chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling (left leg/foot/ankle) - under control with OTC oral anti inflammatory; monitoring for life threatening event such as blood clots, difficulty breathing, chest pain, numbness; continued leg compression necessary;  Pain (left leg/head/eyes/right leg/stomach/liver/right shoulder/neck/all over constant sharp body pains) - intramuscular anti inflammatory administered in right hip; Muscle spasms (left leg to buttocks/right leg to knee) - under control with inflammatory (intramuscular/OTC oral); Loose stool and rectal sphincter spasms - feeling urgency to defaecate - on going; High Blood Pressure -ongoing; Fever- chills; fever between 99.8 and 100.9, as of 10/16/21 and on going; Fatigue - on going.
Information has been received from a physician concerning his patient's daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The patient's mother told to the physician that her daughter died in her dorm room 4 days after receiving the dose. The physician did not have much information because he did not administer the vaccine and the patient's daughter was not his patient. The reporter did not know the name of the physician who administered the vaccine. The physician considered the event to be life threatening. Additional information has been requested.
Brain fog, tingling in head, tachycardia, fatigue and arrythmia.
Patient had chill starting 2 days after surgery. Chills lasted for about 1 week. Developed a low grade fever of 100.6.  Then patient demonstrated neurological issues-patient could not remember is doctor's name or his wife's name. Could not recall the words for typical household items.
9/17/09- Flu vaccine administered. 10/6/09 Pt. went to bed around 9 p.m. became S.O.B. & L side numb. She states she couldn't swallow; her head, arm, leg & feet. She states she continued to wall around. Her dad took her to Hospital at 9:30 they sent her to private hospital. Blood work & CAT scan all negative. They dx. possible inflammatory nerves. Gave NSAIDS & pain med. No M.D. visit since.
Seizure on 02/19/2021 Narrative: Patient had a Seizure last Friday 02/19/2021. This is new-onset seizure activity started on Keppra. PMH of a Hemorrhagic stroke October 2020. Patient received the Moderna vaccine on 2/13 developed dizziness, headache and nausea all day on Monday then 4 days later had a seizure and ended up hospitalized so per hospital report may have been a combination of a weakened immune system and old stroke that included the seizure.
At the time of the second booster on May 20, extreme fatigue was experienced; first shingles shot was administered in the right arm on the same date.    On June 27, several symptoms were observed: fever (100.4), persistent cough, fatigue, runny nose, headache, sore throat, and chest congestion.  Treatment included cold and flu remedy (Alka Selzer Plus Cold and Cough).
On 1/4/2021, I received my first dose of the Moderna vaccine. Within a few days, I had brain fog, which lasted for about 4 days. I also had sinus congestion, sort of like a head cold, which lasted for a couple of weeks. During the time I had the congestion, I felt that my left ear was constantly clogged and that I couldn't hear as well out of that ear. (I was already deaf in the right ear, so it is especially that I be able to hear well out of the left ear.) Ever since I have received both the first and second doses of the vaccine, I have constantly had fluid in the left ear, and of course, this obstructs my hearing. It's sort of like having water in your ear after swimming, only you can't just drain it out. I went to a family physician, who prescribed me antibiotics and steroids in the hope that it would get rid of the fluid. However, it didn't work. I then went to an ENTs, who said he saw fluid. I underwent a hearing test, and no fluid was detected. Later, I went to another ENT, who told me that maybe it was "ear sweat." Most recently, I went to a clinic to be treated for bronchitis two weeks before the time of this writing. The doctor there detected congestion in the ear. She prescribed me Flonase and an antibiotic. Amazingly, the Flonase seems to have alleviated much of the congestion, though I still have the fluid in the left ear.
Administered the Menveo liquid component only; Administered the Menveo liquid component only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-Aug-2022 Reporter's Comments: Registered Nurse (RN) reported they inadvertently administered the Menveo liquid component only without the lyophilized component to a patient. RN unsure who the one patient was or when the dose was administered. RN mentioned thought the dose was administered on a day in between 8th July 2022 to 3rd August 2022. No additional details provided. The reporter consented to follow up. HCP provided contact for follow-up. Additional Supportive Information: The patient inadvertently administered with Menveo liquid component only without the lyophilized component to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a registered nurse concerning a 12 month old male who in approximately 1/05 recently was vaccinated SC with a 0.5ml dose of MMR. Concomitant therapy included palivizumab. One day after vaccination, the patient broke out in a papular rash on the neck, ears, and body. The patient's outcome was unknown. Unspecified medical attention was sought. NO product quality complaint was involved. Follow up information indicated that on 11/23/04 the patient was vaccinated SC in the left arm with a first dose of MMR (lot #0963). On 11/28/04, the patient had a rash. The reporter did not feel that this was a reaction to MMR. On 12/30/04, the patient recovered. It was reported that the patient had a questionable amoxicillin (+) clavulanate potassium rash in November 2004. No further information is available.
8-12 inch patches of rashes on multiple spots on my body. Started 4 months after the 2 second vaccine in May2021. Continues to this day. Tried Benadryl, Fexofenadine, clobetasol, Lidek, Medrol, Famoti; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2021 (Lot number: EL3246) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NUVARING; FLUTICASONE; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 23Dec2020, for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset 15May2021 18:00, outcome "not recovered", described as "8-12 inch patches of rashes on multiple spots on my body. Started 4 months after the 2 second vaccine in May2021. Continues to this day. Tried Benadryl, Fexofenadine, clobetasol, Lidek, Medrol, Famoti". The event "8-12 inch patches of rashes on multiple spots on my body. started 4 months after the 2 second vaccine in may2021. continues to this day. tried benadryl, fexofenadine, clobetasol, lidek, medrol, famoti" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash and patiuent was treated with Benadryl, Fexofenadine, clobetasol, Lidek, Medrol and Famoti.  Additional information: On : 05Apr2021, patient underwent PCR (nasal swab) test which was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received multivitamins within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.
The products reached negative 31.5 Fahrenheit for thirty-eight minutes with no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from another health professional.  This case involves an unknown age and unknown gender patient for whom it was reported "the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] reached negative 31.5 Fahrenheit for thirty eight minutes" (product storage error).   The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [prefilled, lot UT7383NA and expiry:30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was  reported "the reason for excursion is unknown".  It was a case actual medication error due to product storage error [Latency: on the same day].  At time of reporting, the outcome was unknown for the event.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
patient tested positive for COVID-19; patient tested positive for COVID-19; This is a spontaneous report from a contactable nurse (reporting for herself), via a Pfizer sponsored program.  A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient tested positive for COVID-19.  The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date.  The outcome of the event was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL, concerning a 22 year old female with no pertinent medical history, allergies or drug reactions who on 20-MAR-2009 was vaccinated with GARDASIL (lot no., dose and route not reported). The nurse reported that the patient was pregnant when the vaccine was administered. A pregnancy test was performed at the doctor's office that was positive. The patient's LMP was on 20-FEB-2009 and the EDD: 27-NOV-2009. Follow up information has been received from the licensed practical nurse regarding the patient. The nurse stated that the patient's last menstrual period was actually 15-FEB-2009 (previously reported as 20-FEB-2009). On 27-JUL-2009, patient experienced miscarriage at gestational age of 23 weeks. It was asked if there were any previous studies were done following the miscarriage to determine a reason but the nurse said no and mentioned that this was not the patient's first miscarriage. Miscarriage was considered to be an other important medical event. No further information is available.
Tingling in her hand; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in her hand/ paraesthesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced the event tingling in her hand/ paraesthesia. No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  tingling in her hand/ paraesthesia was unknown.
Favoring and not wanting touse her right leg.  Still favoring and not putting weight on it 7/25/2011.  Also on 7/21/11 fever 7/22/11 to 7/24/11 Rash on torso.
on 4/1/2021 the evening after the vaccine around 1am, I woke up with chills.  The chills lasted the whole night.  I woke up the next day with headache, body ache, chills, fever and a rash.  The rash appeared on my body  with the fever and went away after 30-40 minutes.   I called the Covid nurse line and was instructed to take Tylenol.  On 4/2/2021,  I still have chills on and off and felt very tired and fatigued.  By day 3 on 4/3/2021,  the symptoms all went away and I felt much better.
Redness, swelling, pain, and warmth to injection site. Difficulty sleeping. Pt instructed to use TYLENOL or MOTRIN and cool compresses.
fever; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 100 degree Fahrenheit. On an unknown date, Body temperature: 99.1 degree Fahrenheit.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The concomitant medications were not provided.  Tylenol brought his fever down to 99.1 degrees F.
The patient was feeling anxious before getting the dose. After waiting around 5 minutes or so, she reported feeling dizzy and requested assistance from the nursing students. The students help her to the floor and monitored her condition as we called an ambulance. She was able to breathe normally and respond to questions we asked. Her blood pressure was recorded at 113/78 and heart rate at 82.
Dose 2 Feb 2021 - starting within 1 week got rapid arthritis in both hands; trigger finger in 6 fingers; severe pain in right shoulder. Treated all as symptoms including 3 courses- 5 injections steroids in hands prescribed by physician; with treatments the shoulder pain subsided.   Since all adverse reactions to vaccines had been suppressed by healthcare, media, Big Tech as "vaccine hesitancy", I did not recognize these issues as adverse reactions.    I received DOSE 3 on Nov 1, 2021 not suspecting any sensitivity to the covid vaccine; Immediately within a week, the arthritis returned in hands and trigger fingers returned. The right shoulder immediately began with pain. Doctor prescribed physical therapy for shoulder, but it only got worse.    Over next 3-5 months both shoulders grew in horrible pain, that spread down biceps, triceps and forearms.  The lower back and right leg began to ache horribly in that course.  Because I read that the vaccines did not have adverse reactions, I suspected I had pulled muscles in my back and leg.    Pain in the shoulder and back were bad I could not do much of anything.  Pain was worse at night and could not get out of bed. I could not even lift my arms above the horizontal; could not lift a toilet seat or even lift a coffee pot with one hand.    Doctor prescribed anti-inflammatory pills and creams suspecting some rapid form of osteo-arthritis.  The pills alleviate the lower back and leg pain, but did nothing for shoulders.    Doctor Finally injected steroid directly into the 2 shoulders and within days-weeks , everything cleared up and went back to normal.   A scan of the shoulders note degenerative damage to the should sockets.  Likely due to the inflammation.
headache, body aches, low fever, chills, extreme fatigue even 72 hours later.  Itchy injection site, large red lump at injection site, pain at the injection site at 72 hours later.
In the hr following vax pt devel an inconsolable high pitched cry, the affected legs was red, pt screamed when it was handled for diaper change & it became swollen over & around edges of a bandage placed over inj site;
At first, I just had a runny nose for a couple days. Then one morning I couldn't smell or taste anything, and I felt achy. I went in to get a COVID test and it was positive. I felt bad for a couple of days. I had taken Tylenol, Mucinex, and Motrin to help with the symptoms.
This spontaneous report as received from a medical assistant refers to a 13 month old Child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Sars-COV-2 positive after first dose; Sars-COV-2 positive after first dose; This is a spontaneous report from a contactable nurse. A female nurse (patient herself) of an unspecified age received bnt162b2 (Pfizer-biontech covid-19 vaccine, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that she was looking for information on second dose following sars-cov-2 positive after first dose. The patient experienced Sars-COV-2 positive after first dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date. The event covid was assessed as medically significant. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient to be observed for 30 minutes beginning at 1050. Patient has a history of anaphylaxis to contrast dye for CT scans. 15 min into observation at 1105, patient reported feeling dizzy. Reported history of passing out but not associated with injections or labs. Denied blurry vision. Denied feeling SOB, throat tightening, nausea. No rash noted. Patient's VS were WNL. Laid patient flat. She reported her legs felt tingly and tight. Notified Dr.  Patient reported persistent dizziness and new onset nausea. Patient then developed a splotchy red rash on chest. No itchiness. Pt treated with 0.3mg epi, 50mg benadryl, and 125mg solumedrol. VS monitored continuously and 911 was called.
since 4/19/2021 - 2 hours after shot - I have had peripheral neuropathy in my hands and feet and legs for the  last 3 weeks and still til today, because of this I did not take my 2nd shot that was due on 5/10/2021
severe headache 05/31/21 ongoing, extreme dizziness stating 06/02/2021 ongoing
quarter size lump 17AUG-18AUG started swelling, warm to touch, redness @ inj site;
Headache, fatigue,  nausea,  muscle soreness  Lasted about 20 hours   Took Tylenol and rested
I woke up on the morning of 07/28, with pain from arm and wrist. It was swollen and hurt when I twist it. After a couple days I purchase a brace for my wrist. I went to doctor 08/09 because the night before I woke screaming in pain. Doctor gave me a different brace to help with support.
TDAP TO L DELTOID ON 11/14/2011. ON 11/18/2011 REDNESS BELOW INJECTION SITE NOTED. BRUISING AT INJECTION SITE. SWELLING IN ENTIRE L UPPER ARM.  11/21/2011, DR. VIEWED AND RECOMMENDED ALEVE AND WARM COMPRESSES BID.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "really sick"; HEADACHE (non-serious), outcome "unknown", described as "severe headache"; BACK PAIN (non-serious), outcome "unknown", described as "back pain"; FATIGUE (non-serious), outcome "unknown", described as "feeling exhaustion". Additional information: she got the 1st dose last 22Apr2021, and mentioned that she got really sick, experiencing severe headache, back pain and feeling exhaustion. She wants to ask if it will happen for the 2nd dose appointment on 17May2021 (More than 21 days). She wants to know as well if it was ok not to take the 2nd dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.