chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/5/21 e week after the injection I noticed a lump at the injection site that was tender to the touch. It didn't go away and seemed to get flatter and was warm and tender over the weekend I iced it and took some Benadryl .At first it looked like it might be improving However, on 1/13/21  I woke up to a very large raised red area below the injection site that was very painful. I was advised by a healthcare professional to have it looked at since this had been going on so long and it was so far post shot. I saw an ARNP who diagnosed a cellulitis infection and had me take 10 days of Keflex which eventually resolved the issue.
Had bad chills and  bad aches and pains that kept me on the couch for about 6 hours, unable to function normally.  Not even able to watch tv
I have a blood clot in my left leg that is unprovoked /  The clot runs from poplioteal to common iliac.; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 12:00 (at the age of 38-years-old) as dose 2, single for covid-19 immunisation at pharmacy or drug Store. The patient medical history included none. Concomitant medications included lamotrigine (LAMICTAL), vortioxetine hydrobromide (TRINTELLIX). Other medications the patient received within 2 weeks of vaccination included Lamictal, Trintellix. The patient historical vaccine included first dose of BNT162B2 via route of administration, administered in left arm on 08Mar2021 05:00PM (at the age of 38-Years-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. It was reported that, on 21Jun2021 07:00 the patient had a blood clot in his left leg that is unprovoked and he had no underlying conditions. He is male and 38 years old. Blood tests haven't shown the underlying cause and I'm being seen by hemotoligists. The clot runs from poplioteal to common iliac. He was  having a thrombectomy on Monday. The patient was hospitalized for I have a blood clot in my left leg that is unprovoked/the clot runs from poplioteal to common iliac for 7 days. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, sars-cov-2 test: negative on 22Jun2021 (Nasal Swab).  Therapeutic measures were taken as a result of I have a blood clot in my left leg that is unprovoked/the clot runs from poplioteal to common iliac. Heparin was received as treatment for the adverse event. Will have to have a thrombectomy. The reporter assessed the seriousness as serious. Seriousness criteria caused hospitalization. The outcome of the event was reported as not resolved.  Information about batch/Lot number has been requested.
Soreness of the arm after the 1st dose; 12 year old patient got the 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of the arm after the 1st dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient got the 1st dose of Moderna COVID-19 vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the arm after the 1st dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient got the 1st dose of Moderna COVID-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Soreness of the arm after the 1st dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient got the 1st dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Symptoms of generalize body hives, itching and 5cm welt at injection site. Took OTC Benadryl. Reported to work 10/10/2013 and continued with same symptoms. Benadryl 50mg given IM by clinician at 8:15am. 8:45am staff member complained of shortness of breath. Staff member driven to Emergency Room and received IV fluids. Discharged to home same day. Hives remained for 4 days.
1 week after vaccination: left ear feeling of fullness and over all fatigue  left ear still full went to urgent care and said there was fluid. Prescribed steroids 20mg for 5 days. During course of steroids no change. Week 2: ear still full, noticing hearing loss in ear.  Goes to ent gets audio test and has noticeable hearing loss. Prescribed steroids 10days 40mg tapper.  Week 3-4 : steroids helped and obvious inner ear inflammation has gone down. Hearing test again hearing has come back.
Left shoulder pain after injection which I expected for a day or two. Left shoulder pain has persisted since 9/6/2017 which is almost 8 weeks. Decreased range of motion and pain on abduction, adduction, external rotation, forward flexion and extension.
In the morning following vaccination I felt severe weakness, my blood pressure showed 46/37 and I fainted, falling on the stone floor thus injuring hard my right knee, right arm, right shoulder and the right side of the face. Through that day my blood pressure stayed extremely low (65/41, 80/59) For shoulder pain that is lasting long, I have seen an orthopedic specialist. Since the fall, I have a TMJ that I am seeing doctors and having physical therapy for.
Pain in left upper arm radiating down length of left arm.  The following day had pain and swelling over left lateral chest and underarm.
Administered vaccine that was not stored in recommended teperature; A spontaneous report was received from a nurse concerning a 41-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # 025J20-2A. There were no reported AEs associated with this case of product storage error.
Gave a dose that was 9 days expired. The child is not experiencing any symptoms.; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 23-month-old female patient who received HAV (Havrix pediatric) (batch number ce74n, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2022, the patient received the 1st dose of Havrix pediatric (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 28-Jun-2022 Reporter's Comments: The reporter stated that a patient was administered a dose of Havrix in the left thigh, that was 9 days expired. The patient was not experiencing any symptoms at the time of reporting. The reporter consented to follow up.  Additional Supportive Information: The patient was administered dose of Havrix vaccine, which was already expired in 19th June 2022, which led to expired vaccine used.
Chills; Fever; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache). On 16-Apr-2021, CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.            Patient received the first dose on 19MAR2021 into her left arm having lot no 036A21A No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-370400 (Patient Link).
COVID arm. Swelling, heat, blotchy rash, itchiness, and pain at injection site
Syncopal episode. HR decreased 45, BP 90/54, SaO2 98% diaphoretic at discharge. HR - 72 - BP 108/64 SaO2 100% back to baseline < 30 min.
Information has been received from the registered  nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 24-SEP-2013 (lot number: H010915; exp date: 13-FEB-2015) No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
about 10 minutes after vaccine, patient became diaphorectic, clammy, nauseated, dizzy.
Patient order was to receive Moderna Bivalent dose Covid vaccine on 12/29/2022. The medical assistant administered 0.25 ml of the Moderna monovalent vaccine in error. The error was discovered on 12/30/2022 by a nurse checking documentation. The ordering physician and the patient were notified. The patient reported no adverse reaction other than the mild expected side effects of the Moderna vaccine. The patient was advised to return after 2 months to receive the Bivalent vaccine as recommended by the CDC in this instance. The error was documented, the Moderna monovalent vaccine was labeled with a bright orange label and moved to a different location in the freezer. Staff re-education was held with the administering.. ...MA, and all other MAs and nurses. A CDC "At A Glance" poster about the schedule and dosing of the Moderna Covid vaccines was placed on the wall in the vaccine room.
2 hour after injection pain subdeltoid.  over the next 3 week progressive pain in deltoid bursae are with lifting her left arm.  I saw the patient today 11/4/21 and started patient on physical therapy and warm compress and ibuprofen 400 mg + tylenol 500 mg every 8 hr as need for pain.  Patient appears to have a subdeltoid bursititis
Information has been received from a registered nurse concerning a 83 year old female with allergies to penicillin, codeine, erythromycin, and CELEBREX who on the morning of 18-SEP-2006 was vaccinated IM into the deltoid with a second dose of Pneumovax 23. Later that same day, the patient developed redness, itching, swelling and a sensation of heat in the arm where she received the vaccine. The area of involvement progressed down the arm overnight. On 20-SEP-2006, the patient contacted her physician's office. She was told to treat her symptoms with BENADRYL, ice and an unspecified steroid cream. On 21-SEP-2006, the patient reported that her symptoms improved, but did not completely recover. In 1999, the patient received a first dose of pneumococcal 23 and did have a reaction. Additional information has been requested.
Nausea, epgastric pain, tightness in neck and chest with breathing, chills and shaking Treatment: EpiPen 0.3 mg monitor vital signs
Rash on face and behind ears, with postules.; Face is slightly swollen; Rash on face and behind ears, with postules.; This is a spontaneous report from a contactable nurse (patient). A 16-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: En6198, expiration date was not reported) via intramuscular route, in right arm, on 18Feb2021 08:30 (at the age of 16-years-old), at dose 1, single for covid-19 immunization from doctors office/urgent care. Medical history included known allergy to bug bites. Concomitant medications included sertraline; l-methylfolate calcium (CALCIUM LEVOMEFOLATE); vitamin b complex (B-COMPLEX). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced rash on face and behind ears, with pustules and face is slightly swollen on 25Feb2021. No treatment was administered for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv tetanus APR97 pt then inadvertently recv another inj of tetanus 19MAY97;10 to 14 days later pt devel gen malaise, nausea & vomiting;pt was seen by MD who administered 1000ml of nl saline IV & phenergan IM;
Shivering, fever, whole body aches, headache, fatigue, nausea, loss of appetite , dizziness, pain in injected arm.
Pain from injection site on arm radiating down arm. Occasional numbness/tingling. Flexing arm and turning head to the left sometimes brings it on as does flexing arm. Throbbing. Max pain 8/10. Ibuprofen helps. Started same day or next day after shot and not improving. Continues 3 weeks out.
Aches, fever, chills, pain at injection site, loss of appetite, unable to sleep
This spontaneous report was received from a nurse via company representative referring to a patient of unknown who on an unknown date, was vaccinated with the third dose of GARDASIL. The nurse reported that the patient had received her third dose of GARDASIL 6 weeks early. No adverse experiences were reported. Additional information
Shortly after administering the vaccine patient complained of not being able to see, having a fever and experiencing pain that travelled down to her hip bones. She was given water and waited until her husband came to pick her up. Before she left she stated feeling a little better. Recommended the patient go to the emergency room.
Father brought child to Health Dept, 8/22/03 at 10am, This morning noticed child's right thigh "swollen, red, hot", was with childs grandmother evening of 8/21/03 till 8/22/03 7am when father got home from work.
Temp 101, chills, headache, injection site pain, body aches,fatigue, dizziness . Took Tylenol for 2 days.
I did not have a reaction to the vaccine. I tested positive for COVID-19 in 01/2023. I contacted my doctor and was prescribed PAXLOVID. I tolerated the medication without any complications. As of today, I feel better with no lingering symptoms.
Very distinct large red blotches about 5 inches long by 1 inch wide above the injection site. Also, a large rash with white bumps on  chest area  by shoulder. Additionally, a large brown spot on opposite shoulder  from injection.    Very sore  arm for 3 days unable to lift it .
Within 5min. of HPV vaccine the patient became dizzy and had syncope. She fell down and hit her head and right elbow on a table and chair respectively. We give her milk and she rested for 10 more minutes.
Information has been received from a physician concerning an 8 year old female who on 09/12/1996 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot#617223/562D) subcutaneously.  Concomitant therapy that day included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (616454/0382D) subcutaneously.  Subsequently on 03/24/2004, the patient developed chickenpox breakthrough.  The patient was seen with lesions and a sore throat.  The patient sought unspecified medication.  No medications were prescribed.  There was no product quality complaint involved.  The patient recovered. It was also reported by the physician that the practice had seen at least 10 cases of chickenpox breakthrough, all in children who were vaccinated in 1996 (WAES #0404USA00981).  Additional information has been requested.
I was had a total body ache I had hurt everywhere. I had headache and not a lot of congestion, but heaviness in my chest. Not the usual feeling I have with multiple sinus infections. One I tested positive I called my doctor to get on the antiviral. I was prescribed PAXLOVID. I did get the medicine the next day, there wasn't a lot of time to see more improvement. I felt better in a couple of days. I tested negative of the course of five days. About 10 days ago I have had symptoms of heaviness in my chest, a productive cough and cold symptoms. Basically, it's the cough that led me to go to urgent care on 04/10/2023. I was diagnosed with Bronchitis and placed on steroids to ease the inflammation. I have completed the medication; I cannot say I am feeling better.
Not feeling well; swollen lymph nodes felt like carrying golf balls under my arm; feelings of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), LYMPHADENOPATHY (swollen lymph nodes felt like carrying golf balls under my arm) and PAIN IN EXTREMITY (feelings of sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 009C21A and 044A21A) for COVID-19 vaccination.     Patient don't have allergies, no history of COVID.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), LYMPHADENOPATHY (swollen lymph nodes felt like carrying golf balls under my arm) and PAIN IN EXTREMITY (feelings of sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MALAISE (Not feeling well), LYMPHADENOPATHY (swollen lymph nodes felt like carrying golf balls under my arm) and PAIN IN EXTREMITY (feelings of sore arm) outcome was unknown.  No concomitant products were reported.  Reported that feelings of sore arm and not feeling well with other doses but did not specify which dose resulted in which side effects.   This case was linked to MOD-2022-541985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up contains no new information.
Patient stated rash started 10 days after injection.  The rash was red and 1 inch x 4-5 inches long.  It was 2-3 inches lower than the injection site and went around the arm.  It was slightly warm and not itchy and disappeared without any treatment 2-3 days later.
No additional AE; MMR vaccine that expired on Aug 18, 2022 was inadvertently administered to a patient on Aug 23, 2022.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 23-AUG-2022, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) at a dose  0.5 milliliter, lot #T027935, expiration date: 18-AUG-2022, as prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (lot # M017290, expiry date: 07-APR-2018). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 32.9 Fahrenheit (F) for 14 hours. No previous temperature excursion was reported. It was unspecified if the call was because of a data logger. No product quality complaint (PQC) was reported. Additional information has been requested.
Increasing mild to moderate local tenderness at the deltoid of the injection arm; This is a spontaneous report from a contactable physician. A 53-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) (lot# EH9899), via an unspecified route of administration in right deltoid, on 15Dec2020 at 07:45 AM, at single dose, for COVID-19 immunisation. Medical history included reactive airway disease, Blood pressure abnormal, kidney stones, no sense of taste or smell (Between Dec2019 and Jan2020 or Feb2020), migraine, ongoing obesity (250 to 255 pounds). Family history included migraine (family members). Previously the patient was immunized with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (booster) in Aug2020, varicella zoster vaccine rge (cho) (SHINGRIX) on 10Aug2020, influenza vaccine (unknown  manufacturer) on 12Oct2020, tetanus vaccine (unknown  manufacturer) and experienced mild arm soreness. Previously the patient received fluticasone propionate, salmeterol xinafoate (ADVAIR) from Dec2020 and experienced dry mouth and lost sense of taste. Concomitant medications included multivitamin (unknown manufacturer), fluticasone propionate, salmeterol xinafoate (ADVAIR DISKUS INHALER) from 2020 for reactive airway disease, allopurinol (unknown manufacturer) for kidney stones, atorvastatin (unknown manufacturer), potassium (unknown manufacturer); hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) for blood pressure abnormal, colecalciferol (VITAMIN D). The patient experienced increasing mild to moderate local tenderness at the deltoid of the injection arm on 15Dec2020 with outcome of recovered in Dec2020 (in 36 hours). On unspecified dates the patient underwent lab tests and procedures which included COVID-19 antibody test, COVID-19 PCR test, salivary test: all negative.
Just after 15 minutes-flushed face, itchy tongue and throat 1-6 hours-flushed face 7 hours-flushed face, itchy tongue, hives on torso, wheezing 18 hours-flu like symptoms 72 hours-hives on left arm and back Never any rashes or hives around injection site
Information has been received from a physician and a medical assistant concerning a 6 year old male patient who on 01/22/01 was vaccinated in the left arm with a 1st dose of Hepatitis A virus vaccine inactivated. There was no concomitant medications. On 01/22/01, the patient developed a 4 to 5 inch long and 2 to 3 inch wide area of redness at the site of the injection, the site was warm to touch, and the area was "pruritic". On 01/25/01, the patient returned to the physician's office. Additional details regarding the outcome of the patient's experiences were not reported. additional information is not expected.