chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 15NOV96 & presented w/demyelinating disease & was hosp on 3DEC96;6DEC96 pt is being treated w/solu-medrol & is being treated as an acute mult sclerosis pt;
no adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report was received from a health professional (medical assistant) refers to a 5 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, route of administration, anatomical location and dosage information were unknown) of lot # S000133 and expiration date of 02-JAN-2021 for prophylaxis.  The concomitant medication included sterile diluent (lot# S015085 and expiration date 31-JAN-2022) which was reported to be stored properly (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of -9 degree Celsius (C) to 8 degree Celsius (-5.3 C) for a time frame of 32 minutes. There was previous temperature excursion reported as -9 degree Celsius (C) to 8 degree Celsius (-3.4 C) for a time frame of 3 hours and 15 minutes. Data logger was involved. The outcome of product storage error was unknown. No product quality complaint (PQC) was associated with this report.
15 min post vaccination   face/ears bright red, flushing . Patient reported feeling of "heart racing" , dizziness, heat about the face.  Vitals taking by staff bp 138/86 given 50 mg Benadryl po. Patient reported dizziness, heart racing subsided. facial coloring returning to norm by 240. Received ride home from staff. Patient reported that she forgot her blood pressure med that morning. She was advised to take it upon arrival home. and follow up with additional Benadryl q 6 hours if needed. monitor at home. Family with monitor at home. Patient was stable.
Gout; on and off nauseated; twitching and cramps in hamstrings, feet and hands; twitching and cramps in hamstrings, feet and hands; This is a spontaneous report from a contactable consumer. This 53-year-old male consumer (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:00 (at the age of 53-years-old) (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6200) as DOSE 1, SINGLE for covid-19 immunisation and experienced Hand swelling, Numbness and tingling in fingers/numbness and tingling in toes, Feet swelling, Ankle swelling, Cold chills without a fever, Fatigue and Gout. The patient was on and off nauseated and twitching and cramps in hamstrings, feet and hands on 02Apr2021, the patient states after the second shot that he got on 01Apr2021 this went on for a three-week period where he could not eat hardly, and he never threw up but always felt like it. He started getting better around 23Apr2021 or 24Apr2021. He still had it a little, but it was not as severe. Patient also had gout on 25May2021 and patient states last night at three in the morning he woke up with unbelievable pain and swelling in his left foot where he could not walk on it so he went to the emergency room and the doctor listened to all his symptoms and said they would treat his foot. Patient states they did not aspirate the joint in his foot he was just given a steroid injection and some pain meds and now the doctor wants him to see a podiatrist for the aspiration. Patient stated he was on pain meds and cannot walk because of it. He stated he did want to mention he had also been having twitching and cramps in hamstrings, feet and hands as well but not all the time as it comes randomly. Patient had not administered additional vaccines. Patient had no vaccination within 4 weeks and not prior also. Informed patient for medical advice to contact a doctor but if the patient was wondering if the symptoms, he had been experiencing had been reported side effects of the vaccine this DSU agent can transfer him to USMI. The outcome of event nauseated was recovering and all other events outcome was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Oct 4 2012 received 3rd GARDASIL and one month later developed headaches, visual changes and seizures along with optic neuritis. MRI showed inflammation in Rt frontoparietal region with elevated IgG levels. Eval by neuro and immunology felt to be autoimmune inflammatory process.
BLOOD PRESSURE DROPPED TO 83/51 SHORTNESS OF BREATH, FEELING FAINT, DISORIENTED,
burning; neck,right hand,left ear itching; she got a rash on her neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 11:00 (Lot number: FE3592) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BURNING SENSATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "burning"; PRURITUS (non-serious) with onset 21Oct2021, outcome "unknown", described as "neck,right hand,left ear itching"; RASH (non-serious) with onset 21Oct2021, outcome "recovered" (2021), described as "she got a rash on her neck". Additional information: she is going to go into urgent care since she is right there. Day 13 after 1st COVID shot I had a rash appear on my neck and went away after a few days.   No follow-up attempts are possible. No further information is expected
Patient re male 6 years with Herpes Zoster. Dad states child never had wild C. pox has history of eczema in past. Dad wants to know if varicella vaccination could have pre-disposed him to the Herpes Zoster event. If there any survey to check if he did cpox: asymptomatic course. His is a new patient to me. We did not give him his varicella shot.
8 days after both  injections excruciatingly painful back of arm, side of arm, and shoulder pain.   I have head aches now periodically as well which I never had before these injections.  Returned to the doctor after the second shot 4/26/2021 and was giving a prednisone prescription for 3 days of 20 mg and was told to take the Norco I am given for spine pain management for three days.  I took all the meds and the pain subsided for 3 days.  I call the doctors office back and asked if he wanted to send the prescription again because the pain persist.  I was told that he has done all that he can do and  I would be referred to an orthopedic doctor on Monday May 3rd, 2021.  Its May 6th and I am in screaming pain and still no appointment.
It started with a tingling in my tongue, my BP went super high and my face was all red and a headache afterwards. My BP went down about 25 min later. I was just monitored at the vaccination site, did not go to the ER.
5PM C/O TIGHTNESS TO THROAT,LIPS 'TINGLE' AND TONGUE FEELS'THICK'.  DIFFICULTY BREATHING, SWALLOWING OR SPEAKING. A/O X3, PINK, W/D, RESP REG WITH EASE.  NO NO ACUTE DISTRESS NOTED. BENADRYL 25MG GIVEN P.O. 5:15PM ALL SYMPTOMS IMPROVED; SHE HAS BENADRYL AT HOME AND WILL CONTINUE AS NEEDED. 5:30PM  HOME WITH HUSBAND; NO DISTRESS AT THIS TIME. F/U: 2-10-21 9AM TC PT STATES SHE FEELS BETTER, STILL HAS SL TINGLING OF LIPS (STATES THIS IS HOW SHE FELT AFTER THE CORTISONE INJECTION).  ALSO HAS SOME CHILLS.
Local injection site reaction. Pt. given Fluvirin and Pneumovax on 10/3/13. She said did not feel well on 10/4/13 on 10/5/13 her arm "ballooned up" at injection site. It was hot and sore to  touch. Pt. took Benadryl and was fine by next day. Reported to pharmacy on 10/8/13 arm was fine at that time.
headache; chills; joint pain; body ache; This is a spontaneous report received from Pfizer-sponsored program. A male contactable consumer (patient) reported for himself that, a male patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 1 intramuscular on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient called to report that on the 27Mar2021 he experienced headache, chills, body ache and joint pain three days after he received his 1st dose on 24Mar2021, his 2nd dose schedule was on 17Apr2021. The patient experienced headache, chills, joint pain, and body ache on 27Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
lethargy; sleepy; sore area were shot was administered; body ache; sinus like headache; nausea; fever; restlessness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 19-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: sore area were shot was administered), general body pain (Verbatim: body ache), sinus headache (Verbatim: sinus like headache), nausea (Verbatim: nausea), fever (Verbatim: fever) and restlessness (Verbatim: restlessness). On 20-MAR-2023, the patient experienced lethargy (Verbatim: lethargy) and sleepiness (Verbatim: sleepy). On 21-MAR-2023, the outcome of the injection site pain, general body pain, sinus headache, nausea, fever and restlessness were resolved (duration 2 days) and the outcome of the lethargy and sleepiness were recovered/resolved (duration 1 day).   It was unknown if the reporter considered the injection site pain, general body pain, sinus headache, nausea, fever, restlessness, lethargy and sleepiness to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, general body pain, sinus headache, nausea, fever, restlessness, lethargy and sleepiness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient just got a shingles shot 3 days ago and first night had ache body, sinus like headache, nausea, fever all night with restlessness and sore area were shot was administered, next day same with lethargy and very sleepy and third day everything subsided. The patient had seen family who has had shingles and it can go on for over a month of non stop pain and all of the above symptoms with rash and skin irritation. The patient would be having the second shot in 2 months. The follow-up could not be possible as no contact details were available.
Covid arm.  Took zyrtec and it went away, but returned on 9th day after vaccine.  Visited clinic advised to put heat on site.  I have a picture of my arm.  Took zyrtec and applied heat.  It healed within that week.
Cold to Hot Sensation Going Up and Down the Arm; Fatigue; Chills; a Rash Near the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE RASH (a Rash Near the Injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE RASH (a Rash Near the Injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE RASH (a Rash Near the Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
fever; aches; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (aches) and VACCINATION SITE PAIN (Vaccination site pain) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 on 04-May-2021. Concomitant products included METFORMIN for an unknown indication.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-May-2021, PYREXIA (fever), MYALGIA (aches) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, Heart rate: 122 (High) 122 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Woke up on 1/15 with dry, irritated nose, mild nausea. My nose continued to get stuffier as the day went on and I began to have a slight headache. On 1/16 my nose was very stopped up and I had a constant headache and an upset stomach, fatigue. On 1/17 I was very stopped up with a intense headache. Today, 1/18 my symptoms are much better.
Pfizer vaccine , 2 doses. Second dose on Friday 4/16. On Saturday had a strong chest pain, spend all day Sunday with upper back pain and chest pain. Monday pain got stronger, Tuesday on and off chest and upper back pain. Went to the hospital and he had suffered a heart attack. No primo medical conditions of anything cardiovascular related. Only medical hx he has is kidney stones. He is currently at the hospital pending catheterization.
Soreness in arm; Headache; Backache; Stomachache; Rash; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included transverse myelitis. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021, the patient experienced soreness in arm, headache, backache, stomachache and rash. The events did not result in doctor or other healthcare professional office/clinic visit, 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 soreness in arm, headache, backache, stomachache and rash was resolving at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt. returned for Rabies#2 on 4-26-07. Received Rabies #1 on 04-19-2007. Pt. stated that on Saturday, 4-21-2007 around 12 noon, that he began to have tingling in Right arm, difficulty seeing in Right eye,unable to speak for approximately 3-4 minutes and numbness on right side of lip. His father witnessed this episode. After several minutes, pt. states he was weak. Pt. able to go lay down. He states he took a nap for two hours.  Upon awaking, he was completely well. Pt. states he did not seek medical help because he felt better. Denies any previous episodes or any since that time. Rabies #2 not given. Referred for MD evaluation. 05/15/07-records received for DOS 4/26/07-C/O loss of vision in right eye, aphasia, right side numbness and facial droop. Occurred a few days after rabies shot. PE unremarkable. Assessment:Episode of acute visual changes/aphasia/paresthesia, differential includes TIA and migraine equivalent. MRI/MRA to be scheduled.
muscle pain; headache; dizziness; He is sick; stay in bed; constantly miss work; Body pain for 3 months now; Mild body pain (legs, arm); This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (muscle pain), HEADACHE (headache) and DIZZINESS (dizziness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2006, Cholesterol since 2006 and Diabetes since 2006.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild body pain (legs, arm)). On 10-May-2021, the patient experienced MYALGIA (muscle pain) (seriousness criterion hospitalization), HEADACHE (headache) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION COMPLICATION (He is sick), BEDRIDDEN (stay in bed), IMPAIRED WORK ABILITY (constantly miss work) and MYALGIA (Body pain for 3 months now). The patient was hospitalized on sometime in July 2021 due to DIZZINESS, HEADACHE and MYALGIA. At the time of the report, MYALGIA (muscle pain), HEADACHE (headache), DIZZINESS (dizziness), PAIN IN EXTREMITY (Mild body pain (legs, arm)), VACCINATION COMPLICATION (He is sick) and MYALGIA (Body pain for 3 months now) had not resolved and BEDRIDDEN (stay in bed) and IMPAIRED WORK ABILITY (constantly miss work) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Patient lab data reported as MRI and blood work with no diagnosis. No concomitant medication were reported. Patient has taken a lot of painkillers as treatment drug and stayed in the bed.  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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Followup appended with newevents, current conditions were added.; 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.
12 hours after receiving the vaccine, I had chills & a fever.  It has continued for 2 days.  The fever was between 99.5 & 101.3.  Tylenol is the only thing keeping the fever down
This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 22-year-old male subject received on 24 August 2010 an injection of ACAM2000 (lot number not reported), and the following vaccinations on 26 July 2010: Anthrax (manufacturer and lot number not reported) and Hepatitis B (lot number not reported). The subject had no medical history. On 04 September 2010 the subject had an abnormal troponin I of 17.30 and an abnormal electrocardiogram (ECG). On 05 September 2010 he had a normal magnetic resonance imaging (MRI) of the heart. The result of the echocardiogram was not available. On 13 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Patient screamed inconsolably for 3.5 hours. He also apparently went limp for a few seconds, but did not turn blue. He had a fine pinpoint rash and swollen lips and under eyes.  He was given benedryl in ER and improved and sent home.
This is a spontaneous report based on the information received by Pfizer from Merck and Co., Inc. (Case Number: 00811688). A contactable Nurse reported for a female patient that: Description: The primary reporter is Nurse (Nurse name). Nurse reports that on "07Feb2018" a patient was administered PREVNAR 13 (Company name) and experienced "Injection site erythema, pain and hives around her trunk". Patient was treated with "Prednisone" (Unknown manufacturer) for an unspecified amount of time. No further clarifying information provided. No additional information. Product: Product: PREVNAR; Product circular number: Unknown by reporter; Lot number: Unknown by reporter; Expiration date: Unknown by reporter; Dose/frequency: Unknown by reporter; Manufacturer (if available): (Company name). The information listed above is all data we have received. Please do not contact Merck and Co., Inc. for additional information. Any follow-up information received by Merck and Co., Inc. regarding this case will be forwarded to you upon receipt. No follow-up attempts possible. No further information expected.
Rec'd 1st Pfizer covid vaccine on 4/3/2021,8:30am. Within two minutes experienced extreme faintness, weakness, shakiness. Placed with paramedics approx 1 hr. Husband drove me home. Legs felt very heavy, face was numb. Called TeleHealth 2pm same day. Dr said "symptons not normal, go to ER". I waited because of ER expense. By 5pm same day, I felt better. However, for over two weeks I stayed in bed. Extreme fatigue and sudden bouts of faintness. Scary. Went to Urgent Care 4/13/21. Dr. said to go to ER for more tests or primary dr. Saw Dr. on 4/15/21. Labwork on 4/16/21. Labwork and tests good. BP has abnormally spiked since shot, but normal since 4/20/21. Dr said do not take 2nd vaccine
Shots given in AM, child left office with mom and fell asleep.  Child woke after 3 hours, mom then noticed 2x2 red, hard, warm swelling to area bilaterally and gave Tylenol and called us.  Came into office applied ice bilaterally, MD ordered Benadryl given and monitored for about 2 hours.  Swelling decreased, redness decreased, warmth decreased.  Follow up on 02/27/03: No redness, swelling-legs back to normal.
Extreme fatigue, been in bed for 2 days, from top of head to the middle of chest extreme pain, can't move neck,
ZOSTAVAX given 9/6/12 - patient noticed redness in arm with vesicular rash & fever 101.2 9/8/12 - redness has lessened now - patient seen in office 9/11/12 - has vesicular, red rash size of silver dollar now.
Erythema and flakey around nose and frhead.  Was not using 1% hydro-cortizone cream.  Started day 7 after vaccination worsening noted day 10 and 11.