chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 27-AUG-2014, the patient was vaccinated with PNEUMOVAX23, injection, (lot # J004080, Exp. Date: 22-AUG-2014) (strength and dose not provided). Co-suspect or concomitant therapies were not reported. On 27-AUG-2014, at the time of the vaccination the dose of PNEUMOVAX23 was expired. No adverse effects reported. Additional information has been requested.
Patient developed swelling on hands 5 minutes after receiving second dose of Moderna vaccine on left deltoid. Patient was administered Benadryl 50 mg IM in right deltoid. Monitored patient for an additional 30 minutes which swelling gradually decreased.
Patient received Moderna booster dose. She received the 21st dose out of the vial. It was later found out that the vial is only supposed to be punctured a max of 20 times. Patient has reported no adverse events.
This case was reported by a nurse via call center representative and described the occurrence of injection site wheal in a 20-year-old female patient who received BEXSERO. On 15th June 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site wheal and injection site blisters. BEXSERO was continued with no change. On an unknown date, the outcome of the injection wheal and injection site blisters were recovered/resolved. The reporter considered the injection site wheal and injection site blisters to be probably related to BEXSERO. Additional details provided as follows: The age at vaccination was not reported. The patient experienced a 1 inch welt with blisters at the injection site after receiving BEXSERO. The welt lasted for about 1 month. The patient received the 2nd dose of BEXSERO and did not have pain at the injection site. No other vaccines were administered.
Hives for weeks requiring Benadryl, worsening of food allergies as patient was hiving from eating many things she had previously been able to tolerate, irritability such as inability to sit in car seat for any length of time without screaming and crying which is completely uncharacteristic, disrupted sleep with waking and screaming for no apparent reason, crying and irritable every day for unknown reason which is totally uncharacteristic of child.
I received a flu shot. I do not know which one you list is the one that was administered. I would have to ask my doctor. Within a few days I developed hives on the trunk of my body. While they have lessened, I now have them on my face and arms as well. They tend to subside after 8-10 hours sometimes with the assistance of my topical psoriasis medication.
Information has been received from an office manager concerning a male who was vaccinated subcutaneously in the deltoid with a 0.65 ml dose of Zostavax (Oka/Merck).  Subsequently, within 4 days post vaccination, the patient developed a" mild case of shingles".  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
approximately 5 minutes after receiving vaccination patients boyfriend said that she was filling light headed.  I went to the waiting area to check on patient and take her blood pressure.  while taking patients blood pressure she had a short (1-2 seconds long) seizure and lost consciousness.  Patient quickly regained consciousness and reported no additional symptoms.  EMS arrived on the scene quickly and patient left with them.
cough, SOB, myalgias, nausea. body aches, fever, hypoxemic resp faliure secondary to COVID. treated with dexamethasone, zinc and O2. home on RA. no remdisivir given
temperature excursion for PEDIARIX, administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 4-Aug-2022 Reporter comment: The reporter stated that the temperature excursion for Pediarix that was administered to the patient.  The temperature excursion with a lowest temperature of 35.9 Fahrenheit was for 40 minutes on 18th July 2022. Additional Supportive Information: Pediarix was at lowest temperature of 35.9 Fahrenheit  for 40 minutes, which lead to Incorrect storage of drug. This case was linked with case US2022AMR115318, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR115318:Same reporter
Red itchy swollen lump at injection site 9 days after injection; red itchy swollen lump at injection site 9 days after injection; red itchy swollen lump at injection site 9 days after injection; This is a spontaneous report from a contactable Other healthcare professional. A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264) via an unspecified route of administration in left arm on 30Jan2021 at 14:15 as DOSE 1, SINGLE for covid-19 immunization. The patient was hypothyroid. The patient had no known allergies. The patient's concomitant medication included metformin (MANFCTURER UNKNOWN); thyroid (ARMOUR THYROID) received within 2 weeks of vaccination. Patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID post vaccination. On 08Feb2021 at 21:00, the patient experienced red itchy swollen lump at injection site 9 days after injection. The patient did not receive any treatment for the event. The outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a patient who on approximately 4/12/2006 was vaccinated with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Subsequently, approximately 4/12/2006, the patient developed an eraser like bump at the injection site. At the time of the report the patient had not yet recovered. Unspecified medical attention was sought. No lab diagnostic tests were preformed. There was no product quality complaint involved. Additional information has been requested.
This event was an administration error. The patient is 14 years of age and below the EUA approved age of 16 years. This individual was vaccinating in the presence of 3 other family members who also were vaccinated on March 3rd and March 24th. The family members who were also vaccinated were the child?s parents and 16 year old brother. The vaccine clinic staff who registered (intake) did not catch that the child was 14 years of age. The father is the one who registered the entire family including his two children (16 and 14 year olds) via our online scheduling system which does have a disclaimer stating the vaccine is only approved for use in those 16 years and older as we are a Pfizer site.  The parents did not disclose the age of the child when registering in our POD.  This administration error has been reported to  Dr., DOH Medical Director.  Our Vaccination POD has implemented processes to confirm age prior to administering the COVID Pfizer Vaccine.
arm hurt a little bit; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired). On 28-Mar-2021, PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-356505, MOD-2021-356638 (Patient Link).
12 cm area of right upper thigh with redness, heat, swelling, hard. Developed overnight and next day. Child brought to clinic 6/6/03. Not seen by MD. Condition resolving. Area now pink, soft, no heat, decreased discomfort.
Summer of 2022, I got sick that started with a cold.  I tested negative for COVID-19.  I had a cough.  The doctor prescribed albuterol and a cough suppressant. The cough was so bad I was unable to control it.  I began to feel better for several days but then tested positive for COVID-19.  My symptoms were cough, nausea, vomiting, itchy skin, diarrhea and the head cold symptoms.  I still have the cough today.  I have had several chest X-Rays.  I got my 4th dose in October 2022.  I had an EKG in January and wore a heart monitor for two weeks.  I am scheduled for an echo cardiogram and a pulmonary lung function test.
blood clot; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization; Bnt162b2 (Dose 3), for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clot". Patient already took Pfizer Covid-19 Vaccine and 2 doses of Booster shot and then he's having health problems and he wanted to know why the shot gave him blood clot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Sept 25 I asked for pneumonia shot. Medicare charge sheet said I got flu shot. Pharmacist records said flu shot. Got (second?) pneumonia shot on 2/17/10. By 11 pm, had soreness and tightness in right neck and back of right shoulder, the same side as the shot. Advanced to acute pain in neck that seemed like spasm in neck by morning of the 18th. Treated with aspirin, then prednisone. Abates some but still bad on morning of 19th. Visited doctor on late afternoon 19th, added muscle relaxant to prednisone.  Improving by morning of 20th with tolerable tightness and movement.
Wheezing, edema around injection sites and fine bumpy rash around injection site. Pt. was prescribed PRELONE 5mg/5ml for inflammation.
Started with a very sore arm with redness and warmth to the arm around 11PM and by 2AM started with chills but no elevated temp and then nausea.  She reports she slept 12 hours and was then doing well.
3 days p/vax pt devel a rash on chest & back;this is 1 of 3 pt from this facility to devel a rash p/vax;
Jynneos was administered intramuscularly; Case reference number US-BN-2022-001860 is a spontaneous case report initially received from a healthcare professional on 09-Aug-2022 and concerns a patient of unknown demographics (first out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  This case is linked to cases no. US-BN-2022-001861, US-BN-2022-001862, US-BN-2022-001863, US-BN-2022-001864, and US-BN-2022-001865 concerning the same reporter.  Additional information was received on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients, information about needle, local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a healthcare professional on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. Inappropriate route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. Inappropriate route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
This spontaneous report was received from a 70 years old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies who on 04-FEB-2013, was vaccinated with a dose of ZOSTAVAX (dose and lot number not reported). There was no concomitant medication. The consumer reported that she had developed two episodes of reaction on her legs. The first episode began on 28-FEB-2013, and the second episode began around 13-MAR-2013, In both episodes, welts that were dark in color formed on the legs and felt hot and very itchy. The consumer stated that the welts lasted about 6 or 7 days each time and then subsided. In first episode, the welts were about the size of a quarter, and in the second episode the welts were about the size of a silver dollar. It was reported that the second episode was worse that than first. No treatment was given for the experience. The patient did not seek medical attention but planner to see a dermatologist. The relatedness for welts that were dark in color formed on the legs and felt hot and very itchy and ZOSTAVAX was unknown. Additional information is not expected.
12/3  Mother consulted physician due to fever and sinus infection. Prescribed Augmentin. 12/8 15 month well baby visit. Nurse was advised that child was on antibiotics for infection and questioned whether or not he should receive vax. Doctor advised that there should be no problem. 12/18 child returned to pediatrician with continued sinus infection-green discharge from nose, cough, congestion, temperature normal. Antibiotic was prescribed. Approximately 5.5 hours later, child cried once from crib. Mother picked him up and noted he was having a seizure. Called 911. Child was having trouble breathing at this point. In ambulance, temp was 104.7. Child stopped breathing and paramedics began intubation procedures. At this point he began breathing on his own and they ceased the procedure. Seizing subsided approximately 20-25 minutes after onset. At hospital, a Tylenol enema was administered for the fever. Pt was lethargic. When pt began to move about it was noted that he was not moving his right arm or leg (right hemiparesis). A CAT scan was performed. He was then transferred to a medical center having a pediatric neurologist. Parents were informed that child had suffered from Todd's paralysis which commonly follows febrile seizures and paralysis should resolve in a few hours. Four to 5 hours later, full movement returned. Spinal tap was performed to rule out spinal meningitis. Parents were informed that child had experienced a complex febrile seizure. EEG was performed to rule out brain damage or abnormalities due to difficulty breathing and lack of oxygen (he had turned blue during seizure). 60 day follow-up dated 7/10/00 provided no additional data.
Injection site was red; injection site was painful; hand fingers were swollen on left hand for 3 to 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand fingers were swollen on left hand for 3 to 4 hours), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (injection site was painful) in a 61-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 PERIPHERAL SWELLING (hand fingers were swollen on left hand for 3 to 4 hours), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (injection site was painful). At the time of the report, PERIPHERAL SWELLING (hand fingers were swollen on left hand for 3 to 4 hours) had resolved and VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (injection site was painful) outcome was unknown.            Concomitant medications were not provided by the reporter.   Treatment information not provided.
Second dose of Pfizer Covid19 vaccine administered early, child received the first dose on 2/3/22
The vaccine was administered in the right deltoid muscle. Below the injection site appears to be red, swollen, and painful. The patient was instructed to take over-the-counter pain relief (acetaminophen), BENADRYL, and a cold pad against the skin. The patient refused to take any medications to help.
he was given his 3rd dose in the primary series at 4 weeks instead of the intended 8 weeks.; he is not sleeping the same since that shot (Pfizer COVID-19 Vaccine); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 11-month-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "open heart surgery" (unspecified if ongoing), notes: He has a history of Open Heart surgery. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "he was given his 3rd dose in the primary series at 4 weeks instead of the intended 8 weeks."; INSOMNIA (non-serious), outcome "unknown", described as "he is not sleeping the same since that shot (Pfizer COVID-19 Vaccine)". Therapeutic measures were not taken as a result of insomnia. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: The reporter reported that her son got three doses of the vaccine and he was 11 months old. She stated that her son got the 3rd doses too early as primary series at 4 weeks instead of the intended 8 weeks by the pediatrician and wanted her son to be approved for the 3rd dose. The reporter reported that the patient has a history of open heart surgery and he has not been sleeping the same since the last shot. Prior to vaccination the patient received Flu Vaccine, 3 weeks before he got the third dose of Pfizer COVID-19 Vaccine.
Psoriatic arthritis flare; Psoriatic arthritis flare/symptoms were came back; pain; Humira did not work well; drug interaction; car accident; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4378855-00 (Agency).  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 08Apr2020 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg, [citrate free (40 mg, 1 in 2 week)]), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ROAD TRAFFIC ACCIDENT (non-serious) with onset 2017, outcome "unknown", described as "car accident"; PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "Psoriatic arthritis flare"; PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "Psoriatic arthritis flare/symptoms were came back"; PAIN (non-serious), outcome "unknown"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "unknown", described as "Humira did not work well"; DRUG INTERACTION (non-serious), outcome "unknown". Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of car accident, psoriatic arthritis flare, psoriatic arthritis flare/symptoms were came back, pain and humira did not work well was not provided.  The reporter's assessment of the causal relationship of "psoriatic arthritis flare", "psoriatic arthritis flare/symptoms were came back", "car accident", "pain" and "humira did not work well" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events psoriatic arthropathy, pain and therapeutic product effect incomplete and drug interaction and the suspect drug BNT162B2 cannot be excluded. Based on known disease pathophysiology, the event of road traffic accident is assessed as not related to BNT162B2 and more likely due to accidental cause. 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.