chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some achyness; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (some achyness), FATIGUE (fatigue) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020 and Hair loss in December 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, LISINOPRIL for Blood pressure high, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ESCITALOPRAM OXALATE (LEXAPRO), COLECALCIFEROL (VITAMIN D 3) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (some achyness), FATIGUE (fatigue) and HEADACHE (Headache). On 07-Mar-2021, MYALGIA (some achyness), FATIGUE (fatigue) and HEADACHE (Headache) had resolved.        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.   The patient reported that back in September 2020, was very ill and dehydrated and went to the hospital a couple of times,  but every once in a while starts feeling funny, strange, very fatigued, feels kind of like a shortness of breath and a heaviness on her chest, it comes out of nowhere. Treatment medication included Tylenol.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 23-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M042503 for prophylaxis (expiration date: 18-AUG-2017). Concomitant therapies included sterile diluent lot # L006552 (expiration date: 12-NOV-2017). No adverse effects reported.
inflammation of back muscles, mass near breast, Lidocaine patches at home for weeks Many tests in ER at Hospital Do not have their report
feels off; nauseaus; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient in her 40's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 15Oct2022, outcome "unknown", described as "feels off"; NAUSEA (non-serious) with onset 15Oct2022, outcome "unknown", described as "nauseaus".  Additional information: The patient's age was reported as mid 40's.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I experienced at time of vaccine couple of hours later, my neck and  my head was burning. I never experienced this. I felt I was no functioning properly. I could not feel my touch and hold a pencil. I also really hot but did not have any fever. I had a severe headache and I did not have a fever. My son was called to pick me up at work. I had trouble speaking and slurred speech and my coordination was slow. I also had a seizure episode and was taken by ambulance to the ER . I also felt very confused and delayed in response. I had exams done and everything came back to normal. I also had a blood clot on the back of my left leg. I also had hand pain and saw my physician.  After 48 hours I was fine.
PATIENT PRESENTED WITH WATERY, BURNING LEFT EYE AND PATIENT WAS ADVISED TO SEE HER PCP. PATIENT SAW PCP ON 10-29-09 WITH PARALYSIS OF LEFT EYE AND LEFT SIDE OF FACE AND MOUTH. PHYSICIAN DIAGNOSED BELL'S PALSY AND TREATED PATIENT WITH VALTREX AND MEDROL DOSE PACK. 12/7/09 Medical records received for date 10/29/09. DX: Bells palsy Chief c/o left side face numb, left eye watery x2days. Pt developed poor eyelid closure, asymmetric smile x48hrs. OV 11/17/09 f/u bells palsy. 85% resolved today.
A very large lump in her left arm pit from her pec to her breast; Chills; Body aches; Horrible headache; This spontaneous case was reported by a health care professional and describes the occurrence of AXILLARY MASS (A very large lump in her left arm pit from her pec to her breast), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Horrible headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced AXILLARY MASS (A very large lump in her left arm pit from her pec to her breast), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Horrible headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, AXILLARY MASS (A very large lump in her left arm pit from her pec to her breast), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Horrible headache) outcome was unknown.        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.   No relevant concomitant medications were reported.
This spontaneous report was received from a nurse and refers to a 76 years old male patient with sleep apnoea. The patient's medical history included pneumonia on an unknown date in 1960. The patient had no concomitant medications and no known drug reactions or allergies. On 10-OCT-2018, the patient was vaccinated with injection PNEUMOVAX 23 lot # R012360, expiration date 15-JAN -2020 (dose and route of administration were not reported). On 12-OCT-2018, the patient reported that his arm was swollen, red, and warm to touch, he also had a fever of 100.5 F, and achy joints, hips, legs and back. It was reported that an unspecified physician advised the patient to take ibuprofen and use ice on the arm. The nurse reported that since unknown date in October 2018, the patient no longer had a fever or achy joints and his arm was not swollen. The outcome of all the other events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported.
Dermatographism began 12/2/2021 and is well-managed with OTC Allegra and Pepcid
Patient is a 50 y.o. male with a history of end-stage renal disease on hemodialysis.  His normal dialysis days are Mondays, Wednesdays and Fridays at the clinic where he is followed by Dr.  He was transferred from the hospital in the late evening on 11/13/2021 with a non-ST elevated myocardial infarction.  He apparently had coronary stenting done on 11/11/2021.  He did have coronary artery bypass x 2 grafting done 8/18/2021 by Dr.  He was transferred to this facility for further recommendations from a cardiology standpoint.  He is on a heparin infusion.  Apparently has been compliant with his antiplatelet drugs.  Did have a Covid booster vaccine 2 weeks ago.  On exam he denies any chest pain or overt shortness of breath.  Does complain of abdominal pain and some diarrhea which appears to be a chronic issue for him.  Flagyl and Cipro has been started by the primary care physician.  From our standpoint we will plan dialysis tomorrow per his schedule.  We will await further recommendations per cardiology.  Other pertinent medical history includes coronary artery disease, type 2 diabetes, hypertension, hypothyroidism, congestive heart failure, pleural effusion requiring chest tube placement and anemia secondary to chronic kidney disease. MD note per renal MD
a lump under skin about size of a half-dollar and it is very itchy; a lump under skin about size of a half-dollar and it is very itchy; Skin in red is area; This is a spontaneous report from a contactable consume (patient). A 65-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration in right arm on 04Mar2021 at 14:00 (at the age of 65-year-old) as single for covid-19 immunisation. The patient's medical history included multi-level, bilateral foramina stenosis. The patient had known allergies to sulfa drugs, penicillin, reflex, codeine. Concomitant medications receive in two weeks included gabapentin for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 12Mar2021, at 06:00 AM, 8 days later she has a lump under skin about size of a half-dollar and it is very itchy. Skin in red is area. The patient did not receive any treatments for the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning a 92 year old retired female patient with penicillin allergy, chronic obstructive pulmonary disease, cardiac failure congestive, coronary artery disease, diabetes mellitus and atrial fibrillation who on 11-MAY-2010 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (lot # 665513/0146Z). On 11-MAY-2010 (also reported as one week after administration) the patient noticed lump and redness at injection site. White blood count (WBC) test and comprehensive Metabolic Panel (CMP) were performed (result not reported). It reported that medical intervention was required. The status of the patient was unknown. Injection site mass and Injection site erythema were considered to be other medical events by the reporter. Additional information has been requested.
tested positive for COVID; tested positive for COVID/fatigue, headache, body aches again; allergies were flaring up; Coughing; congestion; body aches; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse (female) reported that a female patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid on 31Dec2020, coughing, congestion, body aches on 24Dec2020, fatigue, headache, allergies were flaring up on 28Dec2020. The caller got her first COVID-19 injection on 21Dec2020. She didn't have symptoms until 2 days after the vaccine. She then experienced coughing, congestion, body aches, but no fever. Then the next day, she felt fine. On 28Dec2020, she thought her allergies were flaring up. She started to feel fatigue, headache, body aches again. She went and got tested for the virus. She tested positive on 31Dec2020. Caller was due for a second vaccine on 11Jan2021. She was to remain in quarantine until 10Jan2021. Caller wanted to know should she get her second shot on 11Jan2021 or should she wait. The patient underwent lab tests and procedures which included Covid-19: positive on 31Dec2020. The outcome of events for tested positive for covid, fatigue, headache and allergies were flaring up was unknown, for other events was resolving.  No further information was obtained. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events drug ineffective and COVID-19 cannot be excluded based on a compatible temporal relation between vaccination and onset of events.
Information has been received from a pharmacy technician (also reported as a healthcare worker) referring to an unspecified number of patients of unknown age and gender. There was no information about pertinent medical history and drug reactions/drug allergies. On unknown dates the patients were vaccinated with GARDASIL (lot # K006960, expiration date 19-FEB-2017, dose and route were not reported). These vaccines were improperly stored. Information about concomitant medication was not provided. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
like a flare up of gout; swollen; weird reaction; excruciating pain in toe, couldn't even put a sheet on it,toe was still sore,couldn't get shoe/sneakers on in the morning, toe was just a little sore.; This spontaneous case was reported by a patient and describes the occurrence of GOUT (like a flare up of gout), SWELLING (swollen), IMMUNISATION REACTION (weird reaction) and PAIN IN EXTREMITY (excruciating pain in toe, couldn't even put a sheet on it,toe was still sore,couldn't get shoe/sneakers on in the morning, toe was just a little sore.) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS715B) for COVID-19 prophylaxis.     The patient's past medical history included Pain in toe.    On 26-Sep-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 26-Sep-2022, the patient experienced GOUT (like a flare up of gout), SWELLING (swollen), IMMUNISATION REACTION (weird reaction) and PAIN IN EXTREMITY (excruciating pain in toe, couldn't even put a sheet on it,toe was still sore,couldn't get shoe/sneakers on in the morning, toe was just a little sore.). At the time of the report, GOUT (like a flare up of gout), SWELLING (swollen), IMMUNISATION REACTION (weird reaction) and PAIN IN EXTREMITY (excruciating pain in toe, couldn't even put a sheet on it,toe was still sore,couldn't get shoe/sneakers on in the morning, toe was just a little sore.) outcome was unknown.            Patient did not take any medications after the effect but drank lots of water. Patient has had this big pain in their toe in the past but never connected it with a vaccine. The patient received first dose on 16 Jan 2022 Lot no: 030620A, second dose on 13 Feb 2021 Lot no: 030M20A, first booster dose on 26 Aug 2021 Lot no 062E21A, second booster dose on 30 Mar 2022 Lot no 066K21A.   No Concomitant medication was reported. No treatment information was provided.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 424, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Pt stated that in addition to the expected side effects of the vaccine, he experienced extreme anger and rage for about3 days after the vaccine.  The anger resolved after that period and the proximity of the anger to the vaccine made him feel the two were related.
2-3min p/vaxs, pt felt lightheaded, rolled head to side & was unresponsive, ground teeth & grunted, slumped in chair, slow pulse & very cold & clammy; revived w/ammonia capsule; copious vomiting for 10min; had to lie down for 30min;
Burning sensation when administered  Arm soreness  Development of swelling and rash at injection site Swollen left lymph node
tenderness at  injection site; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown expiration), via an unspecified route of administration in left arm on 16Dec2020 at 06:30 AM at a single dose for COVID-19 immunization in a hospital.  Medical history included asthma and allergy to sulfa drugs.  Concomitant medications included albuterol, montelukast sodium (SINGULAIR), and unspecified multivitamin.  The patient reported that she has no reaction after receiving the first dose other than slight tenderness at injection site in Dec2020.  The patient did not receive other vaccine in four weeks.  The patient has no COVID prior to vaccination and was tested for COVID post vaccination.  The patient underwent lab tests and procedures which included nasal swab: negative on 06Jan2021. Outcome of the event was unknown.
This is a spontaneous report received from contactable consumer or other non-HCP. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a nervous system disorder/vaccine had neurological affect/neurological damaging/attacking the nervous system,  concussion (had something like concussion) and malaise (sick), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Moderna vaccine was given to a 16 year old patient. This vaccine has not been approved for administration to <18 years old.
pt recv vax & 7-8 days later exp a fever, chills & jaundice (w/ALT 339, ASt 300, GGT 332, ALK high 300, & bilirubin 6.8);pt was thought to have clinical hepatitis suggestive of cholestatic hepatitis;5 days of these sx IgM was neg;
This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, frequency, lot number and expiration date were not provided) for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004881: US-009507513-1701USA005969: US-009507513-1701USA005967: US-009507513-1701USA005968: US-009507513-1701USA005964: US-009507513-1701USA005966.
Patient received booster dose of vaccine and was not eligible for dose due to age. Patient is only 16 years old
Menarche 1/7/21.  Periods came: Jan: 7-15 (9 days)    Feb: 2-8 (4 days) then again Feb 24-25 (2 days)    Mar: 17-21 (5 days)    Apr: 7-13 (7 days)    May: 8-13 (6 days) FIRST DOSE COVID VAX May 21st    June: no period this month. SECOND DOSE COVID VAX June 11th
Day of vaccination redness, swelling, pain, warmth left thigh. Discontinued rolling and refused to bear weight on legs. Seems fatigued and has had some change in stool pattern (constipation). Recently has started rolling again. Sits well.
mom states pt broke out in rash in PM & cried constantly for approx 2 hrs; denied any fever; was taken to ER & was given DPh & rahs was gone next morning;
Severe chest pain with itching. Visited ER, given prednisone, antibiotics, and hydrocodone, with a shot of steroids and morphine. 3 days later, pain really severe from middle of chest to back of spine. Red bumps, pain. Back to ER, given CT scan, chest x-ray, blood and urine tested. Given more prednisone, hydrocodone, LIDODERM, LIDODERM patches, and valacyclovir HCL. It has been 42 days, and no relief. Still in severe pain, and rash seems to be coming back.
Patients husband came in over a week after vaccines were administered and notified us of DVT that patient had experienced with symptoms starting 2 days after receiving her vaccine . Started as pain in toes and pressure and traveling up the leg. Strong burning pain and swollen ankle and calf. Patient's son took her to the hospital a week after her symptoms began fearing it was a clot. Hospital ran tests/exams and diagnosed that she had a clot in her inguinal area and started patient on blood thinners and surgical removal. Patient believes it was the Pfizer Bivalent Vaccine or possible combination of the 3 vaccines (Pfizer bivalent, Fluad, Pnuemovax 23). Patient was released from hospital 4 days after she entered.
12/18/20 @1400 - light headache 12/18/20 @2100 - extreme soreness at injection site (right arm).  Difficulty sleeping on right arm during night. 12/19/20 @1030 - extreme fatigue.  Took a 1.5 hour nap and awoke with chills. 12/19/20 @ 1230 - extreme fatigue and chills.  Took a hot shower to help relieve chills.  After about 15 minutes in shower, began to sweat profusely and my face was flush.  *I did not take my temperature, therefore it is unknown whether or not I had fever, but I would assume so*  Finished shower and slept until 1830, but only because my daughter awoke me.  I was still tired when I awoke. 12/19/20 @ 2200 - Fell asleep and slept through the night.  Awoke at 0930 the following morning and felt better, feeling almost normal by 1200.
My platlet count is high; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (My platlet count is high) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT INCREASED (My platlet count is high). At the time of the report, PLATELET COUNT INCREASED (My platlet count is high) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided  Patient was due Saturday for last Moderna shot.
Swollen, tender and red. Went to doctor who prescribed antibiotics. Doctor told her it was a "bad batch".
A nurse reported that a 93 year old female tested positive for the hepatitis B surface antigen after vaccination with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history included renal failure treated with hemodialysis.  Concurrent conditions and concurrent medications were not reported.  On 04/01/2003, the subject received her first 40-mcg injection of Engerix-B (Lot # ENG5263A4).  Three days later, on 04/04/2003, the subject tested positive for hepatitis B surface antigen.  She was seen by a physician.  Hepatitis B surface antigen was "negative" on 04/25/2003.  The reporting nurse stated that the positive hepatitis B surface antigen was related to Engerix-B administration.  The reporting nurse stated that the subject had not yet received her second injection of Engerix-B "due to the pt being hospitalized with unrelated causes".
tingling, numbness in left side of neck and face within 2 h after immunization.  itching skin, pinpoint red rash on arms 24 h later.  Ptosis of left eyelid 5 days later.  numbness/tingling went away by 48 h. itching gone by 72 h. ptosis still present.