chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am sleeping my life away/ I have to lay down now; Sore left arm and a little bit red; Sore left arm and a little bit red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm and a little bit red), SOMNOLENCE (I am sleeping my life away/ I have to lay down now) and ERYTHEMA (Sore left arm and a little bit red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm and a little bit red) and ERYTHEMA (Sore left arm and a little bit red). On 05-Mar-2021, the patient experienced SOMNOLENCE (I am sleeping my life away/ I have to lay down now). On 06-Mar-2021, PAIN IN EXTREMITY (Sore left arm and a little bit red) and ERYTHEMA (Sore left arm and a little bit red) had resolved. At the time of the report, SOMNOLENCE (I am sleeping my life away/ I have to lay down now) had not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient had sharp pain in shoulder during what he describes a deep injection, and subsequently has had right elbow pain which radiates to the right hand as well as hand and forearm muscle weakness intermittently. These all developed in the 24-48 hour period post-vaccine after the shoulder pain subsided.
After taking the shot, I could barely walk up and down the stairs. I couldn't bend my knees. I was having difficulty walking because I was in so much pain.  I was having a lot of joint related issues. I received cortisone shots in my knees from my doctor. Within a week, things started to get a little better. I still have some difficulty walking, but I could currently stand without help.
On 1/28/2021 in the morning I was feeling chills, body aches, muscle aches & no fever. Then around 11pm I had the non stressing appointment with my OBGYN the baby heart rate was around 170s 180s & usually it was always at the 140s it was not reactive it was just high, My doctor sent me to the hospital for observation I was there for 6-7hrs & then I was released. The baby heart rate came back down.
Rash under arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced RASH (Rash under arm). At the time of the report, RASH (Rash under arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
rash all over 2wks p/shot;rash itched;MD felt this was related to flu shot
pt started fever 2 hrs p/vax still has 13AUg93; as high as 102 @ times; c/o neck pain & h/a on 11AUg93; on 12AUg93 had inflammation & pain @ inject site lt deltoid; seen by MD; dx was severe local reaction to DTP;
Injection site red, swollen, painful, itchy and hot per patient. Patient went to hospital to have site checked.
On 3/1/2021 - Pt wakes up and has a rash on her left arm where she had the shot injected on 3/02. The rash continues to get larger and it is withholding heat.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 9-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 29-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
This spontaneous report concerning an unspecified number of patients of unknown gender and age was received from an office manager. The patient's concurrent conditions and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (strength and route were not provided), 3 doses of lot L042265, expiration date 26-OCT-2017 and 12 doses of lot M006722, expiration date 08-FEB-2018. There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE BREATHING RELATED SLEEP DISORDER OBSTRUCTIVE SLEEP APNEA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Patient immediately after vaccine began to have itching and red flat rash to right arm. Denied any SOB. Denied any lips/mouth or throat swelling. Was given Benadryl 50 mg PO, rash resolved within 15 minutes. Patient stated area of injection was numb.
Patient received shot in left deltoid Thursday afternoon, by Friday she started getting "red, lumpy, bumpy, painful, burning, stabbing" feeling under armpit. Over the next week, bumps appeared at right shoulder, middle of upper back, and dry mouth/throat. She admits to taking Benadryl topically and by mouth, I let her know that the Benadryl likely caused dry mouth.
PEA-SIZED MILDLY HYPERPIGMENTED AREA WITH DIME SIZED KNOT UNDERNEATH TO RIGHT LOWER THIGH NOTICED THE DAY OF INJECTION PER MOTHER. MOTHER STATES THAT THE DISOLORATION AND KNOT HAS NOT CHANGED IN SIZE BUT DID PEEL AT ONE TIME.  WAS ADVISED INITIALLY TO APPLY WARM COMPRESSES TO THE AREA AND MASSAGE WITH NO CHANGE. PT SEEN IN CLINIC 11/26/2018 WITH NO CHANGE AND INSTRUCTED TO MONITOR FOR ANY CHANGES AND REPORT.
Left Supraclavicular Lymphadenitis the day after receiving the vaccine in Left Deltoid
Child brought to downtown family clinic after receiving vaccine at clinic.  Complained of shortness of breath, bilateral eye swelling and upper lip swelling.  O2 administered.  Assessed by physician.  911 called and patient transported to ER.  09/03/2003 Mother returned to clinic to pick up forms.  She stated child treated with Benadryl and site ploscrpion.  Child appeared well and in no distress.
injection site pain for days 1,2,and 3. fatigue on day I  Muscle aches on day 4. rash on rt temporal area on day 8
metallic taste in his mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in his mouth) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced DYSGEUSIA (metallic taste in his mouth). At the time of the report, DYSGEUSIA (metallic taste in his mouth) had not resolved.            The patient experienced metallic taste in his mouth after his second dose.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-420720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received and updated patient demographics, product details and event onset date. On 21-Dec-2021: Follow up received contains non significant information.
Excessively heavy period about 3 weeks after second shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 06Apr2021 14:00 as DOSE 2, SINGLE for covid-19 immunization (23 year when vaccinated) at public health clinic. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 16Mar2021 14:00 as DOSE 1, SINGLE for covid-19 immunization (23 year when vaccinated) and experienced irregular periods and heavy menstrual bleeding. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient reported that since having both the vaccination the patient has been having excessively heavy period about 3 weeks after second shot with huge clots, and she bleeds so much that she soaked through tampon and pad in an hour. The patient had to visit the doctor in the emergency room. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
On 01/06/2021 I woke up very dizzy and slightly nauseous. On 01/07/2021 I began to have cold symptoms such as head congestion sneezing and sore throat. I got COVID tested at work on 01/05/2021 which was negative . I had to miss work on 01/08/2021 due to my continuing symptoms which now included loss of taste and smell. I tested positive on 01/12/2021.
Patient felt normal when left exam room and at check-out window. While walking to car in parking lot, became dizzy and vomited (about 2:40pm). Returned to office and observed. Vitals check multiple times. Patient was alert, no LOC but doesn't remember episode. Near syncopal. Not cardiovascular collapse. Strong heart rate, alert and interactive. On second attempt to leave about 3:15, patient felt like he was going to pass out walking down hall. Returned to exam room and was observed and vitals check multiple times for 30 minutes then wheeled to car and stable for transport. Family was called 45 minutes after leaving and still stable.
the left one is swollen and I don't know how to explain it except it's "thicker".; migraine; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on 03Mar2021 as dose 2, single for covid-19 immunisation. Medical history included knee replacements and migraine. Concomitant medicine were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced the left one is swollen and i don't know how to explain it except it was "thicker" and migraine . Caller enquired whether the patient can take an Aleve for a migraine. It is 4 days after the vaccine. The migraine was not necessary due to the vaccination it was not unusual for the patient to get them (not clarified if having migraine before vaccine, hence conservatively captured as an event in the tab. The patient have had trouble with knee replacements and the right one was fine, the left one was swollen and do not know how to explain it except it was thicker. Consumer stated that patient received second dose of Pfizer Vaccine and understand that the patient was not supposed to be taking any pain relievers before the patient got the second vaccine which patient did not but the patient had issues with migraine can the patient take Aleve, the patient got the second dosage on Wednesday the third. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In September 2021 I started noticing a rapid and irregular heart beats. I recorded my heartbeat rhythm to my watch then sent it to my PCP. Then he referred me to a cardiologist. I was prescribed Metoprolol ER. Last week the irregular heart beats started again.
Passing out...4 times.   I woke up, took my shower, stepped out and passed out..hitting the wall behind me.  I woke...stumbled to the bed and passed out on the floor.....woke from that and made it to the chair and passed out while in the process of sitting.  The last time was while trying to get dressed....bent over to put on my jeans and passed out for the last time.  Was very sick feeling for 2 days longer.  Not woozy or faint...just...off...sick like a fever feel...but no fever at all...took my temp, normal.  I was bruised over my body from the passing out and hitting walls and floors.   My arm that had the injection hurt for three weeks.  Haven't felt right ever since...just feel...funny and off.
rebound COVID/COVID-19 treatment; rebound COVID/COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0150), in right arm and on 23Apr2021 as dose 2, single (Lot number: EW0171) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Dec2021 as dose 3 (booster), single (Lot number: 051F21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other medication in 2weeks. No known allergies reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "rebound COVID/COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product- COVID 19 Treatment; Brand: Paxlovid; Treatment start date- 04May2022; Treatment start date- 09May2022; Indication: Treatment of Covid-19. Adverse event start date: 13May2022.
Pt was given the vaccine at visit . Pt states he  had visual disturbance and sore throat . Pt went to the ER for Evaluation. The ER physician  prescribed nothing.
Patient got an unusual amount of swelling the next day.  Came back to the pharmacy that Saturday.  Pharmacist on duty gave a Benadryl with no effect.  Came in 9-25-19 swelling had gone don't, but was still red and warm to the touch.  Wanted swelling report as side effect
Fever and rash and crying  18 hours after vaccines.  Parents took to ER and were instructed to use Tylenol.  Mom gave Tylenol and child sleeping well today and rash resolved.
Burning in bilateral feet began within 1 week after receiving the flu shot. Burning in bilateral hands "on fire" started the end of January. Difficulty using arms, walking, and speaking progressed to point now of barely being able to use arms, walk and speak. In last month, diagnosed with Motor Neuron Disease. The medical record received on 1/2/04 states anxiety, depression, parkinsonism, cerical radiculitis, shoulder pain, dizziness and hands cold. 60 day follow up on 11/26/03: "Vaccine recipient did not recover from adverse events that were reported for this vaccination.  Diagnosed with ALS.  Recipient can't walk and can't move arms.  Speech ability is poor.  Progressively getting worse.  This information collected from recipients daughter." Information from Discharge summary states neuropathy, anorexia, weight loss, dysphagia, urinary tract infection; from medical record, herniated disc, twitching. msv
Nausea; vomit; very weak; Body muscles pain; feeling sick; This is a spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that:  A 73-year-old unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via intramuscular route of administration, on 23Mar2021, 10:00 AM, as dose 2, single for COVID-19 Immunisation. Medical history and concomitant medications were not reported. The Patients familial history included Lupus, Arthritis, Asthma. Historical vaccine included BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Pfizer EN6198), via intramuscular route of administration, on 02Mar2021 at 12:00 Noon, as 1st dose, single for COVID-19 Immunisation. On an unknown date, the patient experienced nausea, vomiting, very weak, body muscles pain and feeling sick for 3 or 4 days. The patient did not received any treatment. Prior vaccinations within 4 weeks was none. The outcome of the events were recovered.
About 6 family member received their 2nd dose 2 weeks after the 1st dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (About 6 family member received their 2nd dose 2 weeks after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (About 6 family member received their 2nd dose 2 weeks after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (About 6 family member received their 2nd dose 2 weeks after the 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.
Moderna COVID-19 Vaccine EUA:  I felt very sore in my arm a few hours after the shot.  About 15 hours later, I felt very fatigued.  Just shy of 24 hours I had chills and felt as if I was running a fever but was not running a fever.  36 hours in I was extremely dizzy and this lasted about 8 hours.  In about 48 hours I developed a large red rash about the size of my hand on my arm and it was hot to the touch.
chills; fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (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 (previous dose details , prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=2,), for COVID-19 immunization; Covid-19 vaccine (prev dose product=COVID 19,, prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: lot unknown reason was Not available/provided to reporter at the time of report completion,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
REDNESS, HEAT, SWELLING AND PRURITUS TREATED WITH BENADRYL
Full blown flu symptoms began 3.5 hours after shot lasting 36 hours. Began shingles symptoms 2/12/2021. Have been under the care of my GP, OD, and Dermatologist since. Still sick as of today 3/4/2021.  2nd shot schedule 3/5/2021. Conflicting advice on receiving that.
This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced aches, fever (101.3 (units unspecified) at highest) and chills. The patient slept all day and night and felt better by next day afternoon. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021, the patient underwent lab tests and procedures that included COVID-19 test (Nasal swab) and tested negative. The clinical outcome of the events aches, fever (101.3 at highest) and chills was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
10 minutes post dose patient starting to feel weak and light headed, became pale and felt as if she was going to pass out.
Pt waited for 15 minutes post vaccine. No adverse reactions noted at that time.  Pt mother did contact network this morning, with a fever.
AT OR ABOUT 11:30 AM ON 04 MAR 12. PATIENT WAS ADMINISTERED THE INFLUENZA VACCINE INCORRECTLY. ROUTE INDICATED INTRAMUSCULAR, ROUTE ADMINSTERED NASAL. PATIENT OBSERVED BY MEDICAL PROVIDER. NO ADVERSE REACTION.
Miscarriage  Estimated date of delivery 09/12/2021 I was give IV fluids