chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; Headache; Body ache; A spontaneous report was received from a consumer concerning a 22-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, headache, body ache (myalgia)   No medical history was provided. No concomitant medications were provided.   On 09-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 036A21A), intramuscularly in right arm for prophylaxis of COVID-19 infection.   On 10-Mar-2021, the patient experienced fever, chills, body ache and headache. The patient was concerned when his symptoms would be over.  The treatment medication included ibuprofen.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events fever, chills, headache, bodyache (myalgia) were considered unresolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K010221, expiration date 12-MAY-2016 (strength, dose, route of administration and indication were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms started at 11:00PM -  headache, chills, muscle aches, fever, soreness at injection site/unable to use right arm due to intense pain, nausea, joint soreness.  All ran to ~9:00PM Saturday, April 3.   Rash/hives subsequently began Sunday AM, April 4 and continues albeit lessens by the day.
I found out that client received the Children d Pfizer vaccine instead of the adult.  I realized this when she returned for the second dose  I told they parents that she will be given the pfizer purple cap vaccine for the second dose based on the CDC recommendations.
Two days after second shot, I began experiencing pain in my chest, especially sharp when cough, sneeze or hiccup.  I went to see Dr. on March 10 and he diagnosed as a recurrent pericarditis.  I had a case approximately 2 years earlier.  He said it would take longer for it to go away this time.  I've been under his care ever since, and the pain has never subsided.  I am now in an extended timeframe of having the pain and do not believe it to be a coincidence.
Client was seated upon exam table and received all four vaccines with no complaint. About 5-7 minutes later, client expressed that he felt like he was going to faint. Both RN and client's mother moved toward the client as he seemingly lost consciousness and drifted to the right in a seated position toward his mother. Client's mother and RN supported the client and helped to lay him flat on the exam table with his feet elevated. At this time the client regained consciousness and stated he was feeling better, also asking for something to eat. Client RR and HR WNL. RN applied cool cloth to client's head and provided him with food and water. Client continued to lay flat for about 10-15 minutes and recovered appropriately.
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, frequency, route and lot # were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
The baby displayed significant lethargy and about an hour later vomited an unusually large amount. At that time she had a fever of 101 degrees F. She slept and nursed on and off for the next few hours. The fever appeared to have dissipated by 3am on 10/18/2013.
Patient experienced mild body aches approximately 6 hours after administration. Patient then experienced fever, up to 101.5F accompanied by rigors, fatigue and more pronounced body aches approximately 8 hours after vaccine administration. Fever decreased to 100F then back to 101F over a period of approximately 10 hours. Patient was given acetaminophen 1000mg x 2 over the next 12 hours. Fever was resolved within 24 hours of vaccine administration. Fatigue and muscle aches lasted approximately 2 days after vaccination.
Information has been received from a physician concerning a 12 month old male described as healthy who on 4/2/05 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination that day included a dose of MMR. On about 4/15/05, the patient developed bilateral conjunctivitis, was seen in the emergency and was given antibiotics and ibuprofen. Fifty minutes after being given the ibuprofen, the patient developed vasculitis and purpura plaques. A later skin biopsy arrived at the diagnosis. The vasculitis was on the patient's face, buttocks, thighs, and feet. The patient also had a fever as high as 102 F. On 4/18/05, the patient was admitted to hospital. It was reported that while hospitalized the patient was administered VZIG and had a spinal tap that was clean. At the time of the report, the patient had not recovered. Additional information has been requested.
Information has been received from a consumer concerning her daughter a 16 year old female with exercise induced asthma and no drug reactions/allergies who on unspecified dates were vaccinated with all three doses of GARDASIL. Concomitant medication reported as PROHALER. The patient experienced pain at the injection site when she received all three of her GARDASIL injections. There was no lab diagnostics studies performed. The pain was only during the injections and occurred in the physician's office and did not persist. This is one of the cases reported from same source. Follow-up information has been received from a health professional concerning the 16 year old female who on 21-MAY-2010 was vaccinated at left arm with the second dose of GARDASIL (LOT# 666121/1778Y). The health professional stated that the patient on 21-MAY-2010 experienced painful injection. No further information is available at this time of reporting. Follow-up information has been received from the patient's mother who reported that the patient complained of pain at the injection site after injection was given. There was no lab diagnostics studies performed, no illness at time of vaccination. No further information is available.
5" x 3" indurated, red, hot and itchy firmness in left arm - site of injection. Fatigue and nausea 9/23/14.
Have been battling CHRONIC hives since 1st Pfizer Covid booster.  4 Zyrtec per day has helped suppress this, but still have incidents of itchy hives that appear to be heat/pressure induced.  Early on I used OTC cortisone.  Eased itching, but did NOT eliminate hives.  After seeing dermatologist used Halobetasol Propionate Cream 0.05 % which eliminated itch and hives, but did not prevent additional hives from occurring.  Used Prednisone prescription when hives began appearing after the bi-valent vaccine.  Hives temporarily eliminated, but have returned, occurring sporadically, despit.  Had NO such problems until having the Pfizer Covid vaccine.  Am completely convinced this now chronic condition was caused by vaccine/vaccine booster ingredient.
This spontaneous report as received from a nurse practitioner refers to a 9 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt came in complaining of knot on left leg at injection site, hard, red and swollen.
Felt cold for 3 days, redness at area, knot about the size of a silver dollar at injection site.
Headache, Arthralgia, chills, pain and redness at the injection site. Narrative:   Other Relevant History:
No adverse event; Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.3mL dose of the Moderna COVID-19 vaccine BIVALENT by intramuscular injection instead of the recommended 0.5mL dose).    Concomitant drugs were not reported.  It was reported that administrations occurred over the course of approximately 1 month. Patient had no reported symptoms, no additional doses or treatments.   This case was linked to US-MODERNATX, INC.-MOD-2022-682550, US-MODERNATX, INC.-MOD-2022-682547, US-MODERNATX, INC.-MOD-2022-682544 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682550:same reporter US-MODERNATX, INC.-MOD-2022-682544:same reporter US-MODERNATX, INC.-MOD-2022-682547:same reporter
This case was reported by a physician, via a sales representative, and described the occurrence of cellulitis of the left thigh in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). On 9 July 2012 the subject received a dose of KINRIX (unknown route), 2nd dose of varicella virus vaccine (Non-GSK) (unknown). In 2012, less than one month after vaccination with KINRIX and varicella virus vaccine (Non-GSK), the subject experienced cellulitis of the left thigh. The site of injection was not known at the time of the report. This case was assessed as medically serious by GSK. In 2012, the event was resolved. The physician considered the event was probably related to vaccination with KINRIX and Varicella virus vaccine (Non-GSK). The physician reported another case with KINRIX via a sales representative. See A0990329A for details on the other case. The vaccine was received through vaccines for children. According to the sales representative, the physician had already reported both cases to VAERS.
On the day of the second vaccine I got, I had a sever side effect with fever, chills, weakness. I am still having those symptoms as I am reporting this
Expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022 at 11:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Jan-2022 at 11:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported. Reporter stated that Moderna vaccine pulled from freezer 16 Dec 2021, BUD date of 15 Jan 2022 printed in red and taped to the top of the boxes. On 26 Jan 2022, staff brought it to attention that it was still in the fridge and expired and 5 doses had been given. On 31 Jan 2022, responded that revaccination was not required. No treatment information details were reported.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event. No treatment medications were provided.
Fever ,  chills , left arm pain that continued until 2nd vaccaine. after 2nd vaccine shortness of breath, sore thoart , hoarse, bone pain muscle pain nausea
Sore right shoulder pain that radiates down to fingers; arm is weak. Right side of neck is painfully stiff, pain radiates to top right side of head causing headache. Right ear sounds buffered, depending on head pain.
mild diarrhoea; sore under injection site; pregnant during first dose; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of DIARRHOEA (mild diarrhoea), VACCINATION SITE PAIN (sore under injection site) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant during first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B2A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 26-May-2021. On 13-Apr-2021, the patient experienced DIARRHOEA (mild diarrhoea) and MATERNAL EXPOSURE DURING PREGNANCY (pregnant during first dose). 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore under injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 13-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant during first dose) had resolved. At the time of the report, DIARRHOEA (mild diarrhoea) and VACCINATION SITE PAIN (sore under injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2020, Pregnancy test: positive (Positive) positive.     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.   Treatment medication not reported.  Estimated conception date was 02 Sep 2020.
Moderna COVID-19 Vaccine EUA    I'd like to report an unexpected side effect of the Moderna COVID-19 Vaccine.   Other than the arm ache/& pain and generalized flu like symptoms for a few days after the injection, these symptoms occurred at the fourth-to-fifth day after the second dose of the Moderna COVID-19 vaccine, and they lasted for about a week.    1. Left arm, dime-size, itchy, raised, red rash at the site of the injection,  2. Left upper arm, inner aspect, blotchy-itchy-raised-red rash, and  3. Generalized itchy papule rash on my back, which lasted more than a week.
Patient is currently breastfeeding; sore arm; swollen underarm in the lymphatic glad area; injection site is very tender and painful; injection site very warm; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is currently breastfeeding), VACCINATION SITE WARMTH (injection site is very warm), MYALGIA (sore arm), VACCINATION SITE PAIN (injection site is very tender and painful) and LYMPHADENOPATHY (swollen underarm in the lymphatic glad area) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.  No medical history was reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is currently breastfeeding) and MYALGIA (sore arm). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site is very warm), VACCINATION SITE PAIN (injection site is very tender and painful) and LYMPHADENOPATHY (swollen underarm in the lymphatic glad area). On 16-Mar-2021, MYALGIA (sore arm) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is currently breastfeeding), VACCINATION SITE WARMTH (injection site is very warm), VACCINATION SITE PAIN (injection site is very tender and painful) and LYMPHADENOPATHY (swollen underarm in the lymphatic glad area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Additional information was received from the initial reporter: New events Myalgia, vaccination site pain, vaccination site warmth and Lymphadenopathy were added
Headache; left arm sore from injection; Got a little tired; Crappy; This is a spontaneous report from Pfizer sponsored program Xelsource. A contactable consumer (patient) reported that, A 49-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733, Expiry Date: 30Jun2021), via unspecified route of administration on 30Mar2021 (at the age of 49 Years) as a 2nd dose single for COVID-19 immunization (did not want Covid, as reported). Patient had medical history diagnosed in 2004 with Rheumatoid arthritis, Upper Respiratory infections both on unspecified dates and huge bruises on her legs, everything black and blue in Jan2014 which was resolved. Patient reported that, her rheumatoid arthritis and having to work a 60 hour week causes her to be tired. For Rheumatoid Arthritis, Patient had a temporary stop on Methotrexate (Tablet) in 2008-2010 due to being in remission which has started in 2004 (Unknown dosage oral once a week), which she took for a 9 month window (Dosage permanently discontinued), adverse event improved as a result of it. and resulted in the Upper Respiratory infections (on unknown date) and Enbrel in 2004 (Unknown dosage injection weekly) which caused, huge bruises on her legs, everything black and blue (on unknown date) which has been permanently discontinued in 2004. Patient switched from Enbrel to Humira in 2004-2005 and she recovered completely from being switched. Patient also reported that, she permanently stopped on Methotrexate injections a couple of years before (NDC, lot number and expiration: Unknown). Reporter seriousness for stopped to taking Methotrexate and Enbrel and all the historical events were Unspecified. Patient's concomitant medication included, Xeljanz XR 11mg for Rheumatoid arthritis and informed it has been working really well for her and has had no flare ups. He did not received any other product. Patient had first dose of historical vaccine BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206, Expiry date: 30Jun2021), via an unspecified route of administration on left arm on 08Mar2021 (at the age of 49 Years) as a 1st dose single for COVID-19 immunization. After 1st dose of vaccine on 08Mar2021patient experienced, headache which was recovered on 09 Mar2021 and left arm sore from injection recovered on 11Mar2021. Patient Stated that on 30Mar2021, she took the Covid vaccine and got a little tired and it caused her to be in the bed for a little while and crappy and after a day or so she was fine. She also experienced headache and left arm sore from the injection on the same day (30Mar2021). Patient had Blood test, stated that she gets bloodwork often (dates and results unspecified). Patient received Over the counter Tylenol as a treatment for events. Outcome of the left arm sore from injection was recovered on 02Apr2021 and rest of the events were resolved on 31Mar2021.  No follow-up attempts are required; information about lot/batch number already obtained.