chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain and palpitations, fatigue immediately post vaccine and chest pain starting 43 hours later. Admitted at 48 hours with troponin 20,000 and decreased biventricular function on echo (RVEF 37%) consistent with myocarditis. Symptomatic improvement post IVIG treatment. Hospital stay 4 days without arrhythmia or other events. Treated with IVIG alone.
Within 12 hours developed tiredness, muscle and joint pain.  No fever or nausea.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Get the shots, had shingles 9 months later/ suspected vaccination failure; Get the shots, had shingles 9 months later; This case was reported described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient had a shots, and experienced shingles 9 months later.  The patient was not able to work. This case was considered as suspected vaccination failure since the details time to onset and laboratory confirmation was not provided
Slight nausea lasting one day Light headedness lasting two days + Swelling in knee lasting one day
Pt c/o rash covering arms & legs with itching day of vaccine, followed by fevers/chills & +1 pitting edema.
WITHIN A MINUTE OR TWO OF THE VACCINATION, THERE WAS SWELLING AT THE INJECTION SITE-APPLIED ICE PACK FOR AROUND 20 MINUTES-PT STATED SHE WAS OK AND TOOK THE ICE PACK WITH HER FOR THE RIDE HOME-CALLED TO CHECK ON HER THE NEXT DAY
tiny itchy red bumps on BOTH arms /   appearing approximately 24 hrs after injection   /   still visible 48 hrs after injection    / treated with OTC antihistamine   /    No similar reaction to 2 previous doses
Lightheadedness following by persistent tachycardia with heart rate up to 137 and hypertensive BP readings up to 165/90, 152/105 with positive orthostatic pulse change from 116 sitting to 137 standing . Ox sat 98%.  Slightly increased work of breathing.  Paramedics called.
I had a respiratory  problem two weeks after I receiveddd the shot. I ended up in the emergency room overnight. Then two weeks after that I had no feeling in my right leg from the knee down. It is still numb five months later
Pt. reported feeling and SOB as per mum, pt had %. episode for a few second and regained consciousness. Pt also repeated muffled hearing vital signs: HR 98  SAT O2 90%. when rechecked, Sat O2 was 97%. pt was advised to lie flat in the car and was asked to a hydrated. pt. was given graham cracker.. Pt is not on any med, pt reported improvement in 5 to 10 minutes and advised to notify health care professional  of any worsening of symptom or if symptom is  not resolved. Pt left the site with parent
Sore Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm Injection Site). On 23-Jan-2021, VACCINATION SITE PAIN (Sore Arm Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm Injection Site). On 23-Jan-2021, VACCINATION SITE PAIN (Sore Arm Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
8 hrs. after vax., had papular rash on trunk and small amt. on head, slightly itchy. Few papules/painful on 2nd day. No vesicles. No other sx's. Mostly gone after 1 week.
When I got to the car my face felt hot and flushed, but went away. then about 45 mins later I felt dizzy and my feet, hands and tongue  were tingling . I kept having dizzy feeling and light headed. The next day I felt nauseated and had blurry vision with not tingling in hands or feet. I felt Anxious and my heart was vibrating, I still felt light head and would have dizzy spells. On the 3rd day after the vaccination I felt like I was having a hard time breathing.
headache; Shortness of breath; Chest pain; Difficulty breathing; Heart palpitations; Aches; Extreme fatigue/fatigue; This is a spontaneous report received from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch ER2613), via an unspecified route of administration in left arm on 19Mar2021 09:45 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Medical history: hodgkins lymphoma survivor (1996), splenectomy. Concomitant medication was not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The patient experienced extreme fatigue on 19Mar2021 at 07:00 PM, aches on 20Mar2021, chest pain, difficulty breathing and heart palpitations on 22Mar2021, first episode of shortness of breath and headache on 24Mar2021. The patient assessed events as non-serious. Treatment received for the adverse event was unknown. Test Name: RT-PCR. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021.  The patient was recovered from the event headache where not recovered from the events extreme fatigue, aches, chest pain, difficulty breathing, heart palpitations and first episode of shortness of breath.
Patient tested positive for COVID 3/31/21. Completed COVID vaccine series 1/27/21. Onset of congestion 3/30/21.
Within 24 hours ears felt stopped up but some sounds were roaring. Difficulty hearing others talk.  Still having problems but it is improving slowly. This happened after 1st vaccine and lasted for about a week. I just didn?t link it to the vaccine until the experience returned after the second dose.
Pt recvd 1st dose of Hep B vax on 20NOV91 & exp a flare-up of shingles, sore arm/local rxn & a systemic rxn; No further details were provided;
Flu shot given 5NOV; 12NOV ache all over-stomach pain & gas, h/a & fever; temp not taken;
THE INDIVIDUAL RECEIVED LESS THAN 0.5 ML OF THE JNJ VACCINE AS THE INITIAL DOSE (APPROXIMATELY AROUND 0.3 ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced the individual received less than 0.5 ml of the JNJ vaccine as the initial dose (approximately around 0.3 ml). On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5 ml of the JNJ vaccine as the initial dose (approximately around 0.3 ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210112 and 20211210197.
This spontaneous report was received from a medical assistant regarding a female patient of unknown age. Approximately on an unknown date in 2012, the patient was vaccinated with first dose of GARDASIL (Lot number, expiry date, dose, route and frequency not specified). The second dose of the vaccine was taken on an unspecified date in 2012. The third dose of GARDASIL was supposed to be taken in December 2012, but the patient did not receive the third dose within specified time (outside the recommended dosing schedule) and was in the office to receive the third dose. No product quality issue was noted. Additional information has been requested.
AMNESIA; CHEST PAIN; SPEECH DISABILITY; ARM PAIN; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced amnesia. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced speech disability. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, amnesia, chest pain, speech disability and headache was not reported. This report was non-serious.
developed Bell's Palsy of left face, also on 2-22-21 she had an episode of feeling weak
Patient states that a knot and bruise formed at the injection site. The area between the elbow and deltoid (below injection site) became swollen, red, and inflamed.
Information has been received from a medical assistant concerning a 20 year old female patient who on 22-MAY-2012 was vaccinated IM with a first 0.5 ml dose of GARDASIL suspension (lot # 672232/1495AA Exp 22-AUG-2014). On 22-MAY-2012 the patient who had received her first dose of GARDASIL sat down for 10-15 minutes after receiving the injection, started walking towards the door when her legs gave out. The patient did not receive any treatment or seek any medical attention. AE improved on therapy and on 22-MAY-2012, the patient recovered from the event. Follow-up information has been received from health professional concerning a 20 year old female patient with no illness at the time of vaccination. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 22-MAY-2012 at 16:55 PM, the patient went to check out and passed out. Patient fell against wall. The physician was notified and vitals taken. The patient was given a glass of water. It was reported that the patient was assessed again and allowed to go home. No laboratory diagnostics tests were performed. The patient's outcome was recovered on 22-MAY-2012. The relatedness the patient's events was not reported for GARDASIL. Upon internal review, passed out was considered to be other important medical event. Additional information is not expected.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact
pt recv vax 3MAR97 & devel swelling of lt arm on 5MAR97;pt was treated w/ice packs & the swelling subsided;
Information has been received from a physician concerning a 5 year old male with no medical history or allergies who on 16-FEB-2009 was vaccinated SC in the right arm with the first dose of VARIVAX (Merck) (lot # 659601/1909U). There was no concomitant medication. The patient was not ill at the time of vaccination and had no prior reactions to prior vaccinations. On 03-MAR-2009 the patient developed 12 to 18 varicella like lesions on the left lower abdomen with erythema and fever. It required a doctor visit and the patient recovered from the symptoms on 06-MAR-2009. Additional information is not expected.
Patient received influenza and Pneumovax. Influenza was tolerated well with no bleeding in left arm. Upon receipt of Pneumovax in right arm, significant bleeding occurred, and patient's tissue at site of injection almost had the texture of becoming fibrous and hard on palpitation. Patient was asked to stay in the pharmacy for 15 more minutes, at which time the swelling and fibrous nature of the site resolved significantly.
Per patient complaint of bruises w/black marks, and swelling on 10/10/2014 PM, on 10/11/2014 per pt took "old clindamycin found at home".
Nausea and diarrhea (12 hours after injection, quickly resolved) , fever, chills and  body aches (13 hours after injection, gradually improved 2-3 days after injection), pain at injection site (immediately after injection, slowly  diminishing 4 days after injection).
Given quadracel and proquad as part of 5 year well visit. (1st time for proquad, had MMR and Varicella) Within a few minutes, patient developed an urticarial rash on his left arm and spreading to his chest. No trouble breathing or wheezing. No facial or tongue swelling. Was given Benadryl and monitored in the office for 30 minutes.
Can't breath; Rash; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Can't breath) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Can't breath) and RASH (Rash). At the time of the report, DYSPNOEA (Can't breath) and RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were provided. It was reported that reporter saw a study that a women gotten a moderna reaction that could not breath and rash. The study said they could not figured out why the women had a reaction. No treatment information was reported. Reporter did not allow further contact
I did not present any allergic reactions until 11 days after my initial vaccination, which seems extremely odd.  I was expecting to see something shortly after receiving the vaccine.  I did take pictures.  Around the injection site, it looked like hives and definitely continued to get larger in the proceeding couple of days.  I contacted my doctor via email and asked about this.  I put ice on the injection site.  And, I already take allergy meds, so that should help.  I took 3 rounds of Benadryl for 2 days.  You can still see a ring around the area, but the hives seem to be gone.
vial was out of the fridge for 24 hours post puncture; Dose administered more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial was out of the fridge for 24 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was out of the fridge for 24 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial was out of the fridge for 24 hours post puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided.  On 22-Apr-2022, the vial was initially stored in the refrigerator. On 28-Apr-2022 at 7:30 AM, the vial was first punctured. The vial was stored at room temperature post puncture and exposed to room temperature range of 8 to 25 degree Celsius = 46-to-77-degree Fahrenheit for 27-28 Hours. Later on, 29-Apr-2022 at 10:30-11:00 AM, the vaccine was administered.  It was reported that, the vial did not undergo any temperature excursions.  No treatment information was provided.
It was reported that an 18 year old female pt received Menomune on 9/9/03. The next day, on 9/10/03, the pt developed a local reaction at the site, as well as headache, body aches and fatigue. The pt was seen by a physician on 9/12/03. Reportedly, the symptoms resolved on an unspecified date and the pt recovered.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jul2023 as dose number 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; levothyroxine (LEVOTHYROXINE), since 01Jan2016 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events:  Patient received COVID 19 anti viral treatment with Paxlovid form 01Oct2023 to 05Oct2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient with fever, pain in arm where pneumococcal vaccine injection was administered subcutaneously.
tested positive for covid twice; tested positive for covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. The patient (wife) stated she and husband both tested positive for covid twice even though they have taken precautions and have taken shots as they become available. Both times husband ended up with symptoms much less than the patient. She believe that it is possible that one or more of the heart meds he takes may have lessened his response as compared to her.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300074311 same reporter/drug, different patient;
In Oct90 10 out of 59 pts were found to have insuff or neg antibody levels during testing for anti- HBS.  (see EBU910168 - EBU910171 - EBU910173 - EBU910177)
Bad Chills; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Bad Chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (Bad Chills), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, CHILLS (Bad Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.
Fever of 101.8. Excessive and inconsolable crying for 7 hours straight. Irritability. Coughing. Spit up/vomiting.
March 19 day of shot sore arm,some aches.   March 22 severe tinnitus in both ears,face cheeks hot to touch...kMarch 26 tinnitus was better,March 28 severe tinnitus back..
Patient passed became light headed immediately following vaccination. We attempted to distract the patient by talking. He passed out approximately 5 minutes after vaccination. His eyes rolled back into his head, he passed out, and twitched a few time. He was unconscious for less than a minute. He was disoriented when he woke up and sweaty.  After a few minutes he became less disoriented.  Emergency was contacted and patient was oriented and feeling much better by the time they arrived. They monitored vitals, which were normal.  Patient was released to go home about 40 minutes after incident.