chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she did not feel totally right; some high blood pressure; she has an irregular heart beat; This is a spontaneous report from a contactable consumer (patient). The 77-years-old female patient received first dose of BNT162b2 (BNT162B2, lot number: EL3248), via an unspecified route of administration on 18Jan2021at SINGLE DOSE for covid-19 immunisation. Medical history included diagnosis of irregular heart rate prior to the vaccine, about 4-5 years ago, allergy, Cholesterol. The patient experienced some high blood pressure on Jan2021, she has an irregular heart beat on Jan2021. "I developed some high blood pressure after getting the vaccine." she has developed a very high blood pressure reading and that is unusual for her, states she went to a walk in clinic on Tuesday and then to the doctor today. Caller states that it really concerns her that someone who is medically savvy as she could have a serious problem. stated that she did not feel totally right while she was waiting afterwards, states that she came home and laid around and the next morning, she can tell when it is high because she is chronically low. Caller states the next morning the top number of her blood pressure was 166, states bottom number is never out of sync (AS REPORTED). Caller states she could feel it really bad yesterday, really bad states she took the pressure once and it was 182/94 and a little later it was 192/84 and that is when she went to the walk in clinic. Caller states she has an irregular heart beat and she takes a blood pressure medication to treat that, takes 25mg once a day at night time. Yesterday morning she took another one before she went to the walk in clinic to help treat the high blood pressure, so she had 50 mg in 12 hours; when she got there they checked it and it was 178/72.  She also takes an allergy medication and something for cholesterol that she has been taking for years. She called on 21Jan2021 around 5pm regarding the Pfizer covid vaccine. She called because she was having blood pressure issues and two different doctors thought it was covid vaccine related. It has taken since then till today to get a reasonable blood pressure. Her thoughts are not to get the second dose. She is asking if she will have any protection if she does not get the vaccine and if there will be any adverse effects if she goes not get the second vaccine. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Itching, red, painful raised rash over the right upper arm just distal to IM injection site.
Patient started to have abnormal movements of the upper limbs, and twitching her eyes in what was described as seizure like activity, continued on and off since then, happens more when she wakes up from sleeping or when getting excited, or crying. Nofever
Systemic: Fainting / Unresponsive-Mild, Systemic: pt was in chair in waiting area and fell out of chair when passed out 8 minutes after vaccine, pt had rug burn on left side of forehead, pt said felt ok and soemtimes passes out after blood work-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: i stayed with patient and asked the manager on site to get patients father from car. pt was responsive within seconds of going to him, pt was pale and said he was ok. patient remained in lying position on floor, I cleaned his forehead with alcohol swab that had "rug burn and helped him int ositting positon then standing slowly. patient was given gatorade and washelped to sit in chair and father came in and stayed with him. patient refused ambulanceand further care and was in good mood
Red, itchy pea sized bumps on nose, cheek, forehead, left wrist and right palm. Left side of face was swollen.
My right arm was sore fit about 3 days following vaccine and on March 28 my right under arm feels a sore and when I looked to see my lymph glands are extremely swollen and painful but not red.  It is now March 31 and it is a little less swollen but still tender.
patient developed a raised area of erythema at the site of the varicella vaccine administration on the right thigh within 5 minutes of administration. the area measured 3cmx2cm and was circumscribed with  a skin marker. patient was administered 12.5mg oral diphenhydramine and observed for 20 minutes. upon recheck the inflammation was the same size and patient was  discharged.
pain; I get pain in my upper arm; When I have both arms at my sides, my left arm feels heavier; Three days later, it all broke out again with the same 2-inch ring, swelling, soreness; swollen arm/2-inch ring around my arm; a small dot, like a mosquito bite type thing; Sometimes it feels numb and tingly all the way down to my fingers; Sometimes it feels numb and tingly all the way down to my fingers; some chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness) and PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness), PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm), INJECTION SITE MASS (a small dot, like a mosquito bite type thing), HYPOAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers), PARAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) and CHILLS (some chills). At the time of the report, PAIN (pain) and INJECTION SITE MASS (a small dot, like a mosquito bite type thing) had not resolved, PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), HYPOAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) and PARAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) outcome was unknown and VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness), PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm) and CHILLS (some chills) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Local redness, pain and swelling of right deltoid beginning evening of day received pneumococcal vaccine.
a patient received two doses of the GARDASIL 9 vaccine in the same day inadvertently; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient inadvertently received two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (product quantity: 1; strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis in the same day (extra dose administered). No additional adverse event (AE) was reported (no adverse event).
Vaccine schedule not followed, invalid dosing schedule.; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Vaccine schedule not followed, invalid dosing schedule.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Vaccine schedule not followed, invalid dosing schedule.). On 30-Nov-2021, EXTRA DOSE ADMINISTERED (Vaccine schedule not followed, invalid dosing schedule.) had resolved.      No relevant concomitant medications was reported. Treatment information was not provided.
Patient calls and says that the evening of vaccination, she wakes up with nausea and vomiting and very sensitive skin to the touch. General malaise and lack of energy continues through the next day. States she has bruise at injection sight.
lymph nodes, itchy joints, especially on wrists and fatigue; lymph nodes, itchy joints, especially on wrists and fatigue; big red circle; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (lymph nodes, itchy joints, especially on wrists and fatigue), FATIGUE (lymph nodes, itchy joints, especially on wrists and fatigue) and INJECTION SITE ERYTHEMA (big red circle) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     The patient's past medical history included Shingles in January 2021.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (lymph nodes, itchy joints, especially on wrists and fatigue), FATIGUE (lymph nodes, itchy joints, especially on wrists and fatigue) and INJECTION SITE ERYTHEMA (big red circle). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PRURITUS (lymph nodes, itchy joints, especially on wrists and fatigue), FATIGUE (lymph nodes, itchy joints, especially on wrists and fatigue) and INJECTION SITE ERYTHEMA (big red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Numbness, tingling sensation, decrease in movement at the upper arm and shoulder. Excruciating pain. No swelling at the injection site. Symptoms come and go for 7 days since 10/22/13. Per pt's wife, obtained anti-inflammatory med from primary MD.
Within 45 mins I started to get Hives on my palms, a rash on my arms the interior going up the arms, along my left side of my neck, my for head also had the rash. I was very itchy and scratchy. I began sweating profusely and drank more water.  I took benedryl to alleviate the symptoms. The next morning I awoke with a very bad headache, aches in my bones, pain in my chest, and in my lower right abdomen, as well as nausea and diarrhea.I had the normative tenderness at the injection site.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in 2007). On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the injection site pain and feeling unwell were recovered/resolved. It was unknown if the reporter considered the injection site pain and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced soreness at the injection site that started on the same day that she received the injection and lasted for a couple of days. The patient stated that she could not lie on her arm due to the soreness. The patient also did not feel well after receiving the vaccine, however, she was not sure when that started or how long it lasted. The patient was not sure if she would receive the 2nd dose.
Immunosuppressed patient received the booster instead of third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunosuppressed patient received the booster instead of third dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included METHOTREXATE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), FOLIC ACID, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunosuppressed patient received the booster instead of third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunosuppressed patient received the booster instead of third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had no acute and chronic illnesses at the time of vaccination. It was reported that the pharmacist wanted to know how to give the third dose of the Moderna COVID-19 vaccine to patient that received the booster of 0.25. There was no product complaint associated. No treatment medications were reported. It was reported that the patient never had COVID positive test or diagnosis.
Pt developed marked thrombocytopenia 4 weeks after receiving MMR, varivax, and Hep A.  Pt was given IVIG in emergency department on 7/17.
No side effects, adnistered wrong product, pt was due for her second covid dose and I administered the covid bivalent instead.
missed period for 4 months (always regular), and then had it for 2 days and missed another month and had it for 8 days and then had it again after 2 weeks
pt recvd vax 31MAR94 & was instructed to apply cool wet compresses to inject site if needed to reduce pain, redness or swelling; mom was instructed to give APAP for fever or pain; 430PM called said did not know how to measure the APAP;
Local reaction deltoid site of DTaP w/ erythema, induration 7x8cm.
pt recv vax 6NOV95 & 8 days later pt devel a morbilliform rash;pt recovered;no further details were provided;
Low-grade fever onset on 08/13/2015 (100-101 F). Fever increased to 103 F by early afternoon of 08/15/2015, spiked to 105-106 F that evening, and stayed in range of 103-105 into evening of 08/17/2015.  Fever meds (oral ibuprofen and acetominophen suppositories) were used to bring fever down during this time.  Child was taken to pediatrician on 08/17/2015.  Doctor did urine analysis and ordered stat bloodwork (comprehensive metabolic panel, LD, CBC panel with differential, and Sed Rate).  Bloodwork revealed high BUN/Creatinine (36.8), high CRP (15.4), slightly elevated monocytes (1080) and high Westergren Sed Rate (39).  All other results were normal.  Patient fever was 104 that night, ibuprofen was used to reduce to about normal.  As of PM on 08/18/2015, no signs of fever.  Child saw doctor on 08/18/2015 and doctor said to monitor for fever return or other unusual signs.
05/11/2021 presents to ED after a fall; recently admitted to another hospital for failure to thrive and multiple falls; hx of HTN, HLD, hypothyroidism, COPD, OA, anemia; D/C 05/13/2021 to HCF.
Patient received flu injection by per diem RN. Shot given high on lft shoulder and caused employee severe pain.
On days 1 and 2, I experienced normal symptoms from receiving the vaccine, fatigue, joint and head aches that lasted through the weekend and up to day 5. On day 5, I noticed unilateral lymphedema of my tonsils. On day 7, I went to an Urgent Care but didn't get much treatment. My condition worsened, I was fatigued, no appetite and thirsty. On day 8, I popped a fever of 103. On day 9, it worsened to the point that it was hard to breathe. I went to the ER on 10 and had a full array of tests. I was treated with dexamethasone and a bolus saline IV. My symptoms went away after treatment around day 14, but the lymphedema lingered for awhile longer.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 12 month old male patient who developed a 7 cm area of redness and 3 cm area of abscess. At 12 months of age, the patient received the fourth dose on 1/13/2006. The patient also received a dose of Haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate injection) manufacturer unknown, a dose of Varicella virus vaccine, love manufacturer unknown and a dose of Hepatitis B vaccine manufacturer unknown on 1/13/2006. Medical history reported as none. Indication for Prevnar was immunization. Product was administered on 1/13/2006, Dose regimen was 1 dose intramuscular. Additional suspect medication included varicella virus vaccine, live, administered on the same day an in the same thigh. The patient was not taking concomitant therapy. A physician reported that on 1/13/2006 the patient received a Prevnar and varicella vaccine in his left thigh (specific sties on the thigh were not noted). The next day the child developed a 3cm area of abscess (injection site abscess) and a 6 to 7 cm area of redness (injection site erythema) on his left thigh. The patient was treated in the ER with intravenous clindamycin and sent home on oral Bactrim (sulfamethoxazole Trimethoprim). All erythema resolved with 2 hours of returning home. The child was seen for a recheck on 1/16/2006. AT this time there was no fever, no tenderness and no warmth, touch was without discomfort. No other swellings or issues were reported, events pretty much resolved. Varicella reaction was doubted. An ell allergy test performed on 1/19/2006 was negative.
rash/ after 6 days she experienced a rash yesterday beginning in the nose then forehead, and cheeks; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 31Jan2021 (at the age of 74-years-old) as a single dose for an unspecified indication. Medical history included rheumatoid arthritis and autoimmune disorder. The patient's concomitant medications were not reported. On 06Feb2021, the patient experienced rash/ after 6 days she experienced a rash yesterday beginning in the nose then forehead, and cheeks. The caller is experiencing a rash after taking the first dose. Caller received Pfizer Covid-19 vaccine first shot on 31Jan2021 and after 6 days she experienced a rash yesterday beginning in the nose then forehead, and cheeks. There are also blisters in the face. Her next shot is on the 21st and wanting to know if she needs to continue the 2nd dose. Caller also had Rheumatoid arthritis and autoimmune disease. The patient did not receive any treatment for the events. The clinical outcome of rash/ after 6 days she experienced a rash yesterday beginning in the nose then forehead, and cheeks was unknown. No follow-up attempts are possible. Information about lot number has been requested.
Fast heart rate, anexity, shortness of breath, sore arm,  vomiting, chills, fever, muscle aches, migraine, shaking.  8:00AM to current but getting less severe 8:00PM .
3 weeks and 3 days after the vaccine, I experienced 2 days of intense menstrual cramping and moderate bleeding. Since I am on my 2nd Mirena IUD, I have had a Mirena for over 9 years, and this is the first time I have had any menstrual bleeding during that time.
RHEUMATOID ARTHRITIS FLARE UP; This spontaneous report received from a patient concerned a female of unspecified age and ethnicity. The patient's height, and weight were not reported. The patient has no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced rheumatoid arthritis flare up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rheumatoid arthritis flare up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210550994-covid-19 vaccine ad26.cov2-Rheumatoid arthritis. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS.
it was rpt from sales representative concerning pt p/recv vax subsequently devel fever 104d;
This spontaneous report was received from a registered nurse refers to a 14 year old female patient. The patient was not pregnant. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. On 06-JAN-2016, the patient was vaccinated with the first dose in the series of GARDASIL 9, lot # L016428, expiry date 30-JUL-2017, 0.5 ml, intramuscularly. On 06-JAN-2016 (also reported as same "evening"), the patient experienced a "sudden shaky feeling, nausea, stomach pain, and diarrhea". The nurse reported that the patient sought medical attention by calling another unspecified provider the next day on 07-JAN-2016. The nurse reported that the unspecified provider prescribed a treatment of "fluids and rest" on 07-JAN-2016. Lab diagnostics studies performed were reported as none. The outcome of the events was recovering (by the next day the patient felt better). The causality assessment was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.