chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received MMR, Friday 06/03/2005.  Noticed bright red rash, swelling, warmth to site, Saturday 06/04/2005 in PM.  Sunday 06/05/2005 swelling decreased, no itching, pinkish- red at site.  Monday 06/06 site warm, slightly irritable with slight itching, swelling much more decreased, per report of patient.  Today, tears, 06/07/2005 seen in clinic - site pink, warm, area measured 2in x 2 inches.  Patient actively rubbing site.  Ice pack placed.  Blood pressure 120/70, rate 26, pulse 70 at 2:30PM.  Pink color and warm dissipated.  Advised to go to doctor or ER, should symptoms worsen.
This is a vaccine administration error, not an adverse event. Moderna vaccine was given to the wrong age patient.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;PK/10" (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had nine temperature excursions: 64 hours, 152 hours, 976 hours, 40 hours, 488 hours, 88 hours, 328 hours, 72 hours and 64 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 48 F (8.388888889 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)".This is one of several cases from the same reporter. Additional information has been requested.
Pfizer 9/15/21, 10/13/21. Positive on 9/20/22.
The pt experienced redness and swelling at injection site immediately after administration lasting 45 minutes. Ice pack applied to site. Observed for systemic reaction. No observed.
Atrial fibrillation, 2 episodes, duration increased. Subsequently put on Zarelta 20 mg
I am Having skin rash and allergic reaction . It started after first day of taking first dose. The symptoms have been going on and spreading in the rest of my body. Yesterday I suppose to take dose two , the doctor at Medical Center didn?t suggest to proceed with vaccination dose two since I was having allergic reaction
Patient presenting to clinic after receiving second dose of his Moderna CoVID-19 shot.  Patient with previous history of angioedema with various other vaccinations including the first dose of Moderna.  Patient has been previously worked up by allergy/immunology for his recent reactions, has been placed on Zyrtec 10 mg daily along with other antihistamine for the last 24 hours as premedication for this second shot.  Patient states that previously he has had to go to the ED for angioedema, has pictures with him.  He usually receives IV prednisone and observation.  Patient states that the prednisone resolves his symptoms almost immediately.  Today he is only complaining of some perioral tingling.  With the first dose of the vaccination patient states that he had perioral tingling, some lip swelling, and abdominal discomfort.  Patient denies any trouble with swallowing, swelling, tongue swelling, speaking, shortness of breath, or chest pain.
swollen glands; itchy; sore throat; eyes swollen; dry cough; headache; runny nose; tired; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 at 17:30(at the age of 58-years-old) administered in Arm Right as a single dose for COVID-19 immunisation. Medical history included Diabetes, high blood pressure, sarcoidosis, overweight, fibro, latex allergy (all from an unknown date and unknown if ongoing). Concomitant medication(s) included Metoprolol, pantoprazole, levothyroxine sodium (TIROSINT), vitamin d, acetylsalicylic acid (ASPIRIN E.C.), losartan, amitriptyline, insulin lispro (HUMALOG), canagliflozin hemihydrate, metformin hydrochloride (INVOKANA DUO), insulin degludec (TRESIBA), linaclotide (LINZESS) (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 27Feb2021, the patient experienced legs felt itchy, next day sore throat and eyes swollen and headache. Day 2 headache, sore throat, runny nose. Day 3 Headache and dry cough, swollen glands. Day 4 dry cough, nose running, tired.No treatment was given for the events. The outcome of the events was not recovered.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Injection site red, swollen and hot to touch.  Perimeter was marked and area continued to grow. PA was seen 10/03/14 and deemed a site reaction to injection.  Advised to apply ice.
Full body ache, mainly legs and injection arm, lasting 36 hours; Extreme fatigue lasting 48 hours; shortness of breath and chest tightening lasting more than 72 hours; irregular heart beat 48-72 hours after injection; diarrhea lasting 24 hours; Left ear infection appearing 48 hours after injection.
Client here with parents for initial Pfizer Covid vaccine dose. Client reported to nurse prior to vaccine being given that he had a "shrimp allergy and had to go the hospital one time." Mom and client are unsure if he had an anaphylactic reaction or not. Pfizer vaccine was given at approximately 4:10 pm per LPN. Client tolerated well.  Client and parents were asked to wait in the lobby for approximately 30 minutes due to his reaction to shrimp. At approximately 4:22 pm, mom brought client to door of child lab and client was holding his chest and stated "I feel like I can't breathe and my hands feel funny." Had client to sit in the chair, he was breathing very rapidly. Continued on continuation page. Respirations approximately 32-34 per minute. Denied any itching or feeling like tongue swelling. Observed client's tongue, appeared normal. Pulse oximeter was applied to finger and oxygen saturation was 99% on room air. Heart rate was 134. Client still continued to complain that he did not feel good and oxygen was applied via nasal cannula at 2 liters per minute at 4:24 pm. Heart rate was 120 at 4:26 pm. At 4:27 pm-Blood pressure was 120/60, heart rate 123. EMS was also notified at 4:27 pm. Client continued to talk to nurses without difficulty, was alert, and was encouraged to take slow deep breathes. At 4:28 pm-He stated that he "felt weird and my feet are numb." Oxygen increased to 3 liters per minute. 4:30 pm-BP 110/54, oxygen saturation 99%.  4:32 pm-Benadryl 12.5 mg/5 ml, 12.5ml given by mouth to client per nurse emergency protocol. Mother agreed for us to give.  EMS arrived at approximately 4:35 pm and began assessing client. Lungs were clear per EMS, client denied difficulty breathing, swelling of tongue or itching. Stated "I feel some better." EMS discussed taking client to ER to be evaluated; but parents and client declined. Client stated "I do not want to go to the hospital." Vitals per EMS at 4:43 pm were blood pressure 110/70, heart rate 86, temperature 99.3. Oxygen saturation was 99%. At 4:49 pm, heart rate was 80, oxygen level was 99%. EMS encouraged mom to give client more Benadryl later if symptoms returned or go to ER to be evaluated.  EMS left clinic at 4:51 pm. Oxygen removed from client. Oxygen saturation was 98% on room air, heart rate was 83. At 4:52 pm, oxygen level was 96%, heart rate was 81. At 4:53 pm, oxygen level was 98%, heart rate was 78. At 4:55 pm, oxygen level was 99%, heart rate was 78. Client was ambulated around the lab without any complaints of dizziness or shortness of breath. Client stated "I feel better." Client ambulated to car with parents without difficulty. Client and parents were encouraged to go to ER if symptoms return or any other changes. Verbalized understanding.
Injection site soreness, injection arm ache from shoulder to hand. Leg & arm muscle & join pain. Headache.
Extreme chellitis Extreme and chronic dry mouth  Extreme eczema from lower lip to neck
Sore throat and a cough; Sore throat and a cough; Mild regular cold symptoms; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1 SIN-GLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore throat and a cough and mild regular cold symptoms. It was reported that patient and her mother scheduled to receive the second dose of the Pfizer-BioNTech COVID-19, it was specified that they had no fever, and were tested for COVID but they don't have the results yet. Consumer was asked if they could get the second dose of the vaccine when symptomatic and if the vaccination series of the Pfizer-BioNTech COVID-19 vac-cine need to be repeated when the second dose was given beyond 40 days after the first and re-ceived response as in the Pfizer-BioNTech COVID-19 Vaccine clinical study, the second dose was al-lowed to be given 19-23 days after the first dose. Per CDC if the second dose was given later than 6 weeks (42 days), the vaccination series does not need to be repeated. The patient underwent lab tests and procedures which included COVID-19 test with an unknown result on an unknown date in 2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Expired vaccine used; Drug administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Drug administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Drug administration error). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Drug administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported No Treatment medications reported
pt states that 6 hrs p/recvd vax began to have chills, vomiting, sick to stomach x 2 days;
FLUBLOK was given to a patient of 17 years, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 17 years old male patient who was vaccinated with 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2028, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination either on 24-Sep-2020  or 26-Sep-2020. (PT: product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not given.   It was an actual medication error case due to due to inappropriate age at vaccine administration (same day latency).  No adverse event reported at the time of reporting.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Bexsero 1st dose, then as 2nd Trumemba; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   In October 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th November 2022, the patient received TRUMENBA. On 14th November 2022, an unknown time after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   It was unknown if the reporter considered the interchange of vaccine products to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Nov-2022 Reporter's Comment: Nurse Practitioner reported a male patient received first dose of Bexsero a month ago and came in 14th November 2022 for second dose but was administered Trumenba instead.  At the time of reporting the electronic medical record was not available for the Nurse Practitioner, so the reporter did not have the patient's age and date of birth.  However, she stated the patient was at least 16 years of age.  Reporter did not have the vaccine lot number or expiration date information. Additional Supportive Information: the patient received Trumenba vaccine instead of Bexsero, which led to Interchange of vaccine products.
Information was received from a female patient via a claims administrator who reported that she sustained a shingles outbreak after receiving the (zoster vaccine live) on 14-APR-2012. Additional information is expected.
Very fatigued; for the first 2-3 hours after waking up I would be lightheaded when I stood up.; Ears would start ringing; Vision was like static; Sounds became really quiet; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0162), via an unspecified route of administration in the left arm on 09Apr2021 at 18:45 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medication included desogestrel, ethinylestradiol (KARIVA) for birth control from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8727), via an unspecified route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 10:30, the patient experienced very fatigued (which the patient was expecting) but for the first 2-3 hours after waking up the patient would be light headed when stood up. If the patient stood up for longer than a few seconds, vision was like static and ears would start ringing. Once lay back down, the vision came back within a minute and the hearing was back to normal in 5-7 minutes. However, it happened every time the patient stood up and walked for the first 2-3 hours. The patient found that it was better after ate some food. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very fatigued, light headed, vision was like static, sounds became really quiet and ears would start ringing were resolved on 10Apr2021.   No follow-up attempts are needed. No further information is expected.
3Mar 500am taken to ER /p pt woke up /w seizure. Had pale spots Sunday. 5Mar pt is covered /w rash, pt had T /w seizure-much better even with rash, he has a hx of febrile seizure , sibs also has febrile seizures, Mom did too
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: numbness in arm shot was administered in
Swollen Left supraclavicular lymph node; Left supraclavicular lymph node, tender; Fatigue; Swollen arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen Left supraclavicular lymph node) and LYMPH NODE PAIN (Left supraclavicular lymph node, tender) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 07-Jan-2021, the patient experienced FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen Left supraclavicular lymph node) and LYMPH NODE PAIN (Left supraclavicular lymph node, tender). On 06-Jan-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. On 13-Jan-2021, LYMPHADENOPATHY (Swollen Left supraclavicular lymph node) and LYMPH NODE PAIN (Left supraclavicular lymph node, tender) had resolved. At the time of the report, FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Pt recv vax on 4/23/99; on same day pt exp break out of welts w/ itching
Intermittent dizziness and elevated temps (98.9-99.9) starting one week after injection and lasting one week.  Simultaneously experienced exacerbation of allergic rhinitis.
Phone call from parent @ 4:15PM. Stated pt. c/o scalp itching and stinging. Face red, dizziness noted. Mom stated pt. has had no fever, but she gave her Tylenol and called her doctor. Mom reports pts. pulse 114, BP 89/41. Mom reports pt. started her menses today. Asked parent to carry pt. to ER. Phone call from parent again. Stated she talked to their doctor and he said it was from the pertussis-Give Benadryl, was his orders. Onset of symptoms 4PM.
I developed floaters in my eyes. I went to eye Dr and was dx with Occular Cicatricial Pemphigoid. I had a biopsy of my eyeball and was given medication for treatment. My biopsy came back positive for this rare disease.
fever, chills, flu-like symptoms, couldn't stand, body aches, right arm pain, very weak, my whole body became violently ill
Covid 19 virus; Covid 19 virus; tired; feels like she has some congestion; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 2021 (at the age of 61 years old) (Batch/Lot number was not reported) as dose 2, single, the first dose via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included influenza vaccine (FLU) taken for an unspecified indication in Sep2021.  Patient received the shots in the spring (unspecified date in 2021) and at the beginning of Sep2021 she was hospitalized with the COVID virus for 15 days. Regarding the COVID virus, even though she was hospitalized, she mentioned it wasn't that severe. The patient clarified that she was actually hospitalized 2 separate times for 7 days each, once at the beginning of Sep2021 and once at the end of Sep2021. She was discharged on 01Oct2021. During this hospitalization she lost her vaccination card and mentioned she can't get her booster without her card. On an unspecified date in 2021, when the patient was asked if she has completely recovered from COVID she said she was real tired and feels like she has some congestion but is feeling much better. She will be going to her doctor next week regarding this. The event COVID virus resulted in an emergency room and physician office visit, the rest of the events resulted in a physician office visit. The outcome of the events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
tested positive for COVID/slight cough.; This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (tested positive for COVID/slight cough.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability NOS (severely disabled).    On 09-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced COVID-19 (tested positive for COVID/slight cough.). At the time of the report, COVID-19 (tested positive for COVID/slight cough.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) positive.         Concomitant medication list was not provided.  The reporter stated that she took care of a severely disabled adult (the patient). The patient had second booster on 09-May-2022. On 16-Aug-2022, patient tested positive for COVID-19. Patient had no fever, appetite stayed fine. Patient had a slight cough. They patient was quarantined for 10 days, and the cough went away.  Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a 55-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 3 months after receiving a dose of mRNA-1273 vaccine (reported as second booster of COVID-19 vaccine). The patient had symptom of slight cough. The patient was quarantined for 10 days and the cough went away. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 3 months after receiving a dose of mRNA-1273 vaccine (reported as second booster of COVID-19 vaccine). The patient had symptom of slight cough. The patient was quarantined for 10 days and the cough went away. The benefit-risk relationship of mRNA-1273 is not affected by this report.