chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; 2 doses of Moderna bivalent vaccine was administered BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered BUD) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered BUD).    Concomitant product use was not provided by the reporter.  It was reported that 2 doses of Moderna bivalent vaccine was administered BUD.  Treatment information was not provided.  This case contains information about patient 1st out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726786:patient 2
Information has been received from a female who in March 2007, was vaccinated with Gardasil.  She had no adverse experience at that time.  On 07-MAY-2007 the patient had her second dose of Gardasil.  On approximately 09-MAY-2007 the patient experienced a "hard swelling" at the injection site.  The patient reported that she sought unspecified medical attention.  The patient's hard swelling at the injection site persisted.  No further details were provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/174/2007. Information has been received from a registered nurse and a 24 year olf female (weight 130P, height 60") who on 02-MAR-2007 at 08:45 am was vaccinated with the second dose of GARDASIL vaccine (Lot #656049/0187U), IM. She had no adverse experience at that time. On 07-MAY-2007 at 9 am, the patient had her third dose of GARDASIL vaccine (Lot #657736/0389U), IM. concomitant medications was not reported. On approximately 09-MAY-2007, the patient experienced a "hard swelling" at the injection site. The patient reported that she sought unspecified medical attention and treatment with warm soaks was recommended. On an unspecified date, the patient recovered from the hard swelling at the injection site. No further details were provided. Additional information is not expected.
3/15/21 Starting in the evening about 6:00 after vaccine sore arm; redness; swollen; head fog; weakness; fatigue Middle of the night: cold chills; increased need to drink water; night sweats; could not regulate body temperature;. aches all over body; headaches. 3/16/21 Morning rash on arm; nausea; vomiting; fever 99.2; head fog around 5:00 am.  8:00 am went to the doctor. Fever 99.3 . ran tests. allergic reaction to shot.
COVID 19 vaccine - unsure which vaccination  Flu like symptoms for 1 day with noted thrombocytopenia 127 x 10^3  Unclear if thrombocytopenia is  from vaccination. No hx of this
Noted bruised and red, swollen, tender area mid right deltoid warm and painful to touch.
got Covid-19 after being vaccinated; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (got Covid-19 after being vaccinated) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Covid-19 after being vaccinated). At the time of the report, COVID-19 (got Covid-19 after being vaccinated) outcome was unknown.        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 relevant concomitant medications were reported.  No treatment information was provided.
This case was reported by a healthcare professional and described the occurrence of an allergic reaction in an adult male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date in 2005, the subject received a dose of influenza virus vaccine (manufacturer and dose number unspecified). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time after vaccination with flu vaccine, the subject experienced "an allergic reaction which was possible due to thimerosal." At the time of reporting on 10 November 2005, the outcome of the event was unspecified. Follow-up information received on 15 November 2005 indicated that the reporter had no additional details regarding this event. No further follow-up will be conducted.
Patient presented to the ED with GI bleed and was subsequently hospitalized within 6 weeks of receiving COVID-19 vaccination.
This case involves a patient (unknown age and gender) who was so sick for 3 days (illness), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient was so sick for 3 days (illness, non-serious), it was awful [unknown latency] following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. There were no laboratory data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported events. There will be no information available on the batch number for this case.
Patient complains of puffiness/ slight tingling on fingers. Provider noticed some 'whitish patches' on finger tips of right hand.
This spontaneous report has been received from a medical assistant referring to a 4 years old patient. Gender, medical history, drug and allergy history and concurrent conditions were not reported. On 04-MAY-2017, the patient was vaccinated with an expired dose of PROQUAD which had a lot # L044056 and an expiration date 02-MAY-2017, (dose, route and anatomical location were not reported) for prophylaxis. The patient's concomitant therapy was not provided. No adverse events were reported. Additional information has been requested.
Dry cough, mild wheezing, and mild shortness of breath began ~11:30 pm 1/12/21. Slight relief for 90 minutes from albuterol at 9:00 am 1/13/21. No change with expectorant guaifenesin at 2:00pm 1/13/21.
After approximately 6 hours I startedto feel a sore throat; After 12 hours couldn't fall asleep; Pain in my arm; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 13:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date. The patient did not receive any concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 19:15, approximately 6 hours after vaccination, the patient started to feel a sore throat and after 12 hours, she could not fall asleep because of the pain in the arm and the sore throat on an unknown date in Apr2021. The events did not result in a visit to doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events sore throat, could not fall asleep and pain in the arm were not recovered at the time of this report.  No follow-up attempts are needed ; information about lot/batch number cannot be obtained.
Some swelling in her thumb; her thumb  was reddish in color and index is more reddish in color; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Some swelling in her thumb) and ERYTHEMA (her thumb  was reddish in color and index is more reddish in color) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (Some swelling in her thumb) and ERYTHEMA (her thumb  was reddish in color and index is more reddish in color). At the time of the report, PERIPHERAL SWELLING (Some swelling in her thumb) and ERYTHEMA (her thumb  was reddish in color and index is more reddish in color) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Reporter'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.
HOSPITALIZATION WITH COVID-19 PNEUMONIA 2/4/22 TO PRESENT
After a week of the first dose i noticed that i was having red bumps on the palm of my hands, then the next day i saw that the vaccine site was red also and it's like a red lump and it itches...Also my hand hives itches alot and i also have them in the bottom of my feet...It feels uncomfortable.
Delayed reaction 4 weeks after injection (28 days) rash, intense itching over entire body went to 2 specialists Rx-ATARAX 50mg 3 x day.
Both legs below injection site turned red, both anteriorly & posteriorly for a few minutes. Recovered within about 10 minutes.
LEFT ARM SORE AT INJECTION SITE. PATIENT COMPLAINING OF SORENESS UNABLE TO LIFT BECAUSE HIS ARM WAS SORE.
she had the PNEUMOVAX 23 vaccine and she had a reaction; after she was given the vaccine her arm became swollen from the shoulder to her wrist; This spontaneous report was received from a currently 92-year-old female patient who was referring to herself. Her medical history and concomitant medications were reported as none. There was no information regarding her concurrent conditions.  On an unknown date in 2009, the patient was vaccinated with a shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) in the left arm (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis, as she was at the 5 year mark (details not provided) and the physician suggested her to get the pneumonia shot. On an unknown date in 2009, after she was given the vaccine, her arm became swollen from the shoulder to her wrist and she had to go to hospital to get a steroid injection (unspecified). As swelling did not go down, the patient had to go to her primary physician to get a second steroid shot (unspecified). On an unknown date in 2009, after few days, the swelling went away.  The reporter called because she read that before getting a Coronavirus disease of 2019 (COVID-19) vaccination, the patient should make sure he or she is not allergic to polyethylene glycol.  The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was unknown.
Onset of neurologic weakness, fatigue - severe myalgias, focal pain, faint rash, severe HA.
breakthrough COVID infection in September some increased oxygen needs but otherwise unremarkable hospitalized for pulmonary embolism
Patient Stated that after she received the flu shot she felt rashes under the skin. Then she felt better after taking Benadryl.
Pt felt very anxious, wanted to walk around.  EMS took vitals 183/82 HR 112 SaO2 98%.  Pt gradually calmed himself, was able to move out of the drivers seat to passenger side, allowed to leave after 30 min
Intense itching and pain on chest, neck and inside of right ear. The pain and itching on the right side of my chest started 2 hours after injection and I felt hot. Took an antihistamine and it resolved only to come back about 8 hours later on the other side of my chest moving up on my neck to my chin and inside of the opposite side ear. Another antihistamine did not help. The doctor prescribed Benadryl, Allegra and hydrocortisone cream. He said it might be an allergic reaction to the new shot or a beginning of shingles. It has gotten better the last two days, one of which I had not taken any meds.
Swelling at injection site after 3 days(could not lay on left side)-Fever of 102-Chills-No appetite(did not eat for 2 days)-Dehydration-Fatigue-Extreme Pain thru out body-could barely walk to toilet
chills, fatigue, severe body achs, dizziness, rash on forearms accompanied by itching, nausea, all over body weakness.
Patient complained of increasing swelling/warmness/pain/redness in the area surrounding the injection site.
Fever of 101-102, chills, muscle aches, fatigue, headache, nausea and diarrhea that lasted ~36 hours
19:30 10-1-09 Ears ringing. 20:30 10-1-09 Bloody nose, bloody stool.
The following day I had a round, itchy, painful, red lump. It is hot to the touch. Very painful if arm rubs against something. But today, 3 days later, it seems to be spreading. At least 5 inches uneven n 5 inches across but going to back of arm. It feels like a big lump that's very hot to touch. There are also white marks in red area like hives?
Erythematous patch approx 4 inches in diameter around administration site on left arm w/ itching; started itching about 23 hrs after administration.
Depression, memory impairment, slow gait, isolating himself, decrease in grades, speech-lower voice, less interactions, and psych motor retardation. He has had Neurology evaluation, hospitality and psychological evaluation.
pt recv vax 23NOV96 & a few days later, pt exp a rash w/6 lesions on the vaccinated arm;
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. An adolescent female patient received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, few weeks after vaccination, the patient was treated by hospital neurologist for Bell's palsy. The outcome of the event was unknown. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Treatment of COVID-19; Treatment of COVID-19; Dose number=5/ Dose number=4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 13:00 as dose 1, single (Lot number: EL9261), in right arm, on 12Mar2021 at 13:00 as dose 2, single (Lot number: EN9809), in right arm and on 19Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16May2022 at 13:00 as dose 4 (booster), single (Lot number: 038A22A), in left arm and on 01Nov2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16May2022 at 13:00, outcome "unknown", described as "Dose number=5/ Dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Mar2023) positive, notes: tested positive for Covid on 03Mar2023; (10Mar2023) negative, notes: tested negative for Covid on 10Mar2023; (12Mar2023) positive, notes: tested positive today, 12Mar2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with other medications in 2 weeks of Paxlovid. Patent was tested positive for Covid on 03Mar2023, and immediately started taking Paxlovid, then tested negative for Covid on 10Mar2023. On 11Mar2023, patient stated sneezing and blowing her nose, which continued today, 12Mar2023. So far, the patient not had any sore throat, coughing or fevers, like she did when she first got Covid. Patient coughed for 3 days with the initial infection, and although she still had phlegm on her chest and not coughing much now. She was again tested positive 12Mar2023. No known allergies.
He got his vaccine, nothing really happened until the next morning.  He was at work and he started to experience some muscle weakness and some involuntary muscle movement where he was just kind of hunched over a little bit.  His voice was affected, started slurring and not quite back to where it was before.  He has to focus to talk like he used to do.  He was woozy and went to get something to eat, was nauseous, weak and disoriented . Once he ate and drank he started to feel better.  He went to the ER and has been there 3 times for the same issue.  They told him that they did not know what was wrong, he had had medication adjustment and change.  He was still presenting with the involuntary muscle movement, BP and blood draws gave him uncontrolled involumtary muscle movement.  His legs and feet are feeling like he is dragging around cement blocks, his toes tingle and cannot bend them without making him hunch over.  He was training for a 5K race, and now he cannot put on his socks without sitting on the floor now.  Every time he tries to do coping skills, working out and deep breathing, the symptoms were return like he was having a seizure.  He saw a neurologist yesterday and is going to run tests and referred to another specialist, to a movement disorder specialist through Clinic. He went to the ER at clinic 3 times and got a 2nd opinion at ER at Hospital.  They ran more tests and was told to go back to his providers at the clinic and stay on them until he got an appointment with neurology and psychiatry.    He has his own theory and is following up with his therapist and feels that maybe his lithium and Seroquel are playing a roll in his symptoms.
Received an injection in the left arm which the vaccinator reports to have been empty of the vaccine based upon the lack of resistance felt upon injecting.  A second injection was administered which was described to have felt the same as the first,  The vaccinator believes that the second syringe was filled with air and not vaccine solution and there fore believes that the patient didn't receive a dose of vaccine.  This incident occurred at a mass vaccination setting.  Patient has not reported any signs or symptoms post vaccination.  Denies experiencing symptoms typical of vaccination following Covid vaccination.
about 10 hours after the vaccine, my hands became swollen, red, pressure, tingling with sharp pains.  There were white blotches on my hands and my blood pressure was up.  My body was stiff and achy for 2 days.  8 days later the same hand sensation and white blotches appeared again for a few hours.  I have had more colitis and arthritis symptoms since the vaccine.  I was at our vacation house. I previously tried to report but it did not work.   I did not seek health care attention due to the fact that I was not sure if my medical insurance would cover this issue.  I have photos of my hands during both incidents.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved by State o for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
After receiving shot, patient reported feeling warm after sitting down in post observation area. Felt  anxious and lightheaded.  Vital signs taken x2 - stable.  Offered and drank water and laid down.  Feeling of warmth and lightheadedness resolved after about 10 minutes.  Patient reported feeling better, conversing and laughed with clinic staff.  Exited clinic after 40 minutes and observed gait was steady.
red; itchy; sensitive; rash at the injection site; a little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen). At the time of the report, RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
today (7/14/21) patient came in for a second Covid 19 vaccine dose (1st dose -given 6/23/21- was Pfizer's Covid 19 vaccine). The dose given today was Moderna Covid 19 (in error)