chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6204), administration date: 11Mar2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8733), administration date: 31Mar2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: EW0172), administration date: 15Nov2021, when the patient was 75-year-old, for Covid-19 immunization, reaction(s): "Sore arm"; flu shot (.), administration date: 26Oct2021, for Immunization, reaction(s): "Sore arm".  Additional information: It was reported that she had no problems with the first 4 doses, there was a bit of sore arm. No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room and physician office. The patient did not receive other vaccines within four weeks prior to COVID vaccine . The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241797 same reporter/patient/AE, different dose;
Uncontrollable arm seizures/spasms.  Last anywhere from 5-20 seconds each.  Began in upper arm.  Muscles tightened and lost control of motor skills and muscles during tremors.  Dissipated after about an hour with a few mild events following that night.  Appeared better the next morning..albeit tired.  Same event occurs one week later on 11/23/2009 at 7:00 PM.  Returned to emergency room again.
Confusion, Dizziness, PT REPORTED FEELING LIGHTHEADED, MENTAL FOG APPROX 15 MINUTES AFTER VACCINE ADMINISTERED. OBSERVED FOR 15 MINUTES, THEN SET TO ED FOR FURTHER EVALUATION.  PT REPORTED FEELING LIGHTHEADED WITH MENTAL FOG/MEMORY LOSS 15 MINUTES AFTER VACCINE ADMINISTRATION. SYMPTOMS DID NO IMPROVE, SO PT SENT TO ED FOR FURTHER OBSERVATION/ASSESSMENT
the patient (female) who received 1st dose was exposed to COVID; A spontaneous report was received from a pharmacist concerning a 47 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient (female) who received 1st dose was exposed to covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch: Not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient who received 1st dose was exposed to COVID. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of event patient (female) who received 1st dose was exposed to covid was not reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GAD" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Rebound of COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information:  The patient had COVID 19 Treatment Paxlovid, from 19Jul2022, to 23Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
He has a cold with stuffiness and cough; He has a cold with stuffiness and cough; He has a cold with stuffiness and cough; This is a spontaneous report from a non-contactable consumer (mother of the patient) from a Pfizer-sponsored program Customer Service Line.  A male patient of an unspecified age received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a cold with stuffiness and cough on an unspecified date when he was scheduled to get his second dose of meningococcal group b rlp2086. The mother wanted to know if he can still have the injection. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (also experienced chills and pain, refer the case for 1st dose US2018107211). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad, pain, fever, headache and muscle pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the feeling bad, pain, fever, headache and muscle pain were unknown. It was unknown if the reporter considered the feeling bad, pain, fever, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient had awful reactions and again had fever, aches, headache, and muscle pain. The patient had the same side effects. The patient was in bed all day but feel like turned the corner. This was 1 of 2 cases, reported by the same reporter for same patient.
Began having Post Menopausal bleeding on May 10, 2021.  Saw the doctor .  She did an endometrial biopsy that came back abnormal.  Then had a D&C on 6/2/2021.  The results were negative for Cancer.
Developed rash and swelling day after.  Become worse since then.  Saw provider - thinking could be cellulitis.
Patient reported sharp pain in her shoulder joint area, moving outwards. she is also having difficulty lifting her arm.
Developed shingles on the 3rd week after getting the first shot; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on an unknown date in Apr2021 at 14:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had other unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient developed shingles on the 3rd week after getting the first shot. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event developed shingles on the 3rd week after getting the first shot was resolving at the time of reporting.
A patient was administered PROQUAC on 09-JUN-2021. On 16-OCT-2021 the patient started to have a rash. The patient was taken to the doctor's office today (18-OCT-2021) and was diagnosed with chickenpox.; This spontaneous report has been received from a physician concerning a 16-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 09-JUN-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) reconstituted with sterile diluent, as prophylaxis (lot number T003714 has been verified to be a valid number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, expiration date 29-JUL-2021) (lot number T003714 is an invalid lot number for sterile diluent) (strength, dose, route of administration, and anatomical location of vaccination were not provided).  On 16-OCT-2021, the patient experienced a rash; she was taken to the physician's office on 18-OCT-2021 (also reported as today) and was diagnosed with chickenpox (varicella post vaccine). The patient received diphenhydramine hydrochloride (BENADRYL) as treatment for the event. No laboratory or diagnostic studies were performed. At the reporting time, the patient had not recovered from varicella post vaccine.  The causality assessment between the suspect vaccine, the sterile diluent and the event was not provided.  As of 19-OCT-2021, an attempt was made to reach the physician to confirm receipt of the  information that was faxed to him. The office administrator confirmed the receipt of the information, but she was unsure if the physician had reviewed it; she placed the physician on the phone and it was discussed the program information, including sample collection and shipping instructions. The physician was not sure if he would be submitting a sample, but he stated that he would review the information further and discuss with the patient's parents. The case number and phone number were provided in case he had additional questions or if he planned to submit a sample for polymerase chain reaction (PCR) testing through the program. No additional information was available.
Patient reported blurry vision shortly after vaccination while being monitored. No other side effects reported. Patient was monitored until symptoms eventually resolved.
COVID Vaccine breakthrough case. Vaccinated 5/4/21 EW0179, 5/25/21 EW0183. amd boosted on 2/10/22 FK9729.
Severe aching pain near injection area. Pain is so severe I can?t tell if  it?s in my shoulder joint or if it?s the muscle just below there m
Patient is a 14 year old male without significant past medical history presenting with chest pain and elevated troponin consistent with myocarditis after second COVID vaccine administration. His troponin level peaked at 4.0 mg/mL. Chest pain resolved prior to discharge.  ECG and Echocardiogram results below, both overall unremarkable.
On 10/20/2000, within a few hours following vaccination, evidence of pruritus was observed. On 10/21/2000, the patient developed dime-sized lesions on her inner thighs, which spread to her arms and chest and were worse in the morning. Subsequently, there were more than 50 lesions throughout the patient's body; one area broke out and resolved and then the lesions were found in another area. The patient was seen twice since the vaccination and 2 physicians did not feel that this was varicella, but was another virus. The patient's lesions and head cold persisted. Additional information has been requested.
Patient reports deep, sharp pain at site of injection.  Chronic x 2 months, intermittent. No visable signs of infection, no TTP.
Flu vaccine administered at 10:00 AM.  Headache at 10:05 AM.  Vertigo at 11:15 AM.
Early mental cycle not typical and early by 2weeks. Sharp pain in outer legs.  Headaches.  Fatigue.
On 3/8/2021, the patient presented to the ED after mechanical fall from ground-level and developed right hip pain. The patient was diagnosed with a closed right public fracture. Per EUA, all hospitalizations must be reported after receiving a vaccine. This hospitalization does not appear to be related to the vaccine.
arrives to the emergency department by POV presenting with a chief complaint of tachycardia onset today. The patient received his COVID vaccine this morning. He states that he does not feel ill, but the only way he can describe how he is feeling is "being lousy". He has had associated palpitations without feeling like his heart is pounding. He denies ever having COVID. He typically takes one baby Asprin per day, and his last dose was this morning.
I had cold symptoms like running nose, little cough, sneezing, and slight fever. I was on a cruise and they tested me for COVID-19 and I was positive. The doctor gave me cold medicine and antibodies.
shortness of breath; Fever; puffed face; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PYREXIA (Fever) and SWELLING FACE (puffed face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), PYREXIA (Fever) and SWELLING FACE (puffed face). At the time of the report, DYSPNOEA (shortness of breath), PYREXIA (Fever) and SWELLING FACE (puffed face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pain in front and back of my knees Pain on back of my Left elbow Left ankle swelling with burning pain Hard for me to walk Painful Bruising on both of my lower legs
Initial unsolicited report received from consumer on 20-Sep-2017. This case involves a 70-year-old female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (also reported as Fluzone High-Dose) (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on an unspecified date in Sep 2016. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced "the flu" which became bronchial pneumonia from Nov 2016, few month following the vaccination. It was reported that, the patient received FLUZONE HD in 1995 (reported as "19952"). Lab data was not reported. The patient received corrective treatment (unspecified). The patient's was recovered from the event on an unspecified date. Upon internal review, the company decided to consider the event serious because of important medical event broncho pneumonia. List of documents held by sender: none.; Sender's Comments: The patient experienced Broncho Pneumonia and flu like symptoms post vaccination with FLUZONE HD. Time to onset seems to be compatible and the event is unlisted with the vaccine. No information regarding patients medical history or concurrent medical condition has been provided. Broncho pneumonia could have n alternate etiolofy that should be investigated and ruled out before assessing the case. BAsed upon reported information the role of the vaccine can not be assessed.
Vertigo and tinitis in left ear The vertigo is getting better and is only noticeable when I first get up in the AM and with dramatic movement of my head, but it has lasted for a month and 18 days. But the tinitis continues.
After second vaccination became very nausea, arm is swollen. Arm currently still swollen, bruised, itchy and painful.
Information has been received from a woman concerning her friend who was vaccinated on an unknown date with a dose of Zostavax (Oka/Merck). Subsequently, the patient experienced a headache which lasted for 2 days and an injection site reaction. It was unknown if medical attention was sought. The patient recovered from the headache, but the outcome of the injection site reaction was unknown. No product quality complaint was involved. Additional information is not expected.
Body aches, right shoulder and armpit soreness,  right side of my ribs and right arm pain from shoulder going down to my fingers tip, and headache.
Pt had become increasingly short of breath over the last 2 days.  He had a history of cardiac and pulmonary disease.  He had newly diagnosed A. fib.  He was found to be COVID positive with possible secondary bacterial pneumonia.  Prior to admission he went into PEA arrest and was pronounced dead.
Had MMR 18APR92 & ON 26APR92 fever which lasted 4 1/2 days (101-103); a mild transient rash on face & neck & upper chest; no conjunctivitis; no koplik spots; t nl 30APR92; fine now;
Patient received Janssen COVID-19 vaccine at 123pm on 3/25/2021. Patient directed to observation area and fell backwards out of chair at 127pm on 3/25/2021. After falling backwards out of chair patient had a full body stiffening episode and was noted to be bleeding from his head. Bleeding controlled with gauze held by an RN. Patient initially GCS 13 and unable to answer questions appropriately, manual blood pressure 118/60 HR 50 SpO2 89% on room air, patient pale and dry. Patients legs raised by RN and pressure to laceration on top of forehead continued to be held by RN. After 5-7 minutes patient GCS increased to 15 and he was alert and oriented x 4, manual blood pressure 114/60 HR 62 SpO2 97% on room air, patient pink warm and dry. Fire arrived on scene at 147pm and Ambulance shortly after. Fire and Ambulance given report by RN on site while other RN on site continued holding pressure to laceration on forehead with gauze.
Systemic: Bell's Palsy-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: dad said he is having twitching and paralysis of facial muscles making it difficult for him to see
On March 31st, 2021 I received my first shot of the Moderna Vaccine, after testing negative following a 5 week session with Covid-19.  The results of the first shot was a violent reaction within 10 minutes of the vaccination.  Symptomes included;  tingling in my face, followed by the 2 extreme symptomes (numbing left ear and left neck spasming) that I experienced during my spell with the Covid-19 on January 5th 2021, I was diagnosed with Viral Pneumonia.    After vaccination, I was sent to the emergency room for treatment.  While waiting for the ER personnel to address my symptomes, I went numb from top of my head to my toes.  I told the nurse what happened and the medical staff came in and started treatment of (Benytrel, steroids by I.V. delivery.  I broke into a red rash from head-to-stomach.  The doctor administered Adrenaline to speed the medication effect.  I left the hospital 2.5 hours later, pink skin color instead of red.  The rash would come and go for 30 days. Because of the reaction I experienced.  I did not move forward with the 2nd shot in fear of another violent reaction.  So, I had a strong case of the Covid-19 without any breathing problems and had my first shot of Moderna vaccine.   What are my options to be fully protected against the New Delta variant?  My current age is 62. Please advise! Thanks
pt recvd 2nd dose of Engerix-B on 20AUG92 & 1 day later returned to MD w/tingling in ulnar distribution of ipsilateral arm; no weakness or objective neurological findings;
Baby presented for 9 month child health and was only due for a flu vaccine.  Staff administered 6 month vaccine schedule to 9 month who was up to date.  Baby received an extra pediarix, prevnar and rotovirus vaccine.  No adverse reactions noted.
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.  Patient has no side effects after receiving first dose of moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Non significant follow up:NNI
Onset of diarrhea: 3pm & 4pm; slight lightheadedness: 5pm; severe dehydration: 6pm; extreme lightheadedness & loss of appetite: 6:30; severe lower lower back muscle aches & onset of headache at the base of scull: 6:30; extreme spinal chord discomfort: 7pm; fever, severe muscle aches, headache, extreme skin sensitivity, sweating: 7:30pm to the following day. Still experiencing severe flu like symptoms as of 4:30pm on March 26.
pt states devel urticaria @9PM which progressed to diff breathing by 9:30 at which time pt went to ER where recv IV fluids & DPH;
Patient presented to the ED and was subsequently hospitalized for overdose, intentional self harm within 6 weeks of receiving COVID vaccination.
I had arm pain, lower back pain, but the most concerning is my body rash. I itch all over my body and parts of my skin are red and irritated. Little dots are starting to appear. My itching is on my scalp, neck, lower back,  butt, legs, and ankles. The red, irritated, itching rash did not occur immediately but did happen within the same day. I can not recall the exact time I started noticing the symptoms but the itching seems to be getting worse this evening (second day, evening)
2:15pm- Multiple ectopic contunious beets (100% pacemaker dependent), weakness, dizziness and confusion, 2:35pm violent shaking when supine, ~2:40pm received EPI pen by nurse while supine. ~2:50 EMT arrived and taken to the emergency room.
Pt had 1st covid vaccine 4/21/21, 2nd covid vaccine 5/13/21 in AM. 1.5 hours after her 2nd shot, she developed R sided rib/chest pain. Went to ER and found to have subacute pulmonary embolus on LEFT side of chest.
Pt got the shot on Friday. On Saturday, I woke up to an area on pt's right thigh swollen, hard, red, and hot to the touch. I wasn't too concerned because this happened with his PENTACEL shot too. On Sunday, I woke up to his whole upper thigh hard, more swollen, red and hot to the touch. We went to church and I asked a nurse there about it. He said they could have hit a blood vessel and to only be worried about infection if he developed a fever. He didn't have a fever. When we got home, he projectile vomited. I called the pediatrician, but it was a weekend so they weren't open. I contacted my paramedic friend who wasn't too concerned because pt was acting completely normal. He just said to watch for a fever as well. Pt never got a fever and continued to act normal. The next day his leg was a little better.