chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Headache; Tired; I started feeling bad; My joints hurt very bad, I have got pain in my joints; something and it itch; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; I felt like I kind of had a bad cold, like a flu; I felt like I kind of had a bad cold, like a flu; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 39-year-old unspecified gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8731, Expiry date: unknown) via an unspecified route of administration in upper left arm on 12Apr2021 (at the age of 39- year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Methadone and Citalopram Hydrobromide (CELEXA)] both are from an unknown date for an unspecified indication unknown if ongoing. On 16Apr2021, the patient experienced breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red, I felt like I kind of had a bad cold, like a flu, but I didn't expect to have breakout on my legs, and on an unspecified date, patient got fever, headache, patient also stated I am really tired, Yesterday or maybe Thursday, it was when I started feeling bad, my joints hurt very bad, I have got pain in my joints, it has just got unbearable. Therapeutic measures were taken as a result of the events which included Benadryl, Ibuprofen like Advil and also patient stated he used some Hydrocortisone, it was a cream. Patient bought some Benadryl last night, which was an antihistamine because, thought it might be some allergy, patient don't know, and then got some Ibuprofen like Advil. So, patient just took over the counter medications and also used some Hydrocortisone, it was a cream. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Vaccination was at 8:15am. At 5:30pm, patient states she had a "wierd sensation in my throat", "started having a difficult time breathing, and wheeze". Patient states she felt like she couldn't breathe. By 6:00pm a cough started, at 9:30pm "was completely congested". At 6pm called provider friend who suggested patient "use an Albuterol inhaler, Benadryl normal dose and take a hot shower" and that is what she did. "Breathing became easier after that", cough persisted and was congested. The wheezing resolved that night, and breathing improved. The next day patient was congested, had a cough and the tops of her feet were "extremely itchy".
vaccine on a 230 pound female,  used a 1 inch needle, not confident that it reached the muscle; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5723N, expiry date 19th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process and inappropriate route of vaccination. On an unknown date, the outcome of the wrong technique in product usage process and inappropriate route of vaccination were unknown.   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: 8-Apr-2022 Reporter's comments The registered pharmacist administered Boostrix vaccine to the patient and used a 1 inch needle. The reporter was not confident that it reached the muscle and was wondering if he should repeat the dose. The consent to follow up was given via postal. Additional Supportive Information: The pharmacist administered Boostrix to a patient, and used 1 inch needle and reporter was not confident that it reached the muscle, which led to wrong technique in product usage process and inappropriate route of vaccination.
On 2/8/21, 2 days after vaccination, itchy redness appeared approximately 3 inches down from injection site on left arm. The redness grew to approximately 3 inches vertically and 2.5 inches horizontally. Redness was still there today 2/12/21 and patient reports warmth over area.
The patient is has several red, itchy raised bumps on her right leg and feels a burning sensation for 7 days. She has not treated it yet. She will apply hydrocortisone 1% cream to the affected area
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021 at 1:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:37 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 56.39.  Concomitant products were not provided.  For Lot no 030B21A on 03 Apr 2021, excursion time was 9 AM and temperature was 34 respectively, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021 and was moved to clinic on  03 Apr 2021. 20 vials was sent to clinic. Vaccine BUD date was 29 Apr 2021. For Lot no : 030B21A vial was stored on cooler 1 , on 03-Apr-2021, Excursion duration At 8 Am: 38, 9 AM: 34 , 10 AM: 38 , 11 AM: 42, 12 AM: 41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40, 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced myalgia, influenza-like symptoms and chills. On an unknown date, the outcome of the myalgia, influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the myalgia, influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The health care professional mentioned that the patient mentioned having worse myalgia, flu-like symptoms, including chills. The reporter did not consent to follow up. For tolerance to 2nd dose, refer case US2019GSK055935.
Pt received vaccine on 6/27/12, then presented to hospital after pain and redness in left arm. Pt was diagnosed with cellulitis and was prescribed antibiotics. Pt was unable to pay for medications and then presented to ED for medications. ED notes described redness, warmth and some proximal swelling. Treatment: Clindamycin 300 mg QID, Ibuprofen 600 mg TID.
stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.            Concomitant product information was not provided by the reporter.   It was reported that patient had a stroke following the second moderna shot.  Treatment information was not provided.  Company comment: This is a spontaneous case regarding a male patient of an unknown age, with no reported medical history, who experienced unexpected and medically significant event of cerebrovascular accident (AESI) after receiving mRNA-1273 vaccine, reported as the second dose of the COVID-19 vaccination schedule. Vaccination date and onset date of the event were not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-698692.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698692:
On 10/17/1999, the pt experienced a red, hot, indurated arm distal to the injection site
Parent was told pt was due for next dose of Menveo but it was too early (not due until 2025). Vaccine was prepped.   Administrator saw vaccine was highlighted on sheet, and those vaccines were pulled and prepped on tray. Vaccines were administered. Administrator realized mistake was made when vaccines were placed into chart and came up as "NOT VALID".  Mom was notified by administrator of vaccine of mistake [while still in office]. Apologized and advised PCP and supervisors would be made aware. Mom verbalized understanding. Explained writer was unsure if this would be pt would still need another dose later on (when it was supposed to be due at age 16-18 yrs).".  Manufacture was consulted for guidance.  Patient was not exhibiting any signs or symptoms of side effects to date.
This started with allergy symptoms Scratchy throat, headache, and feeling bad.  12/22/22 At Home COIVD-19 Test, positive.  Televisit with doctor, who proscribed Lagevrio.  Within a few days, symptoms were greatly diminished.  Once prescription ran out, I felt recovered from COVID-19, but I experienced some other infections, ear, UTI, stye in both eyes in the months that followed.
Pt. reported having an allergic reaction (eyes are swollen and later scattered hives). She received Hep A and YF AM and took one oral typhoid 2:30 pm on 6/6/17. She had taken BENADRYL, which helped.
Mom states - "The day after the flu shot he started to swell all over".  No respiratory distress or wheezing.  "Also developed a fine, red rash".  Mom gave Benadryl and went to ER.  Rash and swelling went away that same day.  Mom states she knows what hives look like and was not hives.
Blood pressure elevated from norm of 90/60 to 179/100, lethargy, disorientation, low respiratory rate, slurred speech
Pain; Rheumatoid arthritis flare up; This is a solicited report from a marketing program (FACILITATED COLLECT) based on information received by Pfizer (manufacturer control number: 21K-163-4116776-00) form a contactable consumer (patient).  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular on 24Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 11Jun2021 (Batch/Lot number was not reported) and ongoing, at citrate free, 40 mg, 1 in 2 wk for moderate to severe Rheumatoid arthritis. Medical history was not reported. Concomitant medication included methotrexate taken for an unspecified indication, start and stop date were not reported. In Sep2021, the patient experienced rheumatoid arthritis flare. On 24Sep2021, the patient experienced lot of pain. On 29Sep2021, the lot of pain resolved. In Sep2021, the rheumatoid arthritis flare resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of events was recovered. The action taken in response to the events for adalimumab was dose not changed. The reporter's causality for the events of lot of pain and rheumatoid arthritis flare with adalimumab was not provided. The reporter's causality for the events of lot of pain and rheumatoid arthritis flare with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information and a possible contributory role of the suspect product BNT162B2 to the development of the Rheumatoid arthritis and pain cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
SVT; Respiratory problems; This is a spontaneous report from a contactable consumer (patient himself). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er2613), via an unspecified route of administration, administered in left arm on 24Mar2021 (age at vaccination: 71 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included diabetes mellitus. The patient did not take concomitant medications (patient did not take any other medications within 2 weeks of vaccination). The patient's historical vaccine included bnt162b2 on an unknown date at 14:00 in left arm as DOSE 1, SINGLE for covid-19 immunisation. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 12:00, the patient experienced svt (supraventricular tachycardia) and respiratory problems. Onset of SVT within 5 days on second shot also respriatory problems. All the events were considered to be disabling. The event of svt was treated with medications. The adverse events led to Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. It was serios and seriousness criteria not resulted in death, life threatening, caused/prolonged hospitalization, congenital anomaly/birth defect but Seriousness criteria resulted in Disabling/Incapacitating. Prior to vaccination, the patient was diagnosed with COVID-19 nor the patient has been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The device date was 07Aug2021.  Follow-up attempts are completed. No further information is expected.
Dizziness/lightheadedness, started 15 minutes after injection, lasted 30 minutes. Did not recur with second dose
ON THE 2ND DAY AFTER RECEIVING THE FIRST DOSE OF THE MODERNA COVID 19 VACCINE... I BEGAN TO EXPERIENCE CHEST TIGHTENING THAT RADIATED TO NECK.  IT FELT AS IF I WAS BEING SQUEEZED.   I DID NOT HAVE A COUGH, FEVER, OR OTHER ASSOCIATED  S/SX.  IT JUST FEELS AS MY CHEST IS IN A VICE.  ON THE 3RD,,4TH AND 5TH DAY POST VACCINE ADMINSTRATION, THE SENSATION OF CHEST SQUEEZING HAS NOT RESOLVED COMPLETELY.  THE REASON I AM REPORTING THIS OCCURRENCE IS THAT SEVERAL CO-WORKERS THAT RECEIVED THE SAME MODERNA VACCINE HAVE SIMILAR COMPLAINTS.
My breathing got bad and I felt overall sick, but I did not have a fever on 06/18/2022 and I ended up going to the hospital. They did not do a COVID-19 test at that time because I told them about a recent knee surgery and they were concerned about a blood clot. They did multiple tests to rule that out and sent me home. The next day I was still having symptoms so I took an at home COVID-19 test which was positive. I called my primary care physician's office and discussed my symptoms. We decided against using the antiviral medication due to abnormal readings from my blood test that indicated elevated levels in my kidneys. I continued testing positive for COVID-19 until 12 days after my original positive results. Ultimately, although my symptoms were gradually improving, I ended up isolating for 2 weeks.
RASH ALL OVER BODY,  BACK, LEGS,  ARMS ETC. LOT # 1st 029A21A   Lot #2  dose 045A21A
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a Pfizer sponsored program. The reporter is the patient. A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster dose), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis w rheumatoid factor multiple site w/o org/sys involvement" (unspecified if ongoing); "Emphysema" (unspecified if ongoing). Concomitant medication(s) included: Albuterol [Salbutamol]; Anoro Ellipta; Caltrate 600+D3; Carvedilol; Epinephrine; Folic Acid; Furosemide; Isosorbide Dinitrate; Lipitor; Loratadine; Meloxicam; Methotrexate; Potassium; Synjardy XR; Triamterene and Hydrochlorothiazide; Vitamin C [Ascorbic Acid]; Xeljanz XR. Past drug history included: Aspirin, reaction(s): "Allergies: Aspirin"; Demerol, reaction(s): "Allergies: Demerol"; Lisinopril, reaction(s): "Allergies: Lisinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had corona virus"; PYREXIA (non-serious), outcome "unknown", described as "low-grade fever twice"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinuses were attacked". Patient said she had corona virus, low-grade fever twice, sinuses were attacked. She said she had Pfizer COVID vaccine and booster and still got corona virus. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RED HOT WELT, SIZE OF QUARTER AT 2PM, BECAME LARGER THROUGHOUT THE DAY AND THE FAMILY BROUGHT THEIR SON IN FOR THIS.
Redness and pain on IM injection site with progressive exacerbation noted 2days after administration.
had infection in July presumably due to the Delta variant; had infection in July presumably due to the Delta variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (COMIRNATY), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2021, outcome "recovering" and all described as "had infection in July presumably due to the Delta variant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Unknown results, notes: He had infection in July presumably due to the Delta variant. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: A 40 y/o music teacher who received 2 does of Comirnaty in Mar2021 with no appreciable adverse events. He had infection in July presumably due to the Delta variant and had sore throat, cough, headache, brain fog all resolving except for a chronic cough that responded to steroids after about a month. The pt received a booster dose in Feb2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, fever, malaise, fatigue, body aches, sweats, swelling and extreme pain at the injection site
Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfast around 8:45 am. Housekeeper reported seeing resident between breakfast and time found unresponsive. Resident had voiced no complaints. Code was initiated until EMS arrived and transported resident to hospital. Resident expired.
w/in 2 hrs of receiving immun, pt devel croup w/stridor; Seen in office & was given Hexadrol, then calmed down; @ time of event, there was a large amount of croup in the area;
Pain at site, nausea, HA, achy, low grade fever, unable to sleep.
Vaccine was administred intramuscularly rather than subcutaneously and reported cold like symptoms on 10/29/2014.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.   This case was linked to MOD-2021-405476 (Patient Link).
Woke the following morning with 102 fever, severe headache, and fatigue.  On Sunday onset lymph nodes under right arm swollen and painful.  On Tuesday, 1/12/21 reports improvement of swollen lymph nodes but has continued fatigue.