chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious unlabeled spontaneous report of right arm pain has been received from a health care worker concerning a nine-year-old female, subsequent to receiving FLUMIST. No past medical history or concomitant medications were reported. The patient received FLUMIST on 21-Nov-2007, nasally for influenza prevention. On 20-Dec-2007, the patient came to her physician's office with right arm pain so severe she would not allow anyone to touch her. The patient was referred to Orthopedic and neurology specialists; she was treated with orapred for 5 days, diphenhydramine, TYLENOL no. 3 and ALEVE. Around the same period of time the patient had a dodge ball injury in gym and her arm pain was attributed to the gym injury. The arm pain resolved on an unknown date.
12/24/2021 Fatigue  12/30/2021 pain in chest in back and burning under sternia ; call the doctors office and referred to emergency room, went to ER two EKG in chest one at beginning the another two hours later when she was having the same feeling in chest prior to going to the hospital,  Premature Atrial Complexes,  CTscan of lungs for blood clots and it was negative for clots. scan , saw scans showed pulmonary noggles and mucus plugging of the brocueous started Dixycycline 12/31/2021 . Set-up a necluar stress test for heart on 01/07/2022. Primary physician on 01/20/2022,  recommended ECO cardiogram and  lack of energy with shortness and breath 01/31/2021 ECO cardiogram found out that she, wanted to know the heart function and had leaking heart valve and was not concerned about ECO cardiogram.  Can past your self at home with cores but when she is out and about with shortness of breath and she is wearing theNn95 mask.  Pulmonary is 02/17/2022 CTscans are coming up for her lungs.
dizziness; vomiting; queasiness; This spontaneous report was received from a pharmacist and refers to a 17 year old female patient. The patient did not have any known allergy, medical history or concomitant medications. On 24-JUL-2019, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) route intramuscular for prophylaxis(lot # and expiration date were not provided). Subsequently, the patient developed dizziness, queasiness with vomiting. No treatment was administered for the adverse event and all symptoms resolved within about 15 minutes with no further sequelae. The reporter did not provide the causality assessment between the aforementioned events and therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).
Patient collapsed following administration of ADACEL vaccine.  He became pale, cold, and was temporarily unconscious.  He came to right away.  We then had him sitting until EMT came where they administered O2.  He did not receive any other treatment at the time.  He was then escorted to the nearest ER.
On Saturday, November 13th, twelve and a half days after the Moderna booster, I noticed a rash. At first, I thought my whole chin was breaking out in acne (uncommon for me, even during adolescence) and applied benzoyl peroxide cream. The next morning (Sunday), I had a rash behind both ears and extending down the sides of my neck, just above my eyes in the center of my forehead, and covering my chin below my mouth.  The rash was small raised pink bumps, without pustules and slightly uncomfortable but not aggressively itchy.   On Monday I contacted my primary care physician by email, including photos of the rash. His office arranged for me to see my dermatologist the next day (Tuesday). She thought it was inconsistent with a food allergy, diagnosed it as periorificial dermatitis and took a small biopsy behind my right ear.  The biopsy reported spongiform tissue, consistent with a hypersensitivity reaction.  The rash faded fairly quickly but was followed by a small cold sore on Thursday, November 18th, which then turned into a full mouth reaction of cracked lips and discomfort that is very slowly receding but still not completely resolved. I don't know whether this is also a reaction to the vaccination or if it is a result of my immune system being challenged as I sometimes get a MUCH milder version of this condition after having some kind of systemic infection.
A few hours later that client experienced pain, severe itching at the site of injection as well as a red blotch around the site.   This lasted for about 3-4 days.
Tachycardia with heart rates 100-160 for periods of 10-20 minutes intermittently for 2 months post vaccination.  Primary MD made aware.  EKG obtained.  MD reported he would suggest followup with specialist if symptoms persisted.  Tachycardia stopped after 2 months.
Patient appeared to be having a seizure for a short time (estimated to be less than a minute) after receiving his vaccines.  The adverse event happened about a minute after receiving the vaccines.  Upon awakening the patient felt normal other than having a small headache and possibly some difficulty breathing.  Paramedics arrived and the patient's mother elected to have him taken to the ER for more evaluation.
lymphocyte count was 22 and now it is 14.7; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOPENIA (lymphocyte count was 22 and now it is 14.7) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 LYMPHOPENIA (lymphocyte count was 22 and now it is 14.7). At the time of the report, LYMPHOPENIA (lymphocyte count was 22 and now it is 14.7) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No energy for 8-9 days, right side of brain has pressure for 10 seconds at a time, 4-5 times a day.
5.5 x 6 cm round reddened, firm area on upper right thigh, warm to touch, but not hot. Pediarix given, was DTaP #3.
Apprx. 06/01/2005  (lost paperwork) I presented myself at emergency with an abscess/staph infection in my right thigh area. (this being the third such infection requiring hospital treatment in the last 24 months.)(left forearm, right thigh, right buttock....and now left hand.) After lancing and draining I was asked if I wanted a Tetanus booster previously I had refused the booster but today I was getting quite concerned about repeticious nature of these staph infections so I asked for the tetanus booster. Approx. 12 hours after leaving the hospital I had what I would term a physical meltdown. My system was bouncing from cold sweats to high fever and I was unable to move except for to sleep. almost 18 hours later after remembering that I had some Benedryl and taking them I finally was able to stand...feed myself...etc. My memory of the details of those 18 hours is foggy. However I can tell you without doubt there was a point that I felt certain I wasnt going to live. I did not report the incident until my visit yesterday to emergency.....for another staph infection that in 24 hours had my left hand near bursting from swelling.
Passing out, heart flip flops, tachycardia, high blood pressure, excessive sweats, tingling and cold in hands and feet, chest pain, dizziness, weird scary head pressure, flushing and then extreme paleness, exhaustion
On day 2 post vaccine I began my period early with abnormal bleeding. That lasted approximately two days then stopped. On the morning of September 13, 2021 I began noticing I was having difficulty breathing and felt nauseous. Shortly after I started to experience severe pain in the left side of my chest and side, pain down my left arm and up the left side of my neck. My heart rate and BP were both also elevated and remained elevated throughout my time in the emergency department. They connected me to an EKG and took initial blood work. At the ER my EKG results showed left atrial enlargement. The doctor asked a series of questions about recent life experiences that could have triggered this response. When he asked if and when I had received the vaccine he immediately ran additional tests (X-ray and blood work). My blood work came back negative for blood clots and explained I was experiencing inflammation of the heart or sack surrounding it. He discharged me and told me to take anti-inflammatory meds. If symptoms worsened to come back. He also suggested I follow up with my PCP. No discharge paperwork was provided.
itching; rash; I started itching bad, it continued t get worse so I went the dr. I was told to take antihistamines. The rash continues to get worse; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program.  A patient of an unspecified gender and age received bnt162b2 (PFIZER-BIONTECH COVID-9 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. The patient received the 2nd dose of covid vaccine on the 28th and 2 days later the patient started itching bad, it continued to get worse so the patient went the doctor. The patient was told to take antihistamines and the rash continues to get worse but the antihistamines help temporally. The outcome of the events was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Fever.    Headache    Severe chills.   Achy all over No energy  Off and on headache
Post vax, the pt developed autistic features. Treated with early childhood intervention, speech therapy, sensory therapy.
All day on May 5, 2021: achiness and soreness at and around the injection site, chills, no fever, loose bowels, overall body aches, fatigue
approx 2 hrs p/vax pt became lethargic, t102.5 taken to MD temp elevated to 104.5-referred to hosp the next day & hospitalized over nite for temp & vomiting;
Knee joint pain; Elbow joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee joint pain) and ARTHRALGIA (Elbow joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 724- 627-8874) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (Knee joint pain) and ARTHRALGIA (Elbow joint pain). At the time of the report, ARTHRALGIA (Knee joint pain) and ARTHRALGIA (Elbow joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-079951 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079951:Dose 2
Initial report received from a health authority on 05 Jan 2010: This child patient was vaccinated with pandemic (H1N1) influenza virus vaccine (manufacturer unknown) on 29 Dec 2009. On 30 Dec 2009 the patient presented with chickenpox. No outcome was reported for the event.
She came in wanting the covid vaccine and 2 techs and myself asked her the questions. She did not have a fever or ever say she had covid after getting the vaccine she stated she was in the hospital last week with covid and had the monoclonal antibodies treatment.
Feeling so cold; Extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling so cold) and CHILLS (Extreme chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING COLD (Feeling so cold) and CHILLS (Extreme chills). At the time of the report, FEELING COLD (Feeling so cold) and CHILLS (Extreme chills) outcome was unknown.            No concomitant medication was reported No treatment medication was reported  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-015590, MOD-2021-015590 (Patient Link).
Bivalent dose was given prior to completion of primary series. Pt is receiving primary dose ASAP and will receive booster later.
Information has been received from a consumer concerning her 85 year old husband with allergy to aspirin and ACULAR and a history of colon cancer who on 22-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ACTONEL, LIPITOR and number of other medicines (unspecified). On 22-OCT-2007 the patient developed a rash on his abdomen, on back and on top of his feet and ankles. There were total of approximately 40 red welts on patient's body and it caused lot of itching. The patient took BENADRYL and had a dexamethazone injection. The rash lasted for 2 weeks. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/26/208.  Information has been received from a consumer concerning her 85 year old husband with allergy to ASPIRIN and ACULAR and a history of colon cancer who on 22-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Merck).  Concomitant therapy included ACTONEL, LIPITOR and number of other medicines (unspecified).  On 22-OCT-2007 the patient developed a rash on his abdomen, on back and on top of his feet and ankles.  There were totatl of approximately 40 red welts on patient's body and it caused lot of itching.  The patient took BENADRYL and had a dexamethasone injection.  The rash lasted for 2 weeks.  At the time of report the patient had recovered.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Follow-up information was received from a certified medical assistant.  This 86 year old female withi allergies to ASPIRIN, ACULAR and SULFA, COPD, hypercholesterolemia and a history of prostate cancer and colon cancer was vaccinated IM in the right arm on 23-OCT-2007 (previously reported as 22-OCT-2007) with a dose of ZOSTAVAX (Merck) (lot # "08866").  There was no illness at the time of vaccination.  At 10:00 a.m. on 24-OCT-2007 (previously reported as 22-OCT-2007) the patient had an unrticarial eruption on his torso, ankle and thigh, the patient was noted to be very pruritic and uncomfortable.  Unspecified medical attention was sought.  The patient's reaction lasted 4-5 days (previously reported as 2 weeks).  The patient was reportedly recovered.  Additional information is not expected.  This is in follow-up to report(s) previously submitted on 3/26/2008; 6/24/2008. Follow up information was from the consumer who wanted to know if there was a greater chance of the vaccine not working because of the adverse event. She provided no additional adverse event information regarding her husband's experience. Additional information is not expected.
lower lip began to swell; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 14:45 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: Other medical history: asthma; "copd" (unspecified if ongoing), notes: Other medical history: copd; "hypo thyroid: Hypothyroidism" (unspecified if ongoing), notes: Other medical history: hypo thyroid; "sulfa drugs" (unspecified if ongoing); "Egg" (unspecified if ongoing), notes: Known allergies: Egg. Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE]; ALBUTEROL [SALBUTAMOL SULFATE]. Past drug history included: Propolis for Known allergies: propolis, notes: Known allergies: propolis; Albumen for Known allergies: Albumen, notes: Known allergies: Albumen; Balsam of peru for Known allergies: balsam of peru, notes: Known allergies: balsam of peru. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 23Jan2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 14:45, outcome "unknown", described as "Booster dose"; LIP SWELLING (non-serious) with onset 08Dec2021 15:45, outcome "recovering", described as "lower lip began to swell". Therapeutic measures were not taken as a result of lip swelling.  Additional information: There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient took his daily Zyrtec for environmental allergies and that was 4 hours prior to vaccine. He started complaining at 12:22 am on May 15, 2021 (13 hours after vaccine of a slight headache. We did not have Tylenol so gave him 4 chewable aspirins. Shortly after taking the aspirins, i.e. 20 minutes he started having involuntarily muscle tremors in his legs. I gave him 20 ml of Benadryl at 1:04 am and by 1:16 the tremors stopped and he told us that he felt completely fine. He slept soundly after the Benadryl. I think he is allergic to aspirin as he has never had it before.
running nose; possible sore throat; Cold; coughing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (running nose), OROPHARYNGEAL PAIN (possible sore throat), NASOPHARYNGITIS (Cold) and COUGH (coughing) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced RHINORRHOEA (running nose), OROPHARYNGEAL PAIN (possible sore throat), NASOPHARYNGITIS (Cold) and COUGH (coughing). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (running nose), OROPHARYNGEAL PAIN (possible sore throat), NASOPHARYNGITIS (Cold) and COUGH (coughing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
MENACTRA was given to a 17 year old by mistake/no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00387387) and transmitted to Sanofi on 09-Dec-2020.    This case involves a 17-year old male patient who received MENACTRA vaccine old by mistake of  suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U67878AA via intramuscular route in the left arm. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Concomitant medications included INFLUENZA VACCINE (FLU VACCINE VII).  This was an actual medication error case due to 3rd dose of Menactra after only a year after receiving the 2nd dose (Wrong vaccine administered). (latency same day).   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Not able to walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 (Lot number: EN6207) at the age of 73 years as dose 1, single and administered in arm left, administration date 16Apr2021 (Lot number: FWC153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "she broke her left femur", start date: 28Mar2020 (unspecified if ongoing); "She had Transgender surgery 20 years ago" (unspecified if ongoing), notes: She had Transgender surgery 20 years ago.; "epilepsy" (unspecified if ongoing), notes: She has epilepsy and has not had a seizure in 40 years; "glasses" (unspecified if ongoing), notes: When reading her vaccine card/needed to get on her glasses. There were no concomitant medications. Past drug history included: Baby aspirin; Centrum silver. Vaccination history included: Flu vaccine (prior to the first administration date of the suspect vaccine(s) was Flu vaccine dated unknown.  ), for Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 20Mar2021 11:00, outcome "not recovered", described as "Not able to walk".  Additional information: When reading her vaccine card, she stated she needed to get on her glasses. When you wear contacts, they give you one for distance and one for closeness. When you have cataracts, they give you both. This was all before the vaccine. The last 12 years of working were with University, and she put in 8-12 miles a night and worked 5 nights a week. She reiterated it was only noticeable after she got the injection and it could be for other reasons. Just prior in Jan or Feb2021, he felt really sick and crawled to the bathroom and threw up and walked downstairs and called for an ambulance. This occurred prior to vaccine. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was Flu vaccine dated unknown.  No follow-up attempts are possible. No further information is expected.
Hospitalization for unrelated event, testing found on discharge from Hospital, admitted to a different hospital.
Throat tightness  High fever to 102.5 for three days Severe fatigue  Severe swelling and redness with increased warmth at right arm injection site, with severe itching that persisted for two weeks. The swelling was at least  the size of a softball at injection site.