chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from physician concerning a patient who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot#656526/0284U). Subsequently, the patient developed a red, raised welt at the injection site. No further information was provided. There was n product quality complaint involved. This is one of several reports from the same source.
The initial COVID-19 symptoms I had were a high-grade fever, low oxygen saturation level slightly below 90%, congestion, muscle aches, and hot flashes; I was bedridden for about a week. I developed a cough where I wouldn't stop coughing to take a breath. It seemed like there was an obstruction causing difficulty to breathe. I took an at-home COVID-19 beginning on 01/01/2023 and every two days or so for two weeks which coming back positive. I called my doctor who prescribed me an Albuterol inhaler for my cough and Prednisone for my symptoms. I ended up being sick for about a month. I still feel some residual cough sometimes.
flare in dermatitis / rash got worse; face broke out in acne; arm and leg ache a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS ATOPIC (flare in dermatitis / rash got worse), ACNE (face broke out in acne) and MYALGIA (arm and leg ache a lot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis (had cleared up prior to the first dose of the Moderna COVID-19 vaccine on 20-Jan-2021.). Concomitant products included DOXYCYCLINE for Eye disorder NOS, LOSARTAN for Hypertension.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DERMATITIS ATOPIC (flare in dermatitis / rash got worse), ACNE (face broke out in acne) and MYALGIA (arm and leg ache a lot). At the time of the report, DERMATITIS ATOPIC (flare in dermatitis / rash got worse), ACNE (face broke out in acne) and MYALGIA (arm and leg ache a lot) outcome was unknown.            patient's lab test data not reported. Treatment for the events included an unspecified steroid shot and steroid cream.
Body aches; loss of appetite; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), dose 2 via an unspecified route of administration in left arm on 19May2021 13:45 (at the age of 21-years-old) as second dose, single for COVID-19 immunization. Medical history included COVID-19. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), dose 1 via an unspecified route of administration in left arm on 28Apr2021 13:45 as first dose, single for COVID-19 immunization. Prior to vaccination, the patient did not receive any vaccines within four weeks and was not pregnant. Concomitant medications included lorazepam, gabapentin, and mirtazapine. The patient experienced body aches, loss of appetite and tinnitus on 20May2021 12:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Hyperpyrexia to 104.7F. Possible febrile seizure witnessed by parents. Child stiffened, without shaking, arched her head back.
After injection, patient had flu-like symptoms with body aches, widespread pain, fever x 2 weeks.  After those two weeks patient developed pain and inflammation/swelling in multiple joints including hands, wrists, shoulders, knees, ankles, hips and feet.
Information has been received from an investigator during a study concerning a 71 year old male with hypothyroidism (since 2006), hypertension (since 2006), chronic obstructive pulmonary disease (2001), prediabetes (2007), ex-smoker and occasional drinker who did not use recreational or street drugs, who on 31-JAN-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 652936/0981F) at routine healthcare visit, including blood pressure and routine testing. Patient did not have concomitant vaccines. No complaints or concerns at this visit. Vitals on exam were within normal limits and on general exam patient was a well-developed, elderly, male, in no apparent distress, comfortable. Concomitant therapy included atenolol 50mg/d, therapy unspecified "LT4" 0.025mg/d and vardenafil 20mg/prn. On 25-FEB-2007 the patient presented at a facility and was noted as having a CVA and cardiac arrest. At this facility the patient had an EKG which was T-abnormal. The EKG impression included: QRS interval 89, QT interval 298, QT corrected 417, frontal axis initial -81, frontal axis mean QRS -77, frontal axis terminal -77, frontal axis ST 90, frontal axis T 85, left axis deviation, QRS axis -31 to -90; ventricular tachycardia, rate 118; since 2/4/05 VT now present. At the same day, the patient died. The cause of death was reported as cerebrovascular accident. At this time, relationship of CVA and cardiac arrest to study therapy is unknown. Upon internal review, cardiac arrest was determined to be an other important medical event. A lot check has been requested. This is one of several reports from the same source. Additional has been requested.   11/5/2008 Note received from FDA. Pt presented 2/25/07 and DX'd with CVA and cardiac arrest. 1/9/09-death certificate received-COD-Cardiac arrest.Ischemia of heart. Hypertension.
Inconsolable, thrashing tongue, arms unable to grasp, rapid hand movement.  Temp 100.4.  Pupils dilated.
p/vax pt exp a chickenpox like rash w/less than 20 pox;the rash was reported as mild;medical attention was sought;
Sore arm, nausea (throwing up), headache. Self treated at home with over the counter medications (tylenol & advil)
Patient experienced swelling halfway to his elbow, tingling and discomfort.  He was unable to lift his arm from the shoulder. Mobility limited to below his elbow.  Patient visited his PCP,  who recommended ice and Aspirin treatment for the next few days. Patient is to follow up with prescriber in 3 additional days.
Very weak; Cannot stand because she feels as if she was going to faint; feels as if she was going to faint, her sight turns black; Fatigued; Could barely sleep; Sore arm/body ache; Fever; Strong headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could barely sleep), ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and MYALGIA (Sore arm/body ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced INSOMNIA (Could barely sleep), PYREXIA (Fever) and HEADACHE (Strong headache). 21-Jun-2021, the patient experienced MYALGIA (Sore arm/body ache). On 22-Jun-2021, the patient experienced ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and FATIGUE (Fatigued). On 22-Jun-2021, INSOMNIA (Could barely sleep) and PYREXIA (Fever) had resolved. At the time of the report, ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and FATIGUE (Fatigued) outcome was unknown and MYALGIA (Sore arm/body ache) and HEADACHE (Strong headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In concomitant medications vitamins was reported.  Patient reported that she was told to take aleve and Tylenol as treatment.  At the time of reporting she did not take anything as treatment.
Sore arm/sore arm for a few days; Headache after a few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm/sore arm for a few days"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache after a few days". Additional information: The patient received both doses of the Pfizer-BioNTech Covid-19 Vaccine- 1st dose 04Mar2021 and 2nd dose was 18Mar2021. On the 1st dose she developed sore arm/ she had a sore arm for a few days and headache after a few days. On the 2nd dose she did not have any side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had abnormal blood work after my second vaccination. I had a feeling that something was off and decided to have the blood work done. I ended up having to get my thyroid medication upped.
Pt recvd 3 doses of Engerix-B & did not convert; recvd a 4th dose & no lab work was performed; scheduled for 25AMR92;
Patient received 2nd dose of Moderna COVID-19 vaccine on 21April and tested positive for COVID-19 on 24May via nasal swab.
Redness - Near Injection Site; Swelling - Near Injection Site; Lump/Hardness Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Lump/Hardness Near Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included JUNIPERUS COMMUNIS (DIURETIC [JUNIPERUS COMMUNIS]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Lump/Hardness Near Injection Site). At the time of the report, VACCINATION SITE INDURATION (Lump/Hardness Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Diuretic, Cholesterol Medication, LowDose Aspirin Treatment information was not provided.
She got the within minutes she asked me for water, all of sudden she passed out. I thought she was having a seizure they came over gave her smelling salts to revive her. She sat on the floor for 45 mins she was given orange juice to try to sit up. We was sent to the ER, came back normal on that Saturday. The next day she still felt as if she was going to faint. On Monday she went to school still having nausea, having difficulty eating. The morning of April 13, 2021, brought patient to hospital for dehydration, gave her 5 bags of fluid she stayed overnight, was diagnosed with a "gastro bug." Every since the vaccine she has episodes with her heart rate racing, lightheadedness and she has missed month of school. She is on medication to raise her blood pressure and has followed up with a cardiologist.
Patient returned for 2nd dose and reported that she had hives that started within 1 hour of her dose and lasted for 3 days despite taking Benadryl. Reports no shortness of breath occurred
Fever of 103. Febrile Seizure around 4:30 PM - seen in ER, advised to give Tylenol and Motrin as needed. Continued with fever until 3-31-19.
Initial complaint:  Feeling faint (holding head), both eyes starting to go black  1046  BP 110/70  HR 60  Said "feeling better"  did not eat breakfast.  Drank water and ae granola bar, vision improved. 1057  BP 115/72  HR 84  She stated she was feeling better after granola bar and water.
No additional AE reported; an expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S034299, expiration date 01-JUL-2021 (dose, route of administration and anatomical location were not reported) for prophylaxis. There had been no prior temperature excursion for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). There was no additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA006841: US-009507513-2107USA006618:
Patient ignored recommendation to wait in the waiting area after receiving the vaccination. Patient walked towards the front of the store and passed out in front of the photo counter at the front of the store. Patient came to on her own and proceeded to walk towards the front entrance and passed out a second time. Patient came to, was pale and shaking, Pharmacist administered Epi-pen and ambulance was called. When ambulance arrived Patient refused service.
196 patients received 0.25mL of Moderna Covid-19 Bivalent Vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Bivalent Vaccine).    Concomitant medication was not reported. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Age group added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:
Patient stated that she had aching joints. She received a tense headache and high fever. Patient also stated that she is experiencing extreme weight lost. Patient stated that she has lost 37 lbs. in 4 weeks or less.
I developed a headache on the afternoon of 4/5/21 around 4pm. Nothing too severe, but pain mostly in the back of my head. I went to bed around 10pm but awoke around midnight with body aches that kept me awake most of the night. They were mostly in my legs and hips. No fever at this time (temp was 97.7, close to my normal). I got up around 7am on 4/6/21, still achy but less so. The achiness was mostly in my hips. I showered but still felt achy and pretty tired. I laid back down around 11am and slept until 4pm. By then I was feeling much better, just a little groggy. No fever at any time. I felt back to normal by the next morning on 4/7/21.
This spontaneous report was received from a pharmacist refers to a 54 year old female patient. Patient's concurrent condition and medical history were not reported. On 15-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX vial , lot # K010630, expiration date on 30-OCT-2015 (dose, route of administration, anatomical location were not reported). When the patient received the dose of ZOSTAVAX, she also received FLUARIX (manufactured by GlaxoSmithKline) (strength, dose, anatomical location, route of administration, lot # an expiration date were not reported) at a different anatomic site. There was not concomitant medication reported. On 17-SEP-2015, the patient experienced an "apple-sized itchy rash" at the injection site. She had not sought any medical attention at this time. A product quality complain was not involved. At the time of the report, the outcome of "apple-sized itchy rash" was reported as not recovered. The relatedness of the adverse event and suspect therapy was not provided . Additional information has been requested.
Client called - states he got itchy all over and red in face after he sprayed some bug spray in the year 10-14-10 at about 2 PM. Took 2 BENADRYL and washed off. Felt better with no symptoms after 2 hrs. Has used that spray before without any probs.
At 3pm she felt flushed and tired. At 9pm was very hot and face was red, she then got shaking chills. By 10pm she had hot and cold flashes and stated that her heart was racing. This lasted until 2:30am on 9/29. She took her BP at home and it was 146/90 and the pulse read 92. She also had a headache. She took Tylenol on 9/29 at 12noon and then Advil at 3:30pm on 9/29 with relief of the headache. 9/30 she complaints of being tired and having a tight feeling in her chest.
flu-like symptoms; joint and muscle aches; muscle aches; overall malaise; pains; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, joint pain, muscle pain, malaise and pain. On an unknown date, the outcome of the influenza-like symptoms, joint pain, muscle pain, malaise and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, muscle pain, malaise and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had influenza-like symptoms, joint pain, muscle pain, malaise, pain and no fever. No further information was provided.
Pediatric dose (0.2ml) was drawn up from Adult Pfizer vial. 11 year-old patient received 0.2 ml of the 12+ Pfizer vaccine. The parent was notified at 5:31 pm on 12/3/21 that child was incorrectly given  0.2ml of adult Pfizer was discovered and told to monitor child for adverse effects.
About 5 minutes after receiving vaccine, patient reported experiencing dizziness and nausea. We continued to monitor the patient for about 20 more minutes while patient remained in seated position. Patient did not report any additional symptoms. We watched patient to ensure she did not faint or fall. Patient declined needing additional treament/attention. Patient's dizziness eventually resolved on its own. Patient remained in view of vaccination area for about 30 minutes post administration.
Rt deltoid swollen, red, tender, unable to move arm x2-3 months, used sling at home to prevent pain with movement - reported event/symptoms 9/2/08.
basically thought she had COVID all over again; basically thought she had COVID all over again; Pain at the injection site; Joint pain; Feeling unwell; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization.  Medical history included COVID a month ago in 2020.  There were no concomitant medications. The patient experienced pain at the injection site, headache, myalgia, joint pain, chills, nausea, feeling unwell, fatigue in Dec2020. The patient basically thought she had COVID all over again. The patient  stated, "I was calling because I just had the COVID vaccine which has caused so many adverse reactions which is the side effects? I am experiencing all the side effects but it is calming down because today is day three. Pain at the injection site, headache, myalgia, joint pain, fatigue, chills, nausea, feeling unwell. Basically I had COVID a month ago and I had vaccine three days ago (Dec2020) and I basically thought I have COVID all over again. I took the vaccine on Friday started with the symptoms pretty much on Saturday." The patient received ibuprofen (ADVIL) as treatment. The outcome of events was unknown. The physician assessed events pain at the injection site, headache, myalgia, chills, nausea, feeling unwell, fatigue was related with vaccine.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2  in this patient cannot be completely excluded.
Narrative:  Pt presented to the emergency department on 2/8/21 with complaints of itchy rash all over the skin after getting first dose of Pfizer COVID-19 vaccine on 1/29/2021. Denied difficulty swallowing or breathing, swelling of the lips/tongue/eyelids or swelling of the airway. Denied new soaps, detergents, colognes, lotions, fabric softeners, medications, foods or drinks. Generalized maculopapular rash with pruritus on BUE, BLE, torso, neck and face noted. Discharged from ED with prednisone taper and diphenhydramine and instructed not to get second dose of COVID-19 vaccine.
had DTP/OPV/HIB on 11JAN93 @ 430 @ 330 on 12JAN93 had red cheek (rt) then devel hives on rt arm-lt arm rt neck; called MD told give DPH;
This is a spontaneous report from a contactable consumer reported for herself that. A 93-years-old non-pregnant female elderly patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247), via an intramuscular route of administration at Right arm on 27Jan2021 12:00 PM at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, hiatal hernia, inguinal hernia and Allergies: shellfish. Concomitant medications reported as losartan potassium (LOSARTIN), levothyroxine sodium (SYNTHROID), omeprazole (PRILOSEC). On 03Feb2021 07:00 PM, Patient experienced Mild nausea. '3" on a scale of 1-10. No treatment received for the event. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient has not been tested COVID-19 before the vaccination. Seriousness of the case reported as non-serious. Patient has not been diagnosed before vaccination. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected