriate lead was advised of the situation and agreed with our method going forward.  The clinical lead conducted a VAERS report on the incident and notified her chain of command.