chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 week after first dose, when I woke up, left arm at injection was itchy, red , very warm & swollen with a hard knot with large red fickle
fine rash on lower extremities below the knees with severe itching. 11/9/09:  Emergency Room records received for date of service 10/28/09.  Dx:  Allergic reaction. Assessment:  Presented to the ED with a rash/allergic reaction.  Treated with Depo Medrol IM.  Left AMA.
Fever at 102; Chills; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever at 102, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.   Fever at 102, Chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever at 102 was Not recovered/Not resolved.The outcome of event(s), chills was Not recovered/Not resolved.
Patient fainted after first dose of Moderna within  a few minutes. He was nervous to get vaccine and said he had fainted when getting blood taken before.
her arm is sore at the injection site; red near the injection site /The redness showed up today and its a pink color.; has a lump, and is red/ injection site lump; This is a spontaneous report from a contactable consumer or other non-HCP. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO184, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 23Jul2021 as dose 1, 0.3 ml single (at the age of 70-years-old) for COVID-19 immunization. Medical history included Kidney transplant in 1993 (takes rejection medication), COVID-19 from Nov2020, has had Covid in Nov and was in the hospital for a week, heart ablation twice (cardiac disorder), atrial fibrillation as the patient had Covid in Nov and was in the hospital for a week, which put her back into AFIB and she was treated with medicine and then normal again. Patient had earlier received flu vaccine as in 2016 the patient had a reaction to the flu vaccine, she was in the ICU for a week. Concomitant medications included cycloserine (50 mg twice a day; rejection pill) and prednisone (5 mg once a day) both taken on unspecified dates for unspecified indications. On an unspecified date the patient experienced her arm was sore at the injection site. On 24Jul2021 the patient had a lump, and was red and injection site lump. On 27Jul2021 the patient experienced red near the injection site and the redness showed up today and it was pink color, still tender. Vaccine Supplemental Form has been declined. The outcome of event her arm is sore at the injection site was unknown while outcome of rest all event was not recovered.  Follow-up attempts are completed. No further information is expected.
>24 hours after vaccine I had an extreme bout of vertigo that was very quick. While sitting at my desk working on the computer at 1:37pm, all of a sudden I felt like I was falling to the left while my desk/monitor felt like it was rotating up/around. I shouted, and it was over.  I felt mostly fine right after, but a bit foggy headed. So far this is the only instance.
VACCINE THAT WAS GIVEN WAS IN THE REFRIDGERATOR PAST THE 10 WEEK VIABILITY TIME
The patient came to pharmacy and asked to get the Covid-19 vaccine. He answered the pre-vaccination checklist for covid-19 vaccine form and stated this is his first time getting the vaccine. Pharmacist gave him Moderna Covid-19 vaccine on 06/24/2021. After the patient left, pharmacist entered his immunization record to  immunization registry and found that pt already received 2 doses of Pfizer(second dose:02/01/2021)  Patient was informed by pharmacist and he admitted that he did not tell pharmacist about his historical covid-19 vaccine because he lost his CDC immunization card. He is planning to travel and decided to revaccinate to get another CDC card Pharmacist apologized to the pt for the mistake of not checking the record before giving him the vaccine. pharmacist followed up with COVID-19 vaccine team for advise  about this case on 06/24/21 and was told to call the organization who gave him the vaccine to verify if this is the correct pt However, pharmacist could not contact them ( Facility is pt medical group and the doctor at facility only helped the pt to entered to registry when pt came for visit ; according to the pt he got the vaccine) Pt is doing fine, no side effect as of 06/27/2021 Pharmacist will reach out to COVID team 06/28/21 for further guidance
Redness left arm with minimal swelling and tenderness; size 85 X 78 mm; 0 fever
This spontaneous report as received from a medical assistant refers to a 19 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2016) and first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015, also reported as 12-FEB-2016) which were stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL and VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
A patch of Shingles on my back.  Evident blistering and pain in the rib cage area.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. Between 03-SEP-2017 and 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005796, expiration date 26-MAY-2018) (dose and route were not reported) for prophylaxis. The vaccine was exposed to 8.5 Celsius degrees (°C) for 1 hour. There was no previous temperature excursion and also there was no "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA009437: US-009507513-1709USA009443: US-009507513-1709USA009439: US-009507513-1709USA005606: US-009507513-1709USA009441: US-009507513-1709USA009442: US-009507513-1709USA009436: US-009507513-1709USA009435: US-009507513-1709USA009438.
Heart rate sustained above 140's.  Tachycardia for 2 and a half days.  Shortness of breath.
VACCINATION WAS ADMINISTERED LOWER THAN RECOMENDED IN BOTH ARMS DUE TO PT REFUSING TO PULL UP SWEATSHIRT TO ADMINISTER PROPERLY INTO DELTOID. PATIENT COMPLAINS OF BOTH ARMS HAVING PAIN ALL THE WAY DOWN INTO HIS ELBOW. HE SAID HE WAS VACCINATED IN HIS TENDON AND THATS WHY HE THINKS THE PAIN IS RADIATING DOWN HIS ARMS.
Headache, nasal congestion, productive cough, fever, chest congestion, wheezing, sneezing and itchy eyes starting 11/26/2021.
PT REPORTED DISCOMFORT OF LUE AND RN NOTED REDNESS AND MINIMAL SWELLING APPROX. 6"x3" BEGINNING APPROX. 1" BELOW INJECTION SITE AND EXTENDING TOWARDS ELBOW AND AROUND ARM POSTERIORLY.  ICE PACK WAS APPLIED TO SITE.
The pt experienced a fever of 101.3, treated with Tylenol. The pt also experienced a rash, which was red on the trunk and face. The pt was also fussy. The child was sick with a virus on 3/11 to 3/18.
Initial and follow up information has been received from a registered nurse concerning a 70 to 80 year old male patient who on 11-JUN-2008, was vaccinated IM with a 0.5ml dose of PNUEMOVAX 23 (Lot# 657145/1226U). On 11-JUN-2008 within 12 hours of the vaccination, the patient experienced an injection site reaction. The reaction was a red, raised area of 3 to 6 cm at the injection site, also described as a localized reaction. It was being treated with ice. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three reports from the same source. Additional information is not expected.
No additional AE reported; HCP reported an expired ROTATEQ was administered to a patient. She reported that ROTATEQ with an expiration date of 3/29/2022 was administered to a patient today (4/27/2022).; This spontaneous report was received from a nurse and refers to a 5-month-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not provided.  On 27-APR-2022, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter (ml), lot 1707496, expiration date reported as 29-MAR-2022 (strength, and route of administration were not provided) (expired vaccine used). No additional adverse event was reported.
Passed out, got very nauseous.  Was taken to emergency at hospital. This was day after shot administered.
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old male patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 24-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI995AA, expiry date 01 Apr 2018 via unknown route in the left deltoid. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
This spontaneous report was received from a physician and refers to a 3 month old female patient. The patient's pertinent medical history included feeding intolerance and reflux. The physician reported that the infant had feeding difficulties, reflux and diarrhea since birth. The patient had an allergy for bethanechol which caused bradycardia (onset date was not reported) and also the overdose for "bathanicole" was reported. The patient was diagnosed with E. coli sepsis at birth and kept in intensive care for 7 days. On 26-JUL-2017 (reported as 6 weeks ago and also therapy start date was reported as birth), the patient was vaccinated with a single dose of ROTATEQ, orally (lot # and expiration date were not reported). Concomitant therapy included omeprazole. On an unknown date in 2017, the infant's symptoms of ecoli sepsis, reflux, diarrhea and feeding problems progressed and on 06-SEP-2017 (reported as now), the patient was hospitalized. The physician stated that ROTATEQ was present in infant's stool from an unknown date in 2017. The patient had performed a barium swallow test (date unspecified in 2017) but the result was not reported. The patient's status at the time of the report was reported as recovering. The physician did not think that ROTATEQ had added to infant's medical difficulties. The physician assessed the infant status as life threatening. Upon internal review, the event of E. coli Sepsis was considered to be medically significant.
Covid-19 I tested positive for Covid-19 on February 10, 2023 I experienced a headache, cough, body aches, and chills, I was not taking and prescriptions at all.
Woke up at approximately 2 am with chills; Felt fine for about 6 hours, then had severe pain at injection site,; Full body weakness; Aches; Severe throbbing headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 13:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included minor high blood pressure and allergies to fish, mushroom and kiwi fruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), armodafinil (NUVIGIL) and curcuma longa (TURMERIC); all for unknown indication from an unknown date and unknown if ongoing. On 26Feb2021 at 20:00, the patient felt fine for about 6 hours, then had severe pain at injection site, full body weakness, aches, severe throbbing headache and on 27Feb2021 at 02:00 woke up with chills. Symptoms subsided about 16:00 the following day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe pain at injection site, full body weakness, aches, severe throbbing headache and chills were resolved on 27Feb2021 at about 16:00.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Tender and redness site of injection.  Right hip extremely painful .  Seems like muscle.  Limping.
Sore arm; Cold like symptoms; concerned he did not receive the full dose; felt some vaccine ran down his arm to the end of his elbow; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (concerned he did not receive the full dose), DEVICE CONNECTION ISSUE (felt some vaccine ran down his arm to the end of his elbow), VACCINATION SITE PAIN (Sore arm) and NASOPHARYNGITIS (Cold like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-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 06-Apr-2021, the patient experienced UNDERDOSE (concerned he did not receive the full dose) and DEVICE CONNECTION ISSUE (felt some vaccine ran down his arm to the end of his elbow). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and NASOPHARYNGITIS (Cold like symptoms). On 06-Apr-2021, UNDERDOSE (concerned he did not receive the full dose) and DEVICE CONNECTION ISSUE (felt some vaccine ran down his arm to the end of his elbow) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) and NASOPHARYNGITIS (Cold like symptoms) outcome was unknown. Not Provided          No concomitant medications were provided by reporter. Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on 26 Jun 2021 and contains significant information Additional events reported (Sore arm and cold like symptoms).
Systemic: Dizziness / Lightheadness-Medium, Systemic: hypoglycemia-Medium, Systemic: Nausea-Medium, Additional Details: Patient experienced low blood sugar/dizziness/nausea ~10 minutes after administration. Patient had not eaten at all during the day and immunization took place late afternoon. patient was given crackers and glucose tabs and monitored by intern pharmacist for ~15 minutes. patient recovered and called a friend for a ride.
Case number PHEH2014US019193 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 73 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014 he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. No adverse event was reported following this medication error (overdose).
"Painful spasms located on the lateral side of my left leg for approx. 20 -30 minutes", says patient. No treatment needed.
swollen lymph nodes in neck area, joint pain(severe at wrist),numbness to rt hand,red,raised patches on r fingertips, inability to sleep through the night, generalized achey sore muscles.
had sore; Dizziness; swollen glands in the neck and back of her head; Extreme fatigue; She had nausea; Rectal bleeding; had a hard time walking; she was stiff; Wheezing; was short of breath; felt a vibration inside her body; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary immunodeficiency syndrome (takes IGG replacement therapy) and Graves' disease (takes IGG replacement therapy).    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant), GAIT DISTURBANCE (had a hard time walking), MUSCULOSKELETAL STIFFNESS (she was stiff), WHEEZING (Wheezing), DYSPNOEA (was short of breath), FEELING ABNORMAL (felt a vibration inside her body), PAIN (had sore), DIZZINESS (Dizziness), LYMPHADENOPATHY (swollen glands in the neck and back of her head), FATIGUE (Extreme fatigue) and NAUSEA (She had nausea). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding), GAIT DISTURBANCE (had a hard time walking), MUSCULOSKELETAL STIFFNESS (she was stiff), WHEEZING (Wheezing), DYSPNOEA (was short of breath), FEELING ABNORMAL (felt a vibration inside her body), PAIN (had sore), DIZZINESS (Dizziness), LYMPHADENOPATHY (swollen glands in the neck and back of her head), FATIGUE (Extreme fatigue) and NAUSEA (She had nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After the first dose, the patient had extreme fatigue, rectal bleeding, had a hard time walking, she was stiff, had sore and swollen glands in the neck and back of her head. She had nausea, dizziness, wheezing, was short of breath and felt a vibration inside her body. This continued for 30 days after 1st shot and into 2nd shot. Mentioned that the patient has a pre-existing condition of primary immunodeficiency, autoimmune graves disease and for that patient was taking IGG replacement therapy. Concomitant medications were not reported. Treatment included steroids.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-255830 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
approximately midnight the day the patient received the vaccine she experienced: itching on the right side of her face, welts that lasted about 5 days.
patient got DVT a week after the first vaccine; This spontaneous case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (patient got DVT a week after the first vaccine) in a 74-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (patient got DVT a week after the first vaccine) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (patient got DVT a week after the first vaccine) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Patient took the flu vaccine with no problems on an unspecified date.  No treatment information was reported.  Company comment-This spontaneous case concerns an elderly male patient aged 74 years with no medical history reported, who experienced the unexpected serious (Medically significant) event of Deep vein thrombosis (AESI) about one week after first dose of mRNA-1273 vaccination in covid -19 vaccination series. He had received first and second dose of same vaccine on unknown dates. It was reported patient got DVT a week after the first vaccine. No further information on risk factors, medical history, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. Elderly age of the patient could be a risk factor to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-674656 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly male patient aged 74 years with no medical history reported, who experienced the unexpected serious (Medically significant) event of Deep vein thrombosis (AESI) about one week after first dose of mRNA-1273 vaccination in covid -19 vaccination series. He had received first and second dose of same vaccine on unknown dates. It was reported patient got DVT a week after the first vaccine. No further information on risk factors, medical history, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. Elderly age of the patient could be a risk factor to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.