chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cough; Runny Nose; More than 36 days since first dose without receiving second dose; Hives all over the body; A spontaneous report was received from a nurse concerning a 82 years male patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced urticaria, runny nose, and cough  The patient's medical history was unknown.  Concomitant medication Lisinopril is reported.  11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A ) for prophylaxis of COVID-19 infection.  The patient experienced hives all over the body, runny nose and cough after vaccine administration and that last for 3 days. For the last 3 days no treatment was taken. No lab details are provided.  No Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of urticaria, cough, runny nose was unknown and recovered for missed dose.
Positive pregnancy test in pediatric office.  Date of conception unknown, possibly prior to vaccine adminstration
Bruising on under side of L arm 13cm x 6 cm. Arm very sore.
Full body rash, intense itching, over the course of 5 days. Less itching but still present. Lower lip swelling.
sore arm the day after just like she did with the first two shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: ER8735) at the age of 63 years as dose 1, single and administered in arm left, administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement (ongoing); VALSARTAN taken for blood pressure measurement (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "sore arm the day after just like she did with the first two shots".  Additional information: The concomitant products Amlodipine: been taking a long time, probably since the 80s or something,Valsartan: been taking for years. Report was related to a study or programme. Additional information for other conditions: since the 80s probably, runs in her family. No investigation assessment. Caller states her booster shot was on 29Dec2021 at 2:40 PM (lot no.: 331308A).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My blood pressure is all over the place. I was getting really weak in the middle of the afternoon which I later realized was because it was dipping very low in the middle of the day. I saw my cardiologist on March 15. Stress Test and pulmonary test on March 29 and all the results were showing very mild COPD but no issues with my heart. Blood pressure is going so high that the doctor is considering raising my blood pressure medication but reluctant due to the dips in the middle of the day. They have me currently tracking my blood pressure a few times a day. She is waiting to see whether it is consistently high or low before changing the dosage. I was diagnosed with hyper polycythemia and advised to see a blood specialist.
12.5 cm x 12 cm area of erythema, induration and warmth at injection site. Patient's mother gave BENADRYL and ibuprofen prn and used warm compress to area. Rash occurred within 24 hrs of receiving vaccine.
This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine). At the time of the report, OFF LABEL USE (patient received 2nd dose of Moderna vaccine on 23 days after 1st dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Tingling/spasms in arm, feet, neck, face (starting at 3:30 am -- ongoing. Currently 8:13 pm) Sometimes the tingling feels hot but not always.
Arthritic flare up beginning in mid-July and lasting approximately 6 weeks until diagnosed and treated. The flare up was unusual in that I was otherwise healthy, eating well, exercising  regularly, taking RA meds as prescribed, and had not had a problem of this severity for years.  Flare up consisted of severe pain in upper arms and hands and weakness and tingling /numbness in hands. Originally thought it might be a pinched nerve or TOS, but my rheumatologist suspected an arthritic flare up and prescribed prednisone to verify. The prednisone stopped the pain quickly. My rheumatologist cannot say whether the arthritic flare up was caused by the COVID vaccine, nor could I find any information about whether mRNA vaccines can potentially affect people with autoimmune disorders. This is the reason for filing this report.
Patient was given vaccine reported feeling okay until he stood up. Once he sat down, he said he felt "hot". I gave patient an ice pack and a cold bottle of water to help. Patient then reported feeling tingling throughout his body, shaking, and blurred vision. After closing his eyes for about 6 minutes, he reported feeling better and was okay to leave. He said he'd rest more once he got home.
expiration 9/30/22, administered 10/6/expired vaccine, no more than basic 1st aid needed; This case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-OCT-2022 Reporters comment: The reporter reported that the patient received the Bexsero vaccine on 06th Oct 2022 and expired on 30th Sep 2022 No harm - reached to patient no more than basic 1st aid needed. The reporter did not consent to follow-up. Additional Supportive information: The patient received the Bexsero vaccine which was already expired, which led to expired vaccine used.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am responding to the request for input regarding the use of anthrax vaccine. I do not believe that the anthrax vaccine is safe and effective. I currently work with a soldier who is being medically separated from service. After receiving her first anthrax vaccine, she developed leucocytosis, her hair fell out, was febrile, developed myalgias and polyarthralgias, fatigue, tachycardia, had an elevated sedimentation rate and had to be medically evacuated from theater due to her medical condition. Her condition worsened after receiving a second anthrax vaccine. Currently, she suffers from persistent and debilitating myalgias and polyarthralgias, migraine headaches, fatigue, tachycardia, leukocytosis, memory problems and other significant cognitive deficits and depression. She was in excellent health prior to her anthrax vaccine.
pt recv vax 13JUN97 thrombocyte count on that day was 133,000;12 days later pt thrombocyte count was 62,000 & 20 days p/vax it was 53,000;other tests were planned including WBC antibodies, SMA12, sed count, ANA, & platelet antibodies;
Patient received 3 doses of GARDASIL vaccine, shortly after third dose developed psoriasis HPV#1-3/26/13, HPV#2 6/3/13, HPV#3 10/24/13. Patient 1st seen for rash 2/4/14, mom reports it was there for a while before that.
All joint is body hurt badly.  Most joint pain subsided in a couple of week except joint pain in upper left leg on the inside of the leg, where the leg meets the torso.  That pain still bothers me today.  Hurts getting up from sitting.  Hurts getting out of bed.  Hurts if a turn my leg accidentally in the direction it does not like.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 05-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Info has been received from an RN concerning a 9 year old male with no known medical history or allergies who on 11/15/96 was vaccinated, in the left thigh, with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 11/18/05, the pt developed mild breakthrough chickenpox characterized by approximately 50 lesions in various stages. It was noted that the pt had felt "lousy" for 1 week prior to breakthrough. The pt was seen in the doctor's office. No lab diagnostic tests were performed. The pt was discharged from the doctor's office to home with symptomatic treatment and isolation for the duration of the rash. On 11/30/05, the pt recovered. There was no product quality complaint involved. Additional info is not expected.
child was administered a vaccine that had expired over one month earlier on 6/1/2022.
Treatment of COVID-19; Treatment of COVID-19; 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 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Jun2023 at 17:30 as dose 4 (booster), single (Lot number: GJ3268) at the age of 56 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Asthma" (unspecified if ongoing); "Other medical history: Bronchietasis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Knonw allergies: erythromycin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Feb. 23 eve. I had pains in the nerves in my left hip going down my leg and the left side of my tongue was sore. Feb. 24. I was very tired and achy all day with a bad headache. I had some nausea. I took Aleve but it didn't help much. I noticed when I went to bed that I had an open, bleeding sore on my right wrist. I knew that I had not done anything to hurt my wrist. Feb. 25. When I took a shower, I saw that I had an open, bleeding sore on my right shin. The right side of my tongue was hurting and sore. When I looked in the mirror at my tongue it had little red blotches all over the right side.  I have a bad headache but not as bad as yesterday.  I am also somewhat tired, but not achy.
3cm X 6cm , warm, red and tender area on right upper thigh; probable local reaction versus cellulitis. Treated with cephalexin. On 7/21/00-improving already.
after about 10 days of Moderna Booster, itcy hives all over the body. Becomes red and hot after a while. Have been moving around from neck to hand to legs to back. Getting sick of it.
Upon receiving the vaccine in my left arm, approximately 48 hours later,  LEFT AXILLARY LYMPHODEMA appeared. Described as  1/2 orange size/shape, warm to the touch.   Also significant swelling  left clavicular, into the neck, with one lymph node (normal size) firm and palpable along the clavicle.
Known patient to center here for covid vaccination present with father at 1030 Patient tolerated well vaccine and after waiting 30 minutes started to depart and states felt jittery at 1100. Patient resume in supine position with legs elevated. Patient states had not ate all day was going to lunch after appointment. Patient conversant and BP taken  Right arm 132/78 at 1105 VS @ 1110  BP 165/99 100 02 sat and 92 HR. Ice paks applied.   VS @ 1115 BP 148/96, 02 sat 99% 91 HR, Rep even 16 encourage deep breathing Patient drank juice x 2 , water and crackers without problems and felt better. Continue to monitor with Dr at bedside Patient HOB elevated in sitting position. Mother at bedside. Patient denies chest pain or difficulty breathing, denies  throat swelling or itchy. noted eyelid tremors when shut.  Discussion ensued on continued to monitor. Patient states feels better. BP 130/90 manual to right are.  149/101 Pulse 97, Resp 16 and even without problems at  1130. Patient amb in hall with assistance and tolerated well, no complaints. Patient escorted to car with out problems.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Aug-2020 and the estimated date of delivery was 08-May-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 01-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
This spontaneous report was received from a registered nurse via representative refers to 4 adult patients of unknown age and gender. Onan unknown date the patients were vaccinated with a dose of LIQUID PEDVAXHIB (lot#, expiration date and route not reported). No concomitant medications were reported. The patients received LIQUID PEDVAXHIB in error when they were supposed to get an unspecified Hepatitis B Vaccine. The patients were not experiencing any known symptoms. No further information is available. Additional information has been requested.
I received high dose flu shot in the afternoon of Sept. 21, 2017. About 3 AM on Sept. 23rd I woke up feeling sick and nauseous. All day and evening of the 23rd I felt nauseous, aches and pains, a fever of 100.8 and diarrhea. The same thing happened a year ago when I received the high dose flu shot.
Pain like arthritis in left arm, mainly in left forearm but the whole arm just feels weaker, especially when grabbing and lifting things.  Does not seem to be getting any better and not sure if it is getting worse started a week or so after last shot and has been consistent for the past month.  Plus I have had two episodes of cold sores on my lips within a month which is very unusual because I haven't had a cold sore in more than 5 years before I had this vaccine, so I was thinking my immune system might be weaker or something because of the vaccine allowing the cold sore virus to appear twice on my lips within a month.  Hopefully my arm gets better and I quit getting cold sores ASAP.
she got swollen glands; fevers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single and (Batch/Lot number: unknown) as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "she got swollen glands"; PYREXIA (non-serious), outcome "unknown", described as "fevers".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I slight soreness in my arm the next day. Then on the 27th of May, I started to having fluttering of my heart. I checked my smart watch and it alerted me I may have an Atrial Fibrillation event. I went to the Emergency Room and they drew my blood, chest X-Ray, and EKG. I was referred to my Primary Care Physician, a Cardiologist, and prescribed to me Xarelto 20mg. I was told to stop taking amlodipine, and also prescribed metoprolol 50mg.
PT stood up after receiving vaccines and having blood drawn for HIV testing. PT fell and hit the right side of his head and shoulder then began convulsing. Area was cleared to allow PT room to breathe and prevent any harm to PT. PT was sat upward after convulsing, then laid into lab chair. Chair was leaned backward to put PT's feet above head. PT was given water upon request, ice packs to cool down and fan turned on towards him to help cool down. PT was monitored for 15 minutes prior to releasing to battle buddy to be taken to clinic for further treatment. PT and event info was given to unit's PA.
This spontaneous report as received from a nurse 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 VAQTA (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed swelling/pain in lymph nodes of left armpit about 8 hours after vaccination.  At 10 hours after vaccination, developed chills and fever of 102.7.  Took Tylenol 650 mg every 6 hours for 48 hours.  chills and fever >102.7 lasted for 26 hours.  I could only manage getting up to bathroom and could not stay awake for longer than 15 minutes during that time.  Had fever of 101 for the next 24 hours while taking Tylenol.  Then had fever of 100 for another 24 hours.  The lymph node pain continued for a whole week with some swelling of lymph nodes in left armpit.
Redness and swelling of Left Leg after receiving Pediarix (DtaP-IPV, Hep B) on Left Leg on 2/6/20
DIZZY, SWEATS, CONFUSION, FEVER UP TO 102.6, BODY ACHES, HEADACHE, FATIGUE, WHEEZING, COUGH, NAUSEA SYMPTOMS STARTED 2/15 AND WERE WERE GONE ON 2/18
Shoulder pain on the left side where the Tdap vaccine was received. Severe skin reaction: itching, dark redness.
pt recvd vax & exp pain in rt big toe, rt thumb & rt hand; had redness of the rt hand; pain migrated to wrist & fingers of both hadns & ankles w/accompanied stiffness; MAR93 stiffness moved to include elbows; dx rheumatoid arthritis;
This spontaneous case was reported by a consumer and describes the occurrence of TREMOR, NERVOUSNESS, MOBILITY DECREASED, and FEELING COLD (head to toe felt cold) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 044A21A, and 022M20A) for COVID-19 vaccination.     Concomitant products included TERAZOSIN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced TREMOR, NERVOUSNESS, MOBILITY DECREASED, and FEELING COLD. In November 2021, FEELING COLD had resolved. At the time of the report, TREMOR, NERVOUSNESS, and MOBILITY DECREASED outcome was unknown.            Treatment medication include Advil or Ibuprofen  Patient reports after the booster shot on the first night the patient from head to toe felt cold, shaking and they eventually went away. Patient reports on the second night the patient was trembling from head to toe, like in a ice cold water for a long time but he wasn't actually cold and it lasted from head to toes, whole body trembled, very nerving, couldn't function, laid in bed shaking for a few hours. Patient talked to an HCP over the phone and they told him to take some Advil or Ibuprofen so he did. Patient reports that the nurse asked him to stay there after the shot for about 10 minutes and didn't tell anyone else so the patient was not sure if they gave him the full dose or not.