chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They are suspecting Dress Syndrome; erythema all over his body; broke out into a rash, started as a bulls eye rash in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease, Drug allergy (penicillin) and Drug allergy (ampicillin). Concomitant products included CEFALEXIN, CARBIDOPA, SILDENAFIL (VIAGRA [SILDENAFIL]) and DILTIAZEM for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome) (seriousness criterion medically significant), ERYTHEMA (erythema all over his body) and RASH (broke out into a rash, started as a bulls eye rash in the arm). At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome), ERYTHEMA (erythema all over his body) and RASH (broke out into a rash, started as a bulls eye rash in the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter mentioned patient is a mostly healthy, active farmer.  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.; 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.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 03-MAR-2016 the patient was vaccinated with an improperly stored PROQUAD (Merck) (lot # L044055, expiration date 02-MAY-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
hives on face and arms and eye area, asthma exacerbation, long standing fatigue, sore throat
Eczematous Rash Left Axilla, Intereior Left and Right Lower Legs, Posterior Left Knee.
Change in taste; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Feb2021 at 11:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included minerals nos/vitamins nos (PRENATAL VITAMINS) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Feb2021 at 12:00, the patient experienced change in taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event change in taste was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
received the first dose on 22Jan2021, then "got COVID"; received the first dose on 22Jan2021, then "got COVID"; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 22Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she received the first dose on 22Jan2021, then "got COVID" on an unspecified date in 2021 and indicated that she did not think of it as an adverse event. The outcome of the events was unknown. Due to receiving the second dose today (time of the report), she asked for any information that may supersede the CDC guidelines.  Information about the lot/batch number has been requested.
I have cancer; I have a heart problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 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 series complete; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I have cancer"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "I have a heart problem". Additional information: The patient has cancer and also, a heart problem. Patient knew these things lose their effectiveness over time and doesn't want to be in a position where she gets COVID and not protected. She thinks Pfizer needs to address this problem for older people that have immune compromised situation and believes that they need to let them know what to do or at least get give them the information.  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.
vaccine was administered outside of facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED  I20.9 ANGINA, UNSPECIFIED 9/22/2021 LLQ ABDOMINAL PAIN I20.9 ANGINA, UNSPECIFIED 9/22/2021 NONALCOHOLIC CIRRHOSIS
This spontaneous report was received from a registered nurse referring to a 12 month old male patient with tongue tie. The patient's drug reactions or allergies were not reported. On 13-NOV-2017, the patient was accidentally vaccinated on the right leg with an expired dose of M-M-R II lot number: L043704 (expiration date: 04-NOV-2017), first dose, subcutaneously, for prophylaxis (strength and dosage schedule were not reported). On the same day, the patient was also vaccinated with VAQTA (lot number: N012324, expiration date: 05-APR-2018) on the right vastus lateralis, PREVNAR 13 (lot number: R73811) on the left vastus lateralis and VARIVAX (lot number: MO3208) on the left vastus lateralis for prophylaxis. No adverse effects or problems were reported. The nurse contacted an agent, who informed him that the vaccine was okay and there was no need to revaccinate.
temperature of 100.4; he had chills; little swelling around the injection site; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), dose 2 via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included budesonide at 6 mg, once a day. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient on 05Mar2021, experienced a little swelling around the injection site. 7 days later on 10Mar2021, the patient had chills, and a temperature of 100.4. The patient wanted to know whether it was normal to have these side effects even days after receiving the vaccine. The patient was taking 6 mg a day of Budesonide, a medication that weakens his immune system and queried whether this medication affected the vaccine's efficacy. The patient underwent lab tests and procedures which included body temperature: 100.4 on 10Mar2021. The clinical outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Headache; Tiredness; Nausea; Numb; Lips tingle; Vision; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0151) via an unspecified route of administration in the left arm on 08Apr2021 at 12:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergy to sulfate. Concomitant medications included alendronate sodium (ALENDRONATE) for an unknown indication from an unknown date and unknown if ongoing. 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 08Apr2021, the patient experienced headache, tiredness, nausea, vision, numb and lips tingle. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tiredness, nausea, vision, numb and lips tingle were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Started another period, and bled for a full 5 days/ breakthrough bleeding; Fever; Chills; Shivering; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Apr2021 at 14:30 (at the age of 36-year-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. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced fever, chills, shivering, headache and fatigue for about two days. On 03May2021 the patient experienced irregular menstruation. She was on last 2 days of period while vaccination and after 10 days of the vaccine, started another period and bled for a full 5 days. The blood was somewhat thinner than it is in a usual period. She had rarely had such breakthrough bleeding in between her cycle and felt was likely a side effect of the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event fever, chills, shivering, headache and fatigue was recovered on an unknown date in 2021; while that of irregular menstruation was unknown at the time of report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt called LPHA to report she was seen in the ER on 4/8/21 for a potential blood clot in her left leg. Pt reported she awoke from sleep late 4/7/21 early 4/8/21 with severe pain in her left leg. She reported it hurt so bad she was "screaming". She stated it felt like a "charley horse" and her husband noted a knot in her leg. She went to the ER on 4/8/21 due to the inability to put pressure on her leg and/or walk on her leg. She reports having a CT scan of her chest at the ER and no clots were noted. She stated they did not image her leg at that time and scheduled an ultrasound/doppler for around 4/27. She was prescribed some oral blood thinner, but could not recall the name. She stated she stopped the blood thinner on 4/12/21 after the new reports regarding the J & J vaccine and not using blood thinners to treat. Today she states her leg is purple, black and blue and is swelling more when she is up on it at work. RN instructed pt to call her primary provider regarding stopping the blood thinner and to see if re-evaluation of her leg is needed. Pt also instructed to seek emergency treatment for increased swelling or pain to her leg, headache, abdominal pain, shortness of breath or any other concerns. Pt plans to speak with or see her primary provider today.
skin numbness sensation  in right side back, migrating across top of back at shoulder level. extreme sensation of bugs crawling on skin in those areas.  tingling and numbness down left arm. tingling and numbness in l thumb and first 2 fingers of left and right hands. very high sensitivity in touch on those digits causing sharp pain in fingers at sight of pressure or contact. tingling and numbness on right and left thigh and calf.  slight tingling and numbness in middle toe of right foot.
Allergic reaction; This is a spontaneous report from a  non contactable consumer reporting for self.  A patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction on an unspecified date with outcome of unknown.    No follow-up attempts are possible. No further information is expected. Information about Lot/Batch Number cannot be obtained.
Numbness & Tingling in Right Ankle/Foot and Right Hand/Wrist 20 minutes post vaccination. Sensation lasted approximately 30 minutes then stopped.  Worried about second future dose complications.
A tingling and numbing sensation that started on my lower part of the body, spread up to to my chest up to my nipple line. Lost the ability to walk and use my hands
Prolonged, continuous cardiac arrhythmias, approximately 12-15 hours duration  despite normal medication that usually controls them. Began about 30 hours after injection, resolved at about 48 hours after injection.  Swelling, redness below injection site, warm to touch approximately 6?x 3? area. Began about 30 hours after injection. Swelling has lasted at least 36 hours at current date. No signs of improvement to this point despite repeated application of steroid cream, oral antihistamines and  h2 blockers.
15 yo female patient presented to clinic for influenza vaccine. Vaccine consent filled out and signed by parent. 0.5mL FluBlok Quad administered IM to L deltoid. Patient educated to remain at clinic for observation x 15 minutes. No adverse reaction or sx noted. 2/18/21 18:15 After two patient identifiers verified, father of patient notified FluBlok was given. States no unexpected effects or sx noted. Denies having other questions or concerns at this time.
patient stated that she was shivering with high fever (around 103F) and had body aches at around 8pm of the same night she got her flu shot. She went to the hospital for the condition.
Pt states pain and burning going down arm to wrist and up to shoulder immediately upon receipt of inj. lasting 3 days. Entire upper arm area became swollen and reddened lasting 5 days. Deltoid area bruised.
PT WAS FULLY VACCINATED. DOSE 1 - 3/8/2021 LOT 048A21A; DOSE 2 - 4/5/2021 LOT 021B21A. S/O 8/18/2021. TESTED + 8/19/2021
Dizziness, Myalgia, Tachypnea & NauseaVomiting Narrative:
-severe chills, body aches, fever (101), fatigue, swollen arm -started Wednesday and still ongoing on Saturday although no fever and body aches now  -loss of appetite (only one meal since Wednesday)
Pediatric 5 to 11-year-old dose given to patient (13 years old). No adverse effects.
10-26-11 Patient came to pharmacy. Muscle aching - above elbow - drawing down to forearm on the left arm - site of vaccination - site sore immediately after vaccination on 11-15-11 talked to patient a little better applying heat per consultation with a nurse did not see MD - at elbow pain during night more painful. 12-21-11 pain around elbow and up to injection site and band pain.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received SHINGRIX over two months before the date of reporting. The patient asked how long should they wait after shingles occurs to obtain the second dose of SHINGRIX and could SHINGRIX be administered with an active case of shingles.
Same day that patient received the vaccine she had a headache. Patient broke out in hives.  Patients has rashes all over her body.  Patient has a big rash on left side close to under arm pit. Arm was sore to the point that patient could not move arm. Patient was dizzy and had extreme chills and fatigue.
Patient had syncopal episode and hospitalzied for a STEMI, underwent a heart catheterization. He was discharged to a rehab.
55 y/o woman with severe obesity with BMI of 39, asthma, GERD, preDM, HLP,  who presented  to ED on 1/3 for evaluation of cough, wheezing, worsening SOB, diarrhea and weakness. Patient lives with her Mother. Mother's caregiver was tested positive for covid 8 days PTA. Patient was in isolation but developed symptoms on 12/29. Now covid positive on admission.   Hospital course:    COVID pneumonia with acute hypoxemic respiratory failure: Given that she was hypoxic and needing 2 L O2 to be 94-95%, she was started on steroids and Remdesivir. Currently on RA at rest and on ambulation. She has received 5 days of Decadron 6 mg daily, to complete a 10 day course at home. She has received 4 days of remdesivir (RDV), originally she was reluctant to take RDV due to possibility of hepatotoxicity but later on she agreed. She has received 4 days of RDV with resolution of hypoxemia on discharge. She will resume PTA  inhalers including albuterol, Atrovent and Wixela. I prescribed Robitussin AC PRN and zofran on discharge.    Acute asthma exacerbation: due to covid infection. Wheezing has resolved, on RA.    Primary Procedures:  none   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Asthma exacerbation due to covid pneumonia and acute hypoxemic respiratory failure.
Felt lethargic 12 hours after, arm very sore from 7th to 10th. Then noticed rash. Just mildly itchy and raised. As of 4/12 appears to be getting less pronounced.
I have an IUD (Mirena) and besides spotting for a day or two when a new device inserted, have had no problems and have not had a menstrual cycle for past 15 years.  Three days after my first vaccination, I started a menstrual cycle-a heavy cycle-and have not stopped(besides a time from a  Thursday through a Tuesday night) - i have not stopped bleeding.
After drawing up and administering 3 doses, it was noticed that the vial was not very full. Upon inspection and questioning the person who reconstituted the vial, it was determined that 1.6 milliliters of diluent had been used, rather than 1.8 milliliters.  The vial was discarded, affected patients notified, and a new vial drawn up for the remaining recipients. No adverse events reported at this time. Employee was instructed to verify graduation marks on the syringes prior to drawing up diluent.
The day after I had little bit of soreness on my deltoid, nothing major, but 3 days later, the Saturday I felt a sore throat and by night it was significant enough, I started taking Motrin. My lynphnodes were a little swollen. I contact employee health who set me up with a covid test (negative) and  about 3 weeks earlier I had a similar sore throat that prompted me to have a covid test it was negative as well.
No additional AE; A medical assistant reported that an additional dose of  was administered to a patient after the patient had received the recommended dose of PROQUAD within the past two months.; This spontaneous report has been received from a medical assistant, regarding a 4-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On an unspecified date in 2022 (reported as since turning 4 years old in July 2022), the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported).  On 29-SEP-2022, the patient received a second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (lot number: W020551, which was determined to be valid by the validation lot team, with an expiration date on 26-DEC-2023) strength, dose, route and anatomical location of administration, lot number and expiration date were not reported). This been within the past two months of receiving the firs dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Inappropriate schedule of product administration). No additional adverse event was reported.
Started feeling pain within an hour or 2 of the vaccination but thought it was  a slight reaction to the shot.  Over the next several days my right should became extremely painful.  I can not lift my arm and the pain is excruciating.  There is a constant pain, along with sharp pain radiating the length of my arm.  I have to keep my arm completely tight against my stomach.  When I vomited from the pain after catching myself from a fall, I made an appointment with Dr.  He prescribed 800 milligrams of Ibuprofen and sent me for a MRI.  I returned after completing the MRI and could not believe  that my rotator cuff was not torn completely.  After the appointment I thought back to what could have triggered my extreme pain, as it was not a tear.  I realized that the pain started almost immediately after my shot.  I did not know there could be a correlation between the vaccine and my shoulder pain until I googled my symptoms.  I have an appointment with an Orthopedist on 10/25/19
Initial case received from a consumer (the patient's parent) via Novartis on 03 July 2014. A 13-year-old female patient, with no reported medical history, developed grand mal seizure after she received a shot of MCV4 on an unspecified date (manufacturer, lot number, route and site of administration not reported). The reporter stated that the patient was transferred from the local health unit to the ER via ambulance after having a grand mal seizure. She received a urine test, blood test, chest X-Ray and EKG. All these tests were normal. When the patient was dismissed to return home, she stood to get dressed and had another seizure. She was kept longer and given fluids. She was admitted overnight. She was then transferred to another hospital where she was observed and then released with orders for outpatient tests. Outcome was not reported. Documents held by sender: none.