chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe weakness; Nausea; Headache; Sore arm; Muscle pain; Joint pain; Fever; chills; Swollen lymph node in left arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no known allergies.  Concurrent medical conditions included Hypertension since 01-Jun-2012 and Depression since 01-Dec-2010. Concomitant products included CITALOPRAM from 01-Dec-2010 to an unknown date for Depression, IRBESARTAN from 01-Dec-2012 to an unknown date and HYDROCHLOROTHIAZIDE from 01-Dec-2012 to an unknown date for Hypertension.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021 at 1:30 PM, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm) and HEADACHE (Headache). On 20-Jan-2021 at 6:00 PM, the patient experienced ASTHENIA (Severe weakness) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jan-2021 for Fever, at a dose of UNK dosage form (2) at 8 PM; IBUPROFEN on 20-Jan-2021 for Headache, at a dose of 200 mg twice a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Jan-2021 for Adverse event, at a dose of UNK dosage form. On 21-Jan-2021, ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm) and NAUSEA (Nausea) had resolved. On 22-Jan-2021, MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 101.8f (High) 101.8F and 100 (High) 100 at 4-5 when she took Ibuprofen tablets. On 20-Jan-2021, Heart rate: 130 bpm (High) 130 bpm. On 21-Jan-2021, Body temperature: 102.7f (High) 102.7F. On 21-Jan-2021, Heart rate: 110 bpm (High) 110 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm), NAUSEA (Nausea) and HEADACHE (Headache) to be possibly related.    It was reported that the adverse events were likely caused by mRNA-1273. There were no other potential causes.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter details and concomitant drugs were added, outcome for the events with stop dates updated
Six days after vaccine administration he presented with widespread urticaria rash.  Of note he also finished a course of Bactrim the day before rash started
Got my menstrual period on day 19 of cycle -- really early. Typically cycle is between 26-28 days.
Patient was fully vaccinated for COVID (dose 1 = 2/22/21, dose 2 = 3/15/21), but was hospitalized on 10/15/21 with COVID and is in acute resp. failure.
pt recv vax 30OCT95 & devel a sl lump @ the inj site;pt also devel a papular rash (flush colored papules) on injected thigh;no further details known as of reporting date
SEEN ON 4/16/2021 WITH PROVIDER  WITH THE FOLLOWING COMPLAINTS: Pt here for left sided low back pain; he gets it in different spots. Sharp - left mid back , left low back, left hip and left thigh. Does not radiate to foot. Does not cause paraesthesias, numbness, weakness or tingling. No problems urinating, dysuria. The pain started after janssen vaccine along with low grade fever; lasted for 2 days then went away for over 1 week. In fact he drove and hiked 10 miles as well w/o any recurrence of pain. He notes pain restarted 2 days ago. Massage and heat help. Exercising does not worsen. Pain for past 2 days is at a 2 level. No hx of back pain or arthritis. He does have hx of renal stones and cystitis but was cleared last year by his urologist. He has not drunk enough water today and would like to do his cbc on 4/22. He denies any heaches, vision changes, abd pain or leg pain. Most of the time his pain is low back area. It was more intense in the 2 days after vaccine. No hx of blood clots. No chest pain or SOB. No injuries to back. Pain is the same as post vaccine though milder. He denies straining his muscle. No easy bruising or bleeding. kidney stones feel much differently.
I felt very tired, chills, body aches, head ache, congestion , mild fever
Vaccine Pfizer, 2nd dose, R arm, lot # EW0171.  Patient looked unstable walking, reported feeling dizzy.  They laid her down on a cot. Vitals: 1515: HR 71, BP 102/62, resp 14, O2 100% room air; 1520 - HR 77, BP 98/60, resp 12, O2 100% room air; 1525: HR 77, bp 100/64; resp 14, 100% room air; 1530: HR 73, bp 98/66, resp 14, O2 98% room air.  After last vitals she reported feeling much better,
Red, painful, soreness around injection site. Appeared 5 days after first injection and 2 days after section injection. It is not itchy but it leaves my arm very red and sore
A physician reported via manufacturer the occurrence of a decreased therapeutic response in a 55 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's relevant medical history, concurrent conditions, and concurrent medications were not reported.  The reporting physician stated that on 12/23/01, the subject was exposed to "blood borne pathogens and received a three-injection series of Engerix-B vaccine.  On 10/30/02, his titer (NOS) was less than 2."
Chills, low grade fever, fatigue, headache All started approx 4:30am on 3/12.  All were resolved by 6:30 am 3/13.  Advil and Alleve used to treat.
Pt was given 0.5 mL of Moderna Bivalent instead of correct dose of 0.25 ml  12-9-22, called and spoke with patient mom, patient mom reported pain at injection site and patient was tired/sleppt all evening last night.  -Denies symptoms of fever, dizziness, headaches, cough, shortness of breath, or fatigue today.   Patient mom reports he is doing ok.
Lot was expired BUD on 03-14-23 this was the ten week date past deep freeze by the state. 3 days past. Patient received injection by MA and Practice Manager noted this on check of vaccine logs. Patient was called and Pfizer is being notified as well as ISMP. Will relay recommendations to patient. No adverse effects reported by patient.
This case was reported by a nurse and described a 54 year old male subject who did not respond to immunization with hepatitis B vaccine recombinant Engerix B for prophylaxis. The subjects medical history included hypertension, asthma and social alcohol consumption. On 11/10/2004 the subject received 1st dose of Engerix B. On 12/10/2005, the subject received 2nd dose of Engerix B. On 6/8/2005, the subject received 3rd dose of Engerix B (lot AHBVB125AA). The represents an interval of seven months between the 1st and 3rd doses of Engerix B which is longer than the recommended interval of six months between the 1st and 3rd doses. On 08/24/2005, 77 days after vaccination with the 3rd dose of Engerix B, a hepatitis B surface antibody titer was negative. The nurse considered the negative antibody titer to possibly be related to vaccination with Engerix B.
pt recvd vax 14DEC94 & had apneic episode turned pale & sl blue color & was unresponsive EMS called taken to ER evaluated 1915 pt was alert, vigorous, crying loudly during attempt to start IV; has done well since transfer to another hosp;
VERY HIGH FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced very high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very high fever was not reported. This report was non-serious.
Information has been received from a Nurse Practitioner concerning a 17 year old female with a history of neuro- surgery in 2001 for malformation and laparoscopic surgery on left ovary for cyst who on 22-JUL-2009 was vaccinated with a first dose of GARDASIL (lot # not reported) 0.5ml, intramuscularly. There was no concomitant medication. On 22-JUL-2009 after vaccination the patient experienced syncope. Afterwards for 1-2 minutes, the patient experienced what appeared to be a seizure. The symptoms include tightening and straightening of the body with heavy breathing. An ammonia capsule was used. Also, it was mentioned that the patient vomited at home. In the afternoon, the patient was oriented and recovered. The mother of the patient mentioned that the patient had had previous experiences with seizures: First time occurred at the age of 10 years (unspecified cause), second occurrence happened at 14 years of age (unspecified cause) and the third time occurred in December 2008 when the patient had her bellybutton pierced. There were no laboratories diagnostics studies performed. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Itching has gotten worse/tips of her ears felt inflamed and were itchy/The itching was so unbearable at times it waked her up at night from sleep; Hives; Bumpiness; Redness; Tips of ears inflamed and are itchy; I have bruised myself from itching my arms; This is a spontaneous report from a contactable other health care professional (patient) reported for herself. A 27-year-old non-pregnant female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27Mar2021 17:00 (at the age of 27 years old) (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Medical history included known allergies as Penicillin-related antibiotics. Concomitant medications within 2 weeks of vaccination included colecalciferol (VIT D3) and cyanocobalamin (VIT B12). The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 12:00 PM (at the age of 27 years old) (Batch/Lot Number: EN6202) as single dose for covid-19 immunization and experienced Itchy arms, red dots, Itching on arms progressively got worse, petechiae. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. 1-2 weeks after first dose, started having itchy arms - didn't think much of it because it would go away. Around the same time, red dots started forming around her ankles up to her lower thighs - not raised or itchy. Itching on arms progressively got worse. Went to the doctor and she attributed it to the vaccine. Rx'd Triamcinolone Cream and checked platelets for possible petechiae on her legs - platelets were normal. Said it was ok for her to get second dose. Itching had gotten worse. Itching leads to hives, bumpiness, and redness. Had spread from arms to legs to torso over last few weeks. At time of report, the tips of her ears felt inflamed and were itchy. The only thing that had somewhat helped was diphenhydramine hydrochloride (BENADRYL). Creams/lotions did not help. The red dots were still present, but more local to her ankles. The itching was so unbearable at times it waked her up at night from sleep. The patient bruised herself from itching her arms. Date of start of reaction/events was Mar2021. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included platelet count: normal in Mar2021, covid test (Spit test): negative on 30Mar2021 (Nasal Swab). The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021367775 same  patient/reporter, different AE/dose
Patient counseled on vaccine to sit and wait at least 5-10 min after vaccine administered. Patient left right after administration. Patient found at exit window of office. At time of arrival to patient, patient awake and oriented but feeling light headed and hot. Skin also note to be pale. Grandmother and 2 staff members next to patient. Staff member states "she fell here at the check out window and hit head on the counter and then fell against the wall. She was unresponsive for approx. 15 sec." Patient moved to nearest exam room and assessed. Patient talking and responding appropriately. BP assessed at 1515 to be 70/44. Physician in room assessing patient. BP rechecked at 1520 to be 80/50. Advised to call if any change in condition.
Leg and arm pain first two to three days, which transitioned to pins and needles sensation and a feeling of numbness across both arms/hands, legs/feet and tingling of face/cheeks. Sensation of numbness was most pronounced in my hands. There was also intermittent chest pain. I sought medical attention as soon as possible once the numbness started occurring (within a week of the shot). About two to three weeks after the shot I also experienced headaches in addition to the other symptoms. After that, the symptoms began to go away.  My doctor ran blood tests and an EKG, etc. Nothing abnormal showed on those tests aside from low B12 levels. I had a follow up appointment with doctor the first week in November 2021, about a month after the first vaccine dose. At this point, the side effects seem to have gone away for the most part.
Dose Number : 3; Severe chills; body ache; mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Dec2021 (Lot number: 3302680) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 27Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 12Apr2021, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "unknown", described as "Dose Number : 3"; CHILLS (non-serious) with onset 04Dec2021, outcome "recovering", described as "Severe chills"; PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "body ache"; PYREXIA (non-serious) with onset 04Dec2021, outcome "recovering", described as "mild fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pain, pyrexia.  Additional information: The patient experienced Severe chills, body ache and mild fever the night of the vaccination and the day after. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse concerning a female pt who in October 1999 was vaccinated with varicella virus vaccine. The registered nurse reported that the pt subsequently "got chicken pox twice." Subsequently the pt presented with "non-specific dermatitis, possible bug bites. Multiple erythematous papular areas on the forehead." The pt presented on 04/06/2001 with a "papular, non-vesicular, non-pruritic rash on the torso and extremities." The pt's outcome was not reported. The registered nurse also reported on the pt's sibling who had an experience following the vaccination with varicella virus vaccine and on an unspecified number of children who developed chicken pox following vaccination with varicella vaccine. Additional info has been requested.
The pt experienced chills and the left upper leg was swollen with red area and lump about 20 mm and red patchy areas around lump. The child complained of pain with touch. Treated with Antibiotic Augmentin.
PT'S INJECTION SITE BECAME RED, SWOLLEN, AND PAINFUL. REDNESS MEASURED ABOUT 30MM.
Patient had erythema, edema, warmth extending throughout her entire deltoid muscle on her right upper arm where the injection site had occurred. Per patient this started around 3 hours after injection.
Less than a week after my second dose, I started itching on my body. Where I scratched, hives would show up (I have a lot of pictures for proof if needed). Hives were painful, itchy, and consistent. I called a Teledoc and also went to Urgent Care. They prescribed me an anti-viral, antihistimines, steroid pills, and steroid topical creams. Nothing helped.  I bought oatmeal lotions and oatmeal bath, but sitting in the bath irritated and inflamed my back even more. The only thing that relieved the itching and pain, was making a paste out of the oatmeal bath powder, and covering my body. That being said, I had to take off of work for the week due to the uncontrollable pain and itching. Being at home, I basically just laid in bed covered in paste. But laying in the bed for too long also inflamed my back and caused pain. The symptoms started decreasing in severity. I started using herbal topical oils instead of the paste, when I could. I had two: one with the following ingredients: Menthol 14.5%, Methyl Salicylate 30%, Inactive Ingredients: Chlorophyll, ethyl alcohol, mineral oil, rose oil. The other: Menthol, Peppermint oil, Camphor, clove oil, and cinnamon oil . Those relieved my symptoms as well. I went to see a dermatologist 5/5 since the symptoms persisted. She prescribed Xyzal, Zyrtec, and more Prednisone. Said to come back in a month if symptoms still persisted. Went back yesterday (6/9) since I am still having symptoms and she diagnosed me with chronic urticaria. My symptoms have decreased in severity in comparison to when it first started. Now (two months after my second vaccine), I still get hives when I apply too much pressure to my skin ("too much" meaning things like: putting on or taking off my watch, hanging my purse on my right arm, accidentally rubbing my arm against a desk,  accidentally grazing my coffee table with my leg, etc.) At least my body isn't itchy, causing me to scratch like when it first started. But I am still having symptoms and a reation.
Felt hot and diaphoric, felt faint amd nauseous.  Did not faint.
2 inch red, raised, irritated area on left arm and generalized joint discomfort first noticed on 06/20/02. Joint discomfort not affecting activities, 06/24/02 discomfort much better, no new complaints.
felt almost like fainting; felt like she was drowning especially when going to sleep; chest tightness/felt tightness in her chest; She couldn't take a deep breath.; This is a spontaneous report from a contactable physician. A 39-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient received the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and experienced chest tightness. Patient started to experience this symptom the day after she got the 1st dose - Experiencing chest tightness/feeling of drowning especially when laying down to bed daily - No history of cough, fever, anxiety, depression. The patient got the shot during the first 10 to 15 minutes she felt almost like fainting, but she didn't. Patient was keep for 15 to 20 minutes after receiving the vaccine to monitor. The feeling didn't last long. The first ten days after the vaccine the patient felt tightness in her chest for no reason. In the patient's medical history, there is no history of asthma or reactive airway disease or anxiety or depression. For a total of 10 days the patient felt like she was drowning especially when going to sleep. She couldn't take a deep breath. She didn't have to seek medical attention or go to the ER. The outcome of events was unknown.  Information on lot number/batch number has been requested.
24 hrs later, hoarseness... not present next morning but started again at 48 hrs
smelling smoke; burning eyes; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PAROSMIA (smelling smoke) and EYE IRRITATION (burning eyes) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2CA) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 12-Feb-2021, the patient experienced PAROSMIA (smelling smoke) and EYE IRRITATION (burning eyes). On 07-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 13-Feb-2021, PAROSMIA (smelling smoke) and EYE IRRITATION (burning eyes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details include eye drops.
no adverse effect reported; the patient received improperly stored VARIVAX; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant, and the following information was provided. The patient was a one year old female. On 27-NOV-2018, she was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA012348: US-009507513-1908USA012358: US-009507513-1908USA012365: US-009507513-1908USA012374: US-009507513-1908USA012377: