chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIZZINESS; FACE STARTED SWELLING FROM  EYELIDS AND LIPS.; TIREDNESS; HIGH FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, face started swelling from eyelids and lips., tiredness, high fever, nausea, and headache.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 deg/s. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and nausea, and the outcome of tiredness, high fever, headache and face started swelling from eyelids and lips. was not reported. This report was non-serious.
Rec'd vax 17DEC90 p/well child screen; Infant died on 19DEC90 mom reports giving acetaminophen every 6 hrs & that infant's fretfullness was not unusual or different fr her other children following immun; Cause of death SIDS;
03/30--- chills, headache,  febrile symptoms, and pain in the covid arm 03/31--- pain in covid arm and axillary swell (left), tenderness and itchiness in area of the shot.  04/01--pain in covid arm and axillary swell (left), tenderness and itchiness in area of the shot.  04/02--pain in covid arm and axillary swell (left), tenderness and itchiness in area of the shot.  04/03-- Redness and itchiness in area of the shot.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection (lot #, expiration date, dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit (also reported as more than 46 but less than 77 degrees Fahrenheit) for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012075:
On the eighth day after the first shot of vaccine, I noticed a red patch just below the injection.  It was about three inches by three inches.  I had itching but otherwise, no symptoms.  This am, which was the day after, I noticed that the patch had diminished in size but was still red.
This spontaneous report was received from a physician via a company representative refers to a 5 year old male patient. No medical history was reported. On 25-MAR-2013, the patient was vaccinated with a dose of M-M-R II (lot #, dose, route not reported) and (merck) VARIVAX (lot #, dose, route not reported). No concomitant medications were reported. On 26-MAR-2013, the patient began acting, possessed and crazy. No treatment was given. Patient sought medical attention (spoke to HCP on 26-MAR-2013). The outcome of the patient began acting, possessed and crazy was unknown. Additional information has been requested.
allergic reactions; mouth swelling; jaw swelling; Initial information received on 23-Nov-2021 regarding an unsolicited valid non-serious case from another health professional via (under reference 00870031).  This case involves a 67 years old male patient who had allergic reactions (hypersensitivity), which includes mouth swelling and jaw swelling (swelling face), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Tracheostomy.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 19-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ775AA and expiration date: 30-Jun-2022) via unknown route in an unknown administration site for prophylactic vaccination.  On 20-Nov-2021, the patient developed non-serious allergic reactions (hypersensitivity), which includes mouth swelling and jaw swelling (swelling face), one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "The caller is requesting the ingredients of FULZONE QUAD."  No laboratory data were reported.  He went to the Emergency Room (ER) and was treated with oral medication, he did not  know what the medication was.   He still had some swelling. It had not resolved completely (he did not recover from the reported events).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In 2013, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a physician's office, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2013, the patient was treated by a hospital (by an unspecified healthcare professional), for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Initial unsolicited report received from a consumer on 14-Nov-2017. This case involves a female patient of unknown age who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration, dose in series was not reported) on an unknown date 20 years ago. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient got dizzy. Lab data and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
2mins post vaccination pt c/o dizziness and vomiting. Vitals: 109/71, 97, 20, 100% Pt stable and released from the vaccination site @13:50.
pt devel urticaria 10 days following vax w/MMR; No further details were provided;
When I woke up in the morning I was sweaty and cold even though I had blankets on. I had body aches, joint pain, nausea, extreme fatigue to the point that I pretty much sat on my couch all day long zoning out, chills, and fever. Also pain at the injection site and couldn?t lift my arm.  The next day I was fatigued and my arm was sore at the injection site.
Information has been received from a pharmacist concerning a 23 year old female who on 08-FEB-2008 was vaccinated with her second dose of GARDASIL. The pharmacist reported on 12-FEB-2008, that the patient subsequently learned she was pregnant. The patient did not seek medical attention. No adverse reactions were reported. Follow-up information was received from a staff in the office and the registered pharmacist. The staff in the office reported that the patient had a tubal pregnancy in approximately February 2008 and "it had nothing to do with the GARDASIL". The registered pharmacist reported that she had received a request for the office for the third dose of GARDASIL for the patient in April 2008. The request note said that the patient was not pregnant at that time. The registered pharmacist had no any more information about the pregnancy. Upon internal review, tubal pregnancy was determined to be an other important medical event. No further information is available.
Patient who received first dose on 9/28/22 was unable to return to clinic until today; Case reference number US-BN-2022-004216 is a spontaneous case initially received on 20-Oct-2022 from health care professional via Communication (reference number: USBAV22-1745) and concerns a female patient of unknown age.  The patient's relevant medical history, allergies and concomitant medications were not provided.  On 28-Sep-2022, the patient was vaccinated with a first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown), at an unknown dose, unknown route of administration, at an unknown location, for pre-exposure prophylaxis for veterinary assisting classes.   As reported, the patient was unable to return to clinic in order to receive second dose of RabAvert in seven days (explicitly coded as 'Missed dose').  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received on 20-Oct-2022 included local case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert vaccine on 28-Sep-22. Dose, route and site of administration were unknown, but vaccine was administered for pre-exposure prophylaxis for veterinary assisting classes. Reportedly, the patient was unable to return to clinic in order to receive the second dose of RabAvert in seven days which is considered missed dose. The event is listed per the Company conventions. The patient's relevant medical history, allergies and concomitant medications were not provided. It was unknown if the patient experienced any adverse events. Missed dose is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert vaccine on 28-Sep-22. Dose, route and site of administration were unknown, but vaccine was administered for pre-exposure prophylaxis for veterinary assisting classes. Reportedly, the patient was unable to return to clinic in order to receive the second dose of RabAvert in seven days which is considered missed dose. The event is listed per the Company conventions. The patient's relevant medical history, allergies and concomitant medications were not provided. It was unknown if the patient experienced any adverse events. Missed dose is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
4 DAYS, 6 HRS. AFTER FLU VACCINE, I SUDDENLY HAD CHILLS AND SHIVERING. I WENT TO BED AND FELL ASLEEP; WOKE UP IN THE MIDDLE OF THE NIGHT FEELING HOT AND HAD STIFF AND TIRED MUSCLES. AT THIS TIME, I TOOK MY TEMPERATURE AND FOUND IT TO BE 101.5.  I STAYED IN BED FOR A TOTAL OF 19 HRS. AT WHICH TIME MY TEMPERATURE WAS 99.  AFTER GETTING UP I FELT PRETTY MUCH NORMAL BUT I STILL HAD STIFF MUSCLES, A LIGHT HEAD AND SHOOTING PAINS IN MY HEAD, EARS. AND FACE.  WHILE IN BED I WAS ASLEEP NEARLY THE ENTIRE TIME.  AT HIS TIME (ABOUT 40 HRS. AFTER THE INITIAL CHILLS) I FEEL NORMAL.
Started with strong itchiness (8 on a scale of 10) 7 days after 1st dose on the area where the dose was administered (right arm). Then the area became red and thick and started expanding a little over the days. This lasted for 5 days and disappeared. I took anti-histaminic starting on the 2nd day with those symptoms, it alleviated the symptom of itchiness. I had the second dose on the same arm and had none of the same adverse effects (just fever and tiredness).
On 2/7 I woke up with pain in left shoulder. Movement away from body caused intense tearing pain in shoulder and bicep muscle. After 4 days intense pain had subsided. I am still experiencing persistent aching in shoulder upon movement away from body and noticed marked weakness in arm upon exercise.
1st Dose - exactly one week after my shot (7 days) my left arm that was injected started to feel sore and swell. It itched real bad and turned red. The irritation started to spread down to my lower arm below my elbow. It hurt like if I had worked it out with heavy weights and the hurt tired feeling was felt to my bone. It was very uncomfortable. I took Benadryl and Tylenol for the pain and irritation. It helped. This lasted about a week and has gone away.  2nd Dose - two days after my shot my right arm that was injected started to feel the exact same way as my left arm did the first time. It itched real bad and turned red and swollen. . It is a very uncomfortable feeling. I am doing the same thing that i did during the irritation of my first arm. It seems to be getting better each day.
Developed wheezing 24 hours after the vaccination.  Wheezing subsided after 4-5 days with oral medication.  Proventol and Prelow (Prednisolone).
Right sided facial tightness pt states similar reaction to alcohol consumption. Moderna Covid 19 Vaccine Lot: 011L20A EXP: 07.03.2021 NDC# 80777-273-99
4p pt developed a firm red raised rash on pts lower back, forearm - underside and deltoid area. Mother unsure of which side. Rash faded. 6p rash returned, pt given 12.5mg BENADRYL chewable. 8a rash returned. on 8a on lower back.  BENADRYL 12.5mg given.
On 03/15/2002 right upper thigh red, warm area size of a saucer. (cellulitis)
Itching+ red blotches on arms + legs on Thurs.  afternoon.  Patient was at the beach earlier in the day.  Small, red bumps on the arms + legs.  Patient took CHLORTRIMETON and it has resolved.
The nurse in the clinic gave my daughter two QUADRACEL injections, one in the deltoid and the other in the SQ space in the L arm. She brought in wrong vaccines and accidentally threw one away and instead of investigating the one she threw in the sharps went back and got another QUADRACEL and gave it. I was notified 24 hours later of the. She then had a local reaction at both sites that were greater then quarter sized.
Fluid around heart - causing PVC's / ventricular tachycardia.  Shortness of Breath / palpitations.  October - November 2021. Treatment - new medicines.
Low grade fever started 1/18 around 1400: 100.4 F, accompanied by body aches, chills, fatigue and headache. Fever spiked 1/19 around 1445: 103.2
Developed COVID-19 after 4 doses of vaccine. First 3 were Moderna
Fainted about 2 - 3min after receiving vaccine with seizure like activity (probably secondary to fainting) pale, nauseous, shaky, low BP. Seemed to recover after 15 min, then fainted again(decrease in BP 84/56) elevated feet another 10-12 minutes, recovered. Took liquids. Walked out OK with mother
had covid twice and been getting sick a lot./She woke up with fever; had covid twice and been getting sick a lot.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 7-year-old female patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), single (Batch/Lot number: unknown) and as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "had covid twice and been getting sick a lot./She woke up with fever"; COVID-19 (medically significant), outcome "unknown", described as "had covid twice and been getting sick a lot.". The patient underwent the following laboratory tests and procedures: Allergy test: negative, notes: negative for mold, cats & dogs, wheat and weeds and all that." The results showed she has no allergies; Antibody test: no antibodies to streptococcal pneumoniae,, notes: no antibodies to streptococcal pneumoniae, 23 serotypes; antibodies, notes: IGG, IGA are present, but some are not present , some are extremely low and some are normal; Computerised tomogram: enlarged lymph nodes in her abdominal region, notes: enlarged lymph nodes in her abdominal region; Full blood count: Not immune to Chicken pox, notes: Not immune to Chicken pox, (varicella antibodies) no antibodies to streptococcal pneumoniae, 23 serotypes; Red blood cell count: elevated, notes: elevated; SARS-CoV-2 test: Positive; White blood cell count: low, notes: low; normal, notes: was normal but on the higher range of normal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective, covid-19 and syncope with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300004133 Same patient/vaccine, different dose;US-PFIZER INC-202300003782 same patient, different dose vaccine and event;
ON 12/16/2013, PATIENT CAME IN FOR ANNUAL SEEN BY NURSE PRACTITIONER AND RECEIVED PNEUMOCOCCAL VACCINE. ON 12/18, PATIENT PHONED THE OFFICE, 10AM, STATING SHE GOT A REACTION TOWARDS THE PNEUMOVAX VACCINE. SHE WAS DOING WELL IN THE MORNING BEFORE AND AFTER THE SHOT BUT SLOWLY THROUGH THE THE DAY SHE FELT BAD W/CHILLS, ARM PAIN (BUT SHE HAS HAD A HEAD COLD). SHE NEEDED HELP TO GET DRESSED THE EVENING OF THE SHOT AND THE DAY AFTER THE SHOT. SHE STATED THERE WAS A RED STREAK THAT WAS HURTING ACROSS HER DELTOID TO THE AXILLA. WHENEVER THERE WAS MOVEMENT THE PATIENT COMPLAINED OF PAIN ON A SCALE OF 1 TO 10 THAT THE PAIN WAS A 5 AND WITH NO MOVEMENT IT WAS A 2. LAST TIME THE PATIENT HAD A STREAK EVERYONE WAS EXCITED AND THOUGHT SHE SHOULD BE SEEN. SHE'S BEEN TAKING IBUPROFEN. PER NURSE PRACTITIONER PATIENT WAS PHONED AND WAS SEEN TO EXAMINE DELTOID. PATIENT WAS GIVEN ANTIBIOTIC TREATMENT.
Left arm became itchy and began swelling at injection site around 2:00 pm on 3/22/18. Within 3 hours, the entire upper arm was swollen, hard, very sore, and hot to the touch. The flesh around the injection site was raised. The swelling extended past the elbow by Friday morning (3/23/2018). The arm was yellow in color by Saturday (3/24/2018). We called the doctor's office around 4 pm on 3/22/18 and again around 10 am on 3/23/18. Both times they recommended taking my mother to the ER. We opted NOT to do that given her advanced age and recent bout with bronchitis. We did not wish to expose her to anything in the ER. Her breathing was not impacted by the swelling in her arm. But her range of motion in her left arm was very restricted due to the intense swelling and soreness. Swelling in the arm persisted until 3/27/2018. The arm is still yellow as of this posting. There is no bruising.
Redness, soreness, swelling of Rt arm that started on 4/1/08.  Received Pneumovax 3/31/08.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 81-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 13Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: EW0150) at the age of 81 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Type II Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient has no history of COVID-19 infection. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovered" (Jan2022) and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (PCR test): (04Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 25Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 25Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 05Aug2022; DILTIAZEM HYDROCHLORIDE, start date: 03Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Negative, notes: After having tested negative on 12Aug2022; (14Aug2022) Positive, notes: I tested positive today 14Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: vaccine received reported as yes. Other medication in 2weeks reported as yes. COVID 19 Treatment includes Paxlovid with treatment start date 05Aug2022 and stop date 09Aug2022. Other medication in 2weeks product reported as Atorvastatin 40 mg with stop date 05Aug2022 and Diltiazem Er (cd) caps, 120 mg with start date 03Aug2022. Patient reported there were none other than pain add the injection site. If you are talking about adverse events regarding Paxlovid. Patient tested positive 14Aug2022, After having tested negative on 12Aug2022. Patient was asymptomatic. Known allergies reported as no.
Cold; Congestion; Sinus infection; Vaccine exposure during pregnancy; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), SINUSITIS (Sinus infection) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 05-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion) and SINUSITIS (Sinus infection). On 09-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion) and SINUSITIS (Sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Migraine medicine and Mental health medicine. Patient had scheduled for second Moderna vaccine on 4-6-2021.