chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; hives from head to ankles/ I look like a burn victim.; miserable and itches like mad.; anxiety; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's dad and daughter suffered with shingles and it was extremely painful).   In April 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, between 3 and 4 months after receiving Shingles vaccine, the patient experienced allergic reaction, hives, pruritus and anxiety. The patient was treated with antihistamine. On an unknown date, the outcome of the allergic reaction, hives, pruritus and anxiety were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, hives, pruritus and anxiety to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine in April and the patient had allergic reaction to which the patient was still dealing with at the end of August. It started out in hives from head to ankles and the hives spread out until their edges met and at the time of reporting, the patient looked like a burn victim. The patient stated fortunately, though it looks quite painful it was not but it was absolutely miserable and itched like mad. The patient also mentioned that most days his/her anxiety level from itching was through the roof. The patient used Anti-histamines but they were ineffective. The patient being seen by dermatology but treatments had been ineffective. The patient stated he/she still encouraged folks to get the vaccine. Having a reaction like what patient had was a long shot.
Joint pain started the following day after second dose of vaccine. Most noticeable in elbow joints, and knees. Still having fairly consistent joint pain in knees and elbows.  I have a very physical job and have always been very fit and active and never experienced joint pain like this. Other joints become painful with strenuous use when that same kind of use never caused joint pain before.  This very distinctly started the day after my second vaccine. Other reactions if relevant were a mild fever which also occurred after the first dose. And became sick with a sinus infection immediately following the second dose which resolved in about 12 days.
This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (Diagnosed with breast cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Tumor (She had tumor before getting the vaccine). In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Diagnosed with breast cancer) (seriousness criterion medically significant), ILLNESS (Sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). At the time of the report, BREAST CANCER (Diagnosed with breast cancer) and ILLNESS (Sick) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. During chemo she was sick, so she did not get the 2nd dose at the scheduled time. This is a spontaneous case concerning a female of unknown age with a medical history of "tumor" who experienced the serious (medically significant), unexpected event of breast cancer. The event began at an unknown time after the first dose of RNA-1273. No testing is reported and the treatment is chemotherapy. The outcome is unknown. The history of tumor is a confounder as the event is likely the same tumor given the short time after vaccine the event was diagnosed as it is medically improbable the event could have been caused by the vaccine and been diagnosed in the time frame. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a female of unknown age with a medical history of "tumor" who experienced the serious (medically significant), unexpected event of breast cancer. The event began at an unknown time after the first dose of RNA-1273. No testing is reported and the treatment is chemotherapy. The outcome is unknown. The history of tumor is a confounder as the event is likely the same tumor given the short time after vaccine the event was diagnosed as it is medically improbable the event could have been caused by the vaccine and been diagnosed in the time frame. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot #, expiration date, dose and route were not reported). No adverse effects were reported. RECOMBIVAX HB was supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Loss of taste; Loss of smell; Fever; Chills; Body aches; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), PAIN IN EXTREMITY (Arm was sore), PYREXIA (Fever) and CHILLS (Chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 25-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). On 26-Mar-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 25-Mar-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. On 26-Mar-2021, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved. At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
2ND DOSE WAS ADMINISTERED TOO SOON - PRIOR TO 6 MONTH MINIMUM INTERVAL. PER CHILD'S MOTHER NO ADVERSE REACTION OCCURRED FOLLOWING THIS DOSE OR THE DOSE HE RECEIVED AFTER.
couldn't move, felt paralyzed; malaise; sore arm; Fever; body aches everywhere; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (couldn't move, felt paralyzed), MALAISE (malaise), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and MYALGIA (body aches everywhere) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (couldn't move, felt paralyzed), MALAISE (malaise), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and MYALGIA (body aches everywhere). At the time of the report, MOVEMENT DISORDER (couldn't move, felt paralyzed), MALAISE (malaise), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and MYALGIA (body aches everywhere) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
p/vax pt devel chickenpox;pt was described as being covered from head to toe w/a fever up to 103;
Tender, 3 inch diameter, red area around shot area, for the past 2 days.
Hashimotos; Caller reports she received the vaccine in her butt and whenever she took the bandaid off it was full of blood; Caller reports she received the vaccine in her butt and whenever she took the bandaid off it was full of blood; blood pressure being up; shaking; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 03May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hypothyroidism. The concomitant medications were not reported. On an unspecified date, she received the vaccine in her butt and whenever she took the band aid off it was full of blood. On 06Jun2021, she had her blood pressure being up for no reason and she was shaking for 1.5 hours. On an unspecified date, she was diagnosed with Hashimoto's. On 06Jun2021, the patient went emergency room (ER) for blood pressure being up for no reason and shaking. The reporter reported that, took the band aid off it was full of blood. On 06Jun2021 Patient reported she had to call 911 due to her blood pressure being up for no reason and she was shaking for 1.5 hours. She was taken to the ER. She has now been diagnosed with Hashimoto's. Patient seeking information if others have reported this symptom. The lab data included blood pressure was increased on 06Jun2021. Outcome of the events was unknown.; Sender's Comments: The event of Hashimoto's thyroiditis is assessed as possibly related to the suspect drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pain/stinging at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. On 17th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age at vaccination was captured as adult as per Shingrix indication. The reporter mentioned that she gave 3 Shingrix vaccinations on day of reporting and all 3 patients had complained of pain/stinging during injection of the Shingrix dose. The reporter consent to follow up. This is 3 of the 3 linked cases reported by the same reporter. This case had been linked to the case US2019188954, reported by same reporter.
she noticed huge lump under armpit of her left arm/Have a big lump a swelling lump under my armpit and in the same arm that I had the COVID shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY MASS (non-serious) with onset 03Apr2021, outcome "unknown", described as "she noticed huge lump under armpit of her left arm/Have a big lump a swelling lump under my armpit and in the same arm that I had the COVID shot".  Additional information: She wanted to know if that was something that was reported with the vaccination. She indicated that a lump was going down. NDC number, UPC number and expiry date were reported as unknown. She had a big lump a swelling lump under armpit and in the same arm that she had the COVID shot and she still feel the swelling and it left but she was a little concern and believed that it could be a side effect from the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine helped lessen the severity/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 24-JAN-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Vaccine helped lessen the severity/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The patient was just diagnosed with shingles on the day of reporting (on the post day).  The vaccine helped to lessen the severity. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Day after vaccine, patient reports nausea, chills, Joint Pain, Muscle Soreness, Dizziness.  The following morning patient reports feeling much better, just soreness at injection site.
Pt received Yellow fever in Left SQ area, experienced redness, warmth, swelling, and pruritis shortly after. Seen at clinic by MD.  Sent to Urgent care center.  Received medications and was sent via ambulance to local ER.
Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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 Pharmacist gave 2nd dose of expired vaccine to 6 different patients. Vaccine was placed in refrigerator on 07MAY2021 for over 30 days. They administered vaccine 15JUN2021. Box was in fridge and they inadvertently grabbed without realizing the expiration date.   This case was linked to MOD-2021-222826, MOD-2021-223023 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955), on 10Apr2021 as dose 2, single (Lot number: EW0153) and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 37 years for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Tree nuts" (unspecified if ongoing), notes: Tree nuts. Concomitant medication(s) included: LISINOPRIL, start date: Jan2013; AMLODIPINE BESYLATE, start date: Jan2013; METFORMIN, start date: Jan2017; METOPROLOL, start date: Jan2019; CANNABIS, start date: Jan2018; DAYQUIL, start date: 19Apr2022, stop date: 22Apr2022; NYQUIL, start date: 19Apr2022, stop date: 22Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected Covid-19.
Arm swelling (unusually large), sweating, dizziness, and nausea developed later in the evening the day of vaccination. The next morning the swelling "moved" down arm and formed a bubble. All symptoms resolved after a couple of days.
PATIENT CAME TO PHARMACY COMPLAINING WITH PAIN AND SWALLOWING IN THE RIGHT ARM WHERE SHE RECEIVED BOOSTRIX VACCINE.
Pain at injection site x 4 days.   As of 8 Feb, 7 days post immunization I still have a red, firm area approximately the size of a 50 cent piece at the injection site
3:30 pm, 18 hours after second shot, very tired. I took a 200mg ibuprofin, and took a good nap as soon as I could (2 hrs after I took pill). Also sore arm for about 36 hours
Pt received pneumonia vaccine on 3/4/13 after routine exam, along with influenza and TDAP. Only pneumococcal given in RT arm. On 3/6 pt came to urgent care with red, inflamed area on (R) arm 29 x 16 cm, hot to touch. No fever, but positive for fatigue and chills. Given Cephalexin 500 mg QID.
Presented 2/25/21 with right arm swelling, redness, warmth to palpation, most apparent around right elbow. Normal range of motion of right arm without pain. No pain to palpation of right arm. Also had pacemaker surgery 2/11/21. Patient was referred to healthcare facility for further evaluation.
that vaccines cause cancer; sick; This spontaneous report has been received from a consumer via Pfizer referring to her mother of unknown age.  The patient's concurrent condition, medical history and concomitant medication were not provided.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot#, expiration date, dose and route were not reported) for prophylaxis.  Other suspect therapies included tetanus vaccine.      On unknown dates,  the patient experienced sick and cancer. The outcome of the events was unknown. The patient believed that the vaccines made her (captured in MARRS# 2109USA005483) and her mother sick and caused the cancer.; Sender's Comments:  US-009507513-2109USA005483:
Felt like she had a tetanus shot.  Her arm is still hurting very bad even though she was administered the shot over 30 days ago.
Pain (hardness and burning sensation) in the left arm (injection site) in the lymph nodes in the back of the arm.  Still occurring 4 days after receiving the injection.
Received Boostrix instead of Kinrix; A 5 years-old received Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 397B5, expiry date 30th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 19-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a Boostrix dose instead of Kinrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Local redness, pain and warmth of injection site. Some itching. Local swelling (R) deltoid injection site. No fever. No wheezing.
Tinnitus.  Historically I would get Tinnitus once or twice a year and it would be pretty mild would be intermittent throughout the day primarily only in the evening and would only last a day maybe two.  Since receiving the shot it has been much worse.  I did not make the connection to the vaccine until someone at work indicated that this was a possible side effect. I had been complaining over the last two weeks to my wife about the Tinnitus being really bad and not understanding why. Unlike in the past it's not only much more pronounced but it has persisted.
fever; fatigue; body aches; headaches; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and ABDOMINAL PAIN UPPER (stomach pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, PYREXIA (fever), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
blotchy red rash with spots on neck, abdomen and back areas.  Slight fever on 2/8/07 of 102f. Had loss of appetite and a runny nose. Rash does not seem to itch or bother pt.  Mom gave Motrin for fever which helped her.  One site had "bright redness and bumpy"