chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her second dose of the COVID vaccine (Moderna) on 6/8/21 in her left arm. On 6/9/21 she had minor pain in her hip area on her left side, but pain had subsided. On 6/10/21 she came to pharmacy and reported more severe pain in her hip area this time on her right side and the pain would occasionally shoot down her leg. She then went home to rest. I called patient to check on her around 6PM on 6/10/21 and she reported she was feeling better while resting, but still has pain, especially when up.
Patient was given an adult dose of Pfizer Covid vaccine in error. It was  noted immediately after by administering pharmacist. Parent was notified by phone and advised as to possible adverse reactions and asked to follow up with pharmacy manager as need. First dose was given correctly 1/21/22 as Pfizer
Administered hiberix without the diluent; Administered hiberix without the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) (batch number 335N9, expiry date unknown) for prophylaxis.   On 26th April 2022, the patient received Hiberix. On 26th April 2022, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Registered nurse reported that, there were 3 vaccines that were administered hiberix without the diluent. She was unaware of how these vaccines were reconstituted so were unable to give any information. The reporter consented to follow up. Additional Supportive Information:  The patient received Hiberix without the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022075751:Same reporter.
her left leg was swollen; two red clots on left leg; right feet was hurting; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two red clots on left leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 03-Mar-2021, 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 (her left leg was swollen), THROMBOSIS (two red clots on left leg) (seriousness criterion medically significant) and PAIN IN EXTREMITY (right feet was hurting). At the time of the report, PERIPHERAL SWELLING (her left leg was swollen), THROMBOSIS (two red clots on left leg) and PAIN IN EXTREMITY (right feet was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Diagnosed with Lymes disease in 1998. Asymptomatic until 2/21/00. Third Lymes vaccine received 2/17/00. On 2/21/00 presented with sx of pain upper right arm muscle, lethargic, head pressure and cognitive impairment. On 5/00 presented with bronchial cough. 6/9/00 presented with dizziness. On 7/3/00 was still dizzy. Diagnosed by ENT specialist with benign paroxysmal postural vertigo. On 10/7/00 presented with cold sx and sinus and ear infections and pain in right upper arm. Still suffering from diminished concentration and cognitive functions and lethargic and head pressure. From 10/19/00 to 3/21/01 still had the same sx and was referred to allergist. On 04/19/01 presented with pain in upper arm radiating to neck, shoulder and clavicle, occasional heart flutter, head pressure and cognitive impairment. On 7/16/01 had diarrhea. On 8/06/01 to 8/09/01 while reading letters ran togather and her entire body felt like it was vibrating. Became bedridden. Symptoms gradually subsided with stiff neck and head pressure and lethargy.
patient had previous history of reaction to MMR vaccine as a child including face swelling and hives. Recommended patient to remain in pharmacy for 30 minutes following covid vaccine. Approx 6 minutes after receiving vaccine patient came to pharmacy with symptoms of throat swelling, redness in face and tingling lips. Administered one dose of epinephrine and called 911. Patient was responsive to treatment and was evaluated by emergency medical personnel.
Patient developed cellulitis 2 days after receiving the vaccine. She was treated at urgent care by MD. She received KEFLEX 500 mg QID, prednisone 20 mg BID, ibuprofen 600 mg TID.
severe chills, body aches and fever for 36 hours.  The side effects were worse than COVID in December 2020
Mixed Series given.  1st dose Pfizer on 3/28/21, second dose Moderna on 4/19/21
FEVER 103, LOCAL REACTION OF PAIN SWELLING AND INCREASED WARMTH SCREAMING EPISODE LASTING APPROX. 6 HRS FOLLOWING DTP/OPV IMMUNIZATION.
Red, lacy patterned face rash on cheeks and ears, rash around injection sight, muscle weakness in left leg preventing normal use/bearing weight.
Dizziness after Bivalent Booster; Low Fever after Bivalent Booster; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness after Bivalent Booster) and PYREXIA (Low Fever after Bivalent Booster) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 029B22A) for COVID-19 vaccination.     Previously administered products included for Cancer: Rituxan from 2020 to 27-Apr-2022. Past adverse reactions to the above products included No adverse event with Rituxan. Concurrent medical conditions included Cancer since 2019 and Immunocompromised.    On 26-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced DIZZINESS (Dizziness after Bivalent Booster) and PYREXIA (Low Fever after Bivalent Booster). On 29-Oct-2022, DIZZINESS (Dizziness after Bivalent Booster) and PYREXIA (Low Fever after Bivalent Booster) had resolved.            No concomitant medications were provided.  The patient received First Primary monovalent dose on 09-Feb-2021 with lot number 007M20A, second primary monovalent dose on 09-Mar-2021 with lot number 002A21A, third dose monovalent (not sure if half dose) on 14-Aug-2021 with lot number 088D21A. Antibody tests on May-2021 and Jan-2022 showed no detectable antibody.  As the patient was on Rituxan the vaccines were not effective on patient, it did not make antibodies and on an unknown date in Sep-2022 patient received Evusheld antibody pack to prevent COVID disease.  No treatment medication was provided.   This case was linked to MOD-2022-682288 (Patient Link).
Itchy welts all over body, including groin region. Patient stated he took diphenhydramine within 24 hours and it lasted a total of 48 hours.
This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 22-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9 lot # N022584, expiration date 15-JUN-2020, for prophylaxis (strength, dose, route and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1712USA013720.
TYPE-1 DIABETES; COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 23 year old male of unspecified race and ethnic origin. 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced type-1 diabetes, covid, and suspected clinical vaccination failure. On an unspecified date, patient had J&J shot and died from complications of covid and type 1 diabetes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of type-1 diabetes on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000200111.; Sender's Comments: V0:  20211104184-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20211104184-Covid-19 vaccine ad26.cov2.s- Type 1 diabetes, Covid. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COVID; TYPE 1 DIABETES
my eyes, face/were swollen; my eyes, face/were swollen; my eyes, face, nose, and top lip were swollen; top lip were swollen; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Aug2021 19:30 (Lot number: FC3181) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: Salmon, penicillin, neutrogena facial moisturizer, Burt's Bees lip balm, Lacombemakeup; "known allergies: Salmon" (unspecified if ongoing), notes: known allergies: Salmon, penicillin, neutrogena facial moisturizer, Burt's Bees lip balm, Lacombemakeup; "known allergies: neutrogena facial moisturizer" (unspecified if ongoing), notes: known allergies: Salmon, penicillin, neutrogena facial moisturizer, Burt's Bees lip balm, Lacombemakeup; "known allergies: Burt's Bees lip balm" (unspecified if ongoing), notes: known allergies: Salmon, penicillin, neutrogena facial moisturizer, Burt's Bees lip balm, Lacombemakeup; "known allergies: Lacombemakeup" (unspecified if ongoing), notes: known allergies: Salmon, penicillin, neutrogena facial moisturizer, Burt's Bees lip balm, Lacombemakeup. Concomitant medication(s) included: BIOTIN; ZINC. The following information was reported: EYE SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 20Aug2021 06:45, outcome "not recovered" and all described as "my eyes, face/were swollen"; NASAL OEDEMA (non-serious) with onset 20Aug2021 06:45, outcome "not recovered", described as "my eyes, face, nose, and top lip were swollen"; LIP SWELLING (non-serious) with onset 20Aug2021 06:45, outcome "not recovered", described as "top lip were swollen". Therapeutic measures were not taken as a result of eye swelling, swelling face, nasal oedema, lip swelling.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination: No. Patient received the vaccine between 730 and 800 pm that night. The next morning her eyes, face, nose, and top lip were swollen. Her face was still swollen, but just not as bad. Facility type vaccine: Pharmacy or Drug Store.  Follow-up attempts are completed. No further information is expected.
Pt is adopted. Mother states pt real age could be anywhere from 7 - 10. Pt had no adverse events. (Pt given PEDIARIX which should only by given up to age 7 yrs).
Blood clot that started in leg went down to foot; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2), as dose 2, 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, SINGLE), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot that started in leg went down to foot". Therapeutic measures were taken as a result of thrombosis. Clinical course: The patient had blood clot that started in leg went down to foot and had to have a portion of his foot and 2 smallest toes amputated. The patient had no family history of blood clots.  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 information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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
Symptoms got worse throughout the day, extreme pain at injection site, body aches, swollen glands in neck, shortness of breath, dizziness, weakness, fatigue.
Shortness of breath and ?throat tightening.? Dosed with IM Benadryl with symptom relief
Whiteness at injection site with itching. Skin sloughing in the area of whiteness with palpable rash underneath the skin without redness. Persistent itching at the site.
pt recv vax & devel approx 5 chickenpox lesions & itching;
Case number PH#H2013IS023985 is an initial spontaneous report from the consumer received on 12 NOV 2013. This report refers to a female patient of an unknown age. On an unknown date, she received an intramuscular dose of FLUVIRIN 2013/2014 (batch number: not reported) which was drawn from a multi dose vial. At the time of FLUVIRIN vaccination, the patient was pregnant. No adverse event reported following the vaccination.  Follow up information received on 11 AUG 2014: Multiple attempts were made to obtain outcome of event without success. This case is considered lost to follow up.
16 year old was given the vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Child has developed side effects  her right leg around the shot location become inflamed and swelled, it is taking most of her tight making her uncomfortable and in pain. It supposed to be gone after 1-2 days, but is not.
Client received pneumonia vaccine LSQ. Back of right arm began swelling within minutes. Continued to swell all night and is now from elbow to shoulder, almost purple, very tight, and hot. Advised to put cold on area, see MD and contact HD after seeing MD. 40mg Prednisone BIOX 14 days, Benadryl 25mg BIO per Dr. 8/11/04 reaction resolving. No Prednisone taken.
even as a kid they made me sick; Initial information received on 15-Feb-2022 regarding an unsolicited non-serious valid case from Social Media page received from a patient.  This case involves a adult patient of unknown demographics who reported even as a kid they made me sick while receiving Influenza Vaccine.  Past medical history: even as a kid they made me sick (Sickness).  Prior Use: Yes/ Not tolerated.   The patient's concomitant conditions, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (form, strength, route, dose, administration site, batch number, expiry date: unknown) for immunization. Batch number was requested.   On an unknown date the patient reported as a kid they made me sick (illness) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  Corrective treatment: not reported   Outcome was Unknown
7 days after receiving the Yellow Fever Vaccine given SQ in (L) upper arm. He presents with a large oval blistered area at the injection site. Red and purple colored around the blister. No swelling noted. No c/o discomfort from this.
Red rash, itch, hot for 5 days, then a week later March 22, 2021 temp elevated not past 100, rash spread down and around arm itchy, extremely fatigued sleeping 12 hours and still tired.  Three days later 3/25/2021 found a lump on  left collar bone, suspected to be a lymph node.
Complaint of redness, swelling on right deltoid at injection site started 10/16/2014.
Symptomatic submassive saddle pulmonary embolism with IR thrombectomy
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about July 2015, a healthcare provider administered the ZOSTAVAX to the patient. On or about 30-DEC-2016, the patient was treated by the physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
4FEB97 pt recv vax & w/in hr had severe redness, hardness & little red bumps around inj site,warm to touch, high fever & feeling achy all over;10FEB97 rt side of face pulled to lt, unable to close rt eye;taken to ER dx Bell's palsy;
*** I received my vaccine in 12/20 and within 6 hours after first injection I had a bump on the Left inner heel of my foot.  As the days continued I began to develop more bumps on Left heel that traveled to my right foot. In total I have 10 plantar warts that developed which has caused my to be temporarily disabled from work.  Shortly after when I recieved my menstraul cycle, it was extremely heavy and full of large blood clots. This was not my baseline. we are in the month of June and I have had irregular periods ever since vaccine. In March 2020 I had a cardiovascular incident that resulted in a RIGHT BUNLE BRANCH BLOCK. I'm following a cardiologist. I have had multiple issues with my body ever since I received this vaccine and urge the public to please read and educate yourself before you get it. Im just now starting to experience tingling in my arms and legs. All of the issues Ive list are all AUTOIMMUNE ISSUES. This vaccine has destroyed my health and hijacked my immune system. PLEASE BEWARE!!!!!
12 mo vaccines administered on 09-10-12. Pt. seen again in office for cough, cong., runny nose & fever (102), on 09-20-12. (s/s began 9-19-12). Dx with (B) OM & placed on AMOXIL that day. Pt. seen again on 9-28-12 for low-grade temp & rash on trunk, scalp, buttocks & extremities (no itching) which began 9-27-12. Admitted by PCP to hospital on 9-29-12 D/T worsening rash. Dx > serum sickness secondary to Abx (Mom is requesting VAERS report - feels vaccines --> serum sickness).
Within 24 hrs p/immun developed urticaria, diffusely scattered over his body. No respiratory sx occured; tx w/oral antihistamines & recovered fully.
The left side of my neck, ear and head hurt along the same path. It hurts to to tears to turn my neck, lay down and make certain movements. I took Advil and it eased the pain. However, I can still feel it.
mom describes small red knot @ lower inj site morning p/vax then  16SEP98 then 17SEP98 red knot had inc to 5-6cm hard red area;seen by MD dx infect;rx w/duroset;21SEP98 mom described inj area larger & irregular than on 17SEP98;seen by MD;
fever; chills; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (tired) 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 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (tired). On 05-Feb-2021, PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (tired) had resolved. Not Provided          Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.