chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Kinrix either under age 4 or after their 7th birthday; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patients received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patients experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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: 7-Feb-2023 Reporter's comment: The patient safety associate (non-health care professional) mentioned that multiple children received Kinrix either under age 4 or after their 7th birthday. Nothing else was reported. Unknown patient identifiers. The reporter declined to give her contact information or details of adverse event. Additional supportive information: The patients received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Headache; itchy rash near the injection site; red bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (red bumps) and HEADACHE (Headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash near the injection site) and VACCINATION SITE RASH (red bumps). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (red bumps) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information included Calamyl, ice and water and soap.
Slept a lot after vaccination day, noticed a cyst like formation on her hand a few days later. Almost feels so hard its a bone. Doesn't show up on x-ray and doctors nor her orthopedic surgeon don't know exactly what it is.
DEVELOPED SORENESS IN ARM, EXTREME FATIGUE, AND BODY ACHES.
got sick; Unusual feeling in the muscle; aching and was so painful; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media on 12-Nov-2020.  This case was linked to case 2020SA322882 (Case for husband).  This case involved a female patient of an unknown age who got sick (Illness), and experienced unusual feeling in the muscle (Muscle discomfort) and was aching and was so painful (Pain), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer lot number not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got sick (Illness) and unusual feeling in the muscle (Muscle discomfort) and was aching so painful (Pain).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown.  There will be no information available on the batch number for this case.
This spontaneous report was received from a 57 year old female patient, reporting on herself. The patient medical history included reoccurring shingles. On 12-JAN-2016, the patient was vaccinated with ZOSTAVAX, 1 shot for the treatment of reoccurring shingles (route, anatomical location or lot # were not provided). Concomitant medications were not reported. On 19-MAR-2016, the patient experienced shingles. No treatment was given for the event and the patient was not hospitalized. The patient sought for medical attention by calling the office. No product quality issue was informed. At the reporting time, the outcome of shingles was reported as not recovered. The relatedness between the event and suspect therapy was not provided. Additional information is not expected as no contact information was provided.
Pt recvd vax & four to five hrs dose exp hives; sx subsided;
Moderna COVID-19 Vaccine EUA Rash on right deltoid formed 8 days after receiving the Moderna COVID19 vaccine. Was not itchy or painful or abnormally warm to touch.
Resting heart rate 135 and racing heart after injection.  Resting heart rate continues to be high two days after injection with racing heart and shortness of breath upon walking.
Both of my little fingers started cramping and my hands look like I have broken little fingers or rheumatoid arthritis. I don't have RA.  Also my right big toe area and down into my middle of my right foot started cramping.  I received the vaccine at 2:16pm today and this started t 5:03 pm. I drank about 6 ounces of powerade and took 1/2 tablet of potassium.  I thought the magnesium in the powerade and maybe the potassium would help reduce the cramping. Also, massaged the 3 areas and reduced the cramping. It came back around 6 pm and it's now 7 pm and it feels like I could set it off to cramp if I move wrong by accident.
About 3 days after the Moderna booster shot I starting to see a rash on my stomach, then back, then arms and legs. It's nearly an entire body rash that is mostly on my stomach and back. I went the dermatologist and they aren't sure what it is. They haven't seen anything like it other than Pitaris Rosacea. They didn't take a biopsy to know, but it's quite strange that the only thing that changed during this time period was getting the Moderna shot. I didn't have a reaction other than this rash. My first shot was in April with the J&J shot and I didn't have this reaction. I had zero symptoms. The rash is still here and it's been 3 weeks. I think it's getting better but not sure?
Bell's palsy; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced bell's palsy 2 weeks after receiving Pfizer COVID vaccine on an unspecified date with outcome of unknown.  Event took place after use of product. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event Bell's palsy cannot be completely excluded based on temporal association.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
7/8/2022 started with a Sore throat and stuffy nose with sneezing. Tested positive with At Home Rapid COVID 19 test.  7/9 Sore throat disappeared. Saw doctor, diagnosed COVID-19 with rapid test. Prescribed Paxlovid, but that was not taken. 7/10 Lost sense of smell. 7/14 sense of smell returned. Recovery felt by 7/20.
E87.1 - Hyponatremia N17.9 - AKI (acute kidney injury)  R56.9 - Seizure-like activity
With-n 10 minutes I had extreme nausea, clammy skin. Nausea progressed until I had to take Zofran to control it. A few hours later I began to feel pressure in my ears and throat as well as head to toe itchiness. Ear and throat pressure subsided after taking an antihistamine, but the itchiness remained until the next afternoon. I did not seek medical attention for any of these reactions.
This spontaneous report was received from a physician, via company representatives, and refers to a patient (encounter key # 390463) of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 14-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 32 F for 48 hours (lowest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Large swelling and redness, gradually increased over 3 days. Today site is 15cm by 8 cm. Treated with 1 tsp Benadryl PO.
Woke up at 3/29/2021 with severe itching, flat reddened patches on arms, chest, back and legs. I also had and raised reddened (pea to dime sized) hives on my arms, legs and chest.  I thought that it was an allergic reaction to several insect bites from being outdors Sunday evening for about an hour. Allegra and Zyrtec didn't help the itching very much, so I've been taking Allegra every 10 hours and Benadryl every 6 hours for the past 48 hours.  When the Benadryl wears off the hives return become raised, red and very itchy.  I didn't think that it could be from the vaccine because I didn't really have any issues other than local swelling and itching at the ilocal area of the vaccine njection site.  I've also been treating the hives with topical Hydrocortisone cream and Benadryl cream.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 12-MAY-2015, the patients was vaccinated with a dose of (Merck) PROQUAD lot # K020747, expiration date: 30-APR-2016 (dose and route were not reported, that underwent temperature excursion of 25 Fahrenheit (F) for 41 hours. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
320PM on 6JUL94 woke up from sleep, shivered gasp for breath, eyes went to back of head pt went limp & father ran to hosp; pt was crying; 7JUL94 pt has vesicles in back of throat
I got very tired and I felt achy. I started feeling a tingle and numbness in my hands and fingers. I had pain around the base of my thumb on my left hand.
While vaccine injected, felt like a glob of glue was injected.  Immediate injection site pain.  Pain continues in injection site.  Cannot lift arm over head to dress, comb hair.  Pain wakes me up while sleeping at night.
Within an hour of vaccine, itching at injection site. Within 6 hrs, body was itching with red patches. Noted slight fever. By next day, 3.5? (diameter) raised red bump at injection site. 36 hrs after injection, noted sever small red bumps (resembling bug bites) on neck and back.
I had no problem with the pain in my arm, but the dizziness and shallow breathing did concern me along with feeling incoherent. I started with the dizziness about 6 hours after the shot, followed by chills, extreme fatigue, severe muscle aches and then feeling out of it for the next 4 days. I cancelled all plans for the weekend and rested. I am concerned about whether or not to get the 2nd shot...I have never had such a horrible reaction to a vaccine before.
Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Flu like symptoms came on suddenly. Sore throat, cough, runny nose, up-chuck. I went to pharmacy for medicine by time I returned home conditions worse. At 8PM she went to Emergency Room.
itchy site of injection; pink circle at the site of injection; dizzy; red arm of injection; swollen arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm of injection), VACCINATION SITE SWELLING (swollen arm of injection), VACCINATION SITE PRURITUS (itchy site of injection), DIZZINESS (dizzy) and INJECTION SITE DISCOLOURATION (pink circle at the site of injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes and Hypertension.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm of injection), VACCINATION SITE SWELLING (swollen arm of injection) and DIZZINESS (dizzy). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy site of injection) and INJECTION SITE DISCOLOURATION (pink circle at the site of injection). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red arm of injection), VACCINATION SITE SWELLING (swollen arm of injection), VACCINATION SITE PRURITUS (itchy site of injection), DIZZINESS (dizzy) and INJECTION SITE DISCOLOURATION (pink circle at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
SUSPECTED COVID-19 INFECTION; SEVERE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for covid-19 prophylaxis. Age at time of vaccination 53 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-JUL-2022 23:15, the patient experienced severe allergic reaction. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from severe allergic reaction, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Small blood vessels in arms and legs broke-severe joint pains all over my body. Headaches. Eye problems. Treated with high dosage of prednisone and methotrexate for one full year. Chronic reoccurrence to this day. Has left me at constant joint pain. Tests indicated vasculitis RA (never had any symptoms before vaccine).
rash in her leg/ she has one big patch and smaller patches of this rash; has had a headache; she also feels very cold; This is a spontaneous report from a contactable consumer. A 68-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported she was experiencing a rash in her leg, she also feels very cold and has had a headache. She said that her physician didn't consider the rash serious and recommended applying either calamine or a hydrocortisone cream, and that the rash hasn't moved to other parts of her body although she has one big patch and smaller patches of this rash. Patient wanted to know if rash is a common side effect with Prevnar 13 and if it resolves eventually. Outcome of the events was unknown.  Information on the batch number has been requested.
A patient did not receive their second dose of the Moderna COVID-19 vaccine, first dose received in February 2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient did not receive their second dose of the Moderna COVID-19 vaccine, first dose received in February 2021.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (A patient did not receive their second dose of the Moderna COVID-19 vaccine, first dose received in February 2021.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (A patient did not receive their second dose of the Moderna COVID-19 vaccine, first dose received in February 2021.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.  The patient was not experiencing any symptoms currently.
Per Mom and Dad; reporting to us today at well check visit that on 10/21/08 approx 1900 pt had fever of 104, responded to treatment of TYLENOL, in am fever again of 102 and then that evening of 10/22/08 patient cried for 5 hours (9pm to 2pm) went to Hospital ER at 12 midnight (will provide copy).
This spontaneous report was received from a 71 years old female patient with allergy to COMPAZINE and no pertinent medical history. The patient was vaccinated subdermally with a dose of ZOSTAVAX on 04-JUL-2012. Concomitant medication included "cholesterol medication and a slow metabolism". The patient reported that she got shingles immediately after getting the vaccine and had had the shingles on her body since 12-JUL-2012. The outbreak was on the back, chest and upper left arm. The patient had sought unspecified medical attention. The outcome of shingles was unknown. Additional information has been requested.
2nd dose given more than 35 days after 1st dose; back of my head is swollen; 3 hours after vaccination, she felt like the liquid was going up to her head; feel weak/weakness; I have temp (fever); Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 037F81A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN POTASSIUM for an unknown indication.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)), CHILLS (Chills), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 35 days after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 35 days after 1st dose) had resolved. At the time of the report, SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Rash on the inner arm where vaccination was given.  Starts at the wrist and extends almost to the armpit.  Red, flat, small and blotchy.  It also itches. Came on within 24hrs of shot.
A report had been received from a health professional concerning a female patient of age 36 years. The patient's concomitant medication included ascorbic acid, biotin, minerals NOS, nicotinic acid, retinol, tocopherol, vitamin B NOS, vitamin D NOS. The patient reported her last menstruation on 20-Aug-2012, and the patient was administered nasal FLUMIST on 14-Sep-2012, when she was pregnant. It was reported, that FLUMIST was administered to 3 pregnant patients. It was reported that the patient experienced complications during the current pregnancy however, no additional details were provided. The patient had two previous pregnancies excluding the current one. Live birth and normal delivery were reported in previous pregnancies. Action taken with FLUMIST, were unknown. The company physician assessed the event of complications during the current pregnancy to be serious with the serious criteria of important medical event and the event of FLUMIST was administered to 3 pregnant patients to be non serious. Corrected report on 20-Nov-2012: The event of administration to 3 pregnant patients has become a KUR term, therefore the case has been updated accordingly. Summary of follow up information received by AstraZeneca/Medimmune on 18-Dec-2012: Patient's initial, date of birth added. FLUMIST start date updated, concomitant medication added. New event of patient experienced complications during the pregnancy was added. Trimester exposed added. Patient's last menstruation date, pregnancy due date updated. Number of previous pregnancy added as 2. PSUR comment added. Narrative updated. Follow-up information received by AstraZeneca 20-Dec-2012 from health professional upgraded this case to globally expeditable: Serious criteria changed for the event of patient experienced complications during the pregnancy.