chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flareup after 2nd and 3rd doses. Flareups keep getting worse causing me to start Orencia from an unspecified date to 02Jul2022; Flareups keep getting worse causing me to start Orencia from an unspecified date to 02Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 08:15 as dose 2, single (Lot number: EL8982) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Linear IGA Dermatosis" (unspecified if ongoing). Concomitant medication(s) included: DAPSONE; HYDROXYCHLOROQUINE. Past drug history included: Enbrel, reaction(s): "Known allegy: Enbrel". Vaccination history included: BNT162b2 (Vaccine administration time: 09:15 AM, Vaccine lot number: EL3247,, Vaccine lot unknown: False,, Vaccine dose number: 1, Vaccine dose number unknown: False, Vaccine location: Left arm), administration date: 19Jan2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Covid-19 Treatment", "Covid-19 Treatment". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flareup after 2nd and 3rd doses. Flareups keep getting worse causing me to start Orencia from an unspecified date to 02Jul2022"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "Flareups keep getting worse causing me to start Orencia from an unspecified date to 02Jul2022". The patient underwent the following laboratory tests and procedures: Body temperature: (04Jul2022) 102, notes: tested positive 04Jul2022 with 102 fever; SARS-CoV-2 test: (04Jul2022) Positive, notes: tested positive 04Jul2022 with 102 fever; (13Jul2022) Negative, notes: Tested Covid negative on antigen test 13Jul2022; (14Jul2022) Positive, notes: tested positive on antigen test 14Jul2022. Therapeutic measures were taken as a result of rheumatoid arthritis, condition aggravated.  Clinical course: The patient received other medication within 2 weeks of vaccination. The patient received the Anti-viral drug (Plaxovid) as COVID 19 treatment from 05Jul2022 to 10Jul2022. Rheumatoid arthritis flareup after 2nd and 3rd doses. Flareups keep getting worse causing patient to start Orencia. COVID symptoms began 03Jul2022 and tested positive 04Jul2022 with 102 fever. Tested COVID negative on antigen test 13Jul2022. Respiratory symptoms began evening of 13Jul2022 and tested positive on antigen test 14Jul2022.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966412 Same patient and event, different dose;US-PFIZER INC-202200960651 Same product, patient, different AEs, different dose;
Pt reported back to pharmacy ~15 mins after shot complaining of eye burning, watering and itching. Bilateral itching on arms. No impact on breathing/chest. Administered 50mg Benadryl and pt sat for 15 more additional minutes. Left on their own and stated symptoms were improving. Advised to stay in store a bit longer just in case. Will f/u in 3 days. Shot 1. Advise caution with shot 2.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX. On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, muscle pain, chills, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the muscle pain, chills and fever were recovered/resolved. The reporter considered the injection site erythema, muscle pain, chills, injection site swelling and fever to be probably related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional reported that at evening of the vaccination day, the reactions started to appear. The patient experienced redness, swelling at injection site and surrounding area. The patient also experienced fever, chills and muscle aches. All of the symptoms had resolved except the redness and swelling at the injection site. No additional information was provided.
I have had hives every day. They started two or three days after. They have not gone away. Nothing new has changed in my life. There is no new laundry detergent. These hives are like what I get when I have mushrooms. I have never gotten hives otherwise.
No adverse event; Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 27-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023).    No concomitant medications were reported.  No treatment information was provided.
Vaccine stored in refrigerator beyond 30 days when administered. During follow-up, patient  reported sore arm. Advised repeating dosage.
On 8/6/99, the pt became dizzy while eating lunch. The pt also experienced lightheadedness and almost passed out. The pt also experienced weakness and spent the remainder of the day in bed. A headache, fever and weakness occurred. The symptoms resolved the following day.
Confusion, Myalgia, Arthralgia, Fever, Fatigue, dyspnea Narrative:
Very sore L/arm, increased temp, felt achey throughout body, felt like arm locked up, very stiff in joints. Redness & swelling site of shot. Did no notify office of this until returned for 2nd HEP-B shot. Feel this is rxn to TD, in L/arm.
Pt experienced heart pain, joint aches, and initially severe muscle pains. All symptoms subsided after approximately 2 weeks.
Patient came in to get Moderna vaccine. After 5 mins of the vaccine being administered, vaccine stated they feel dizzy and nauseous, she started to faint and I along with her husband caught her before she fell to the ground and no injury was seen. She was stabilized but was still not feeling well, thus, paramedics were called in to assess and evaluate the patient. She was taken to the closest hospital.
My daughter had a severe reaction to her first GARDASIL injection, but she had a flu shot the same day, so we thought she was reacting to that....achy, burning pain up and down her arms and legs. 2 months later she had her second GARDASIL injection and had a similar, but more severe reaction. She begged me to cut her arms off because the pain was so bad, and she said that each arm felt like it weighed 1500  pounds! She is normally a pain-tolerant teenager and not whiny about a little pain, so I knew it was a major deal. We are not planning to get the 3rd injection, as I have no intention of seeing her go through that, or worse, again! Her symptoms only lasted 24 hours.
pt described by parent as having high fever followed by grand mal sz activity lasting less than 1in;also has erythema @ site of DTP/HIB inj rt thigh;
Moderna COVID?19 Vaccine EUA Received 1st vaccine Dec 29, 2020, received 2nd vaccine while unknowingly pregnant on January 27, 2021. Had chills, fatigue, body aches night of 2nd vaccination. Found out pregnant Feb 7, 2021 at 4 weeks pregnant. Had blighted ovum/anembryonic pregnancy with miscarriage March 12, 2021.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had a stroke affecting the left side on May 17, 2022. Not in a risk category for stroke.
mom states pt has cried from 1130AM -4PM w/an abn cry-feels warm but hasn't taken temp @ time of call;
Severe exacerbation of myalgias in lower extremities > upper extremities, described as "cramps", gradually resolved over several weeks
His arm was sore almost immediately, within 10 hours he felt fatigue, by the 2nd day he started coughing, loss of appetite, couldn't sleep, within the first week his cough worsened and he said his chest felt pressure. His stomach wasn't well and he had diarrhea. He wasn't getting better. By second/third week he was saying his ankles hurt and I noticed he was walking strange. I noticed he wasn't eating well and was still coughing a lot. He got his second shot and was sick very fast, within hours. All the same symptoms, but worse. Very tired, coughing worsened and his walking was getting bad. During the next couple weeks I noticed he was gaining weight but couldn't think why if he wasn't eating well. He spent most of  He spent most of his time sleeping. By the third week after the 2nd vaccine he was acting out of character, talking out loud to no one and not making sense, standing at a cupboard and just staring for a long period of time. He was having bathroom accidents and not aware of it. I was questioning him and he wasn't sure. He came down in morning and his face was swollen and I brought it to his attention. The day he went to health clinic, March 27, 2021, he had come downstairs and said he felt like a truck hit him, his breathing sounded terrible and I got him an appointment immediately. So at health clinic, they found he had tachycardia and we took him immediately to the emergency room March 27, 2021. After some testing they found he had a blood clot in his heart, left ventricle, and in both lungs. He needed further testing and his condition was worsening, he was in heart failure, so they put him on blood thinners and transferred him March 28, 2021, where he was put in ICU and had a echocardiogram. He was treated there for a period of time. For some reason he was transferred into a Cardiac unit. His condition did not get better, he had a stroke. They found he had small clots in his brain. He lost some control of his right hand and couldn't pick up things or use his fingers well. He went back into ICU. We were told he needed further treatment and was transferred to ICU April 3, 2021 and after testing and treatment, where they found he was allergic to heparin, he had surgery to have a LVAD placed, April 9, 2021.  Patient is currently under the LVAD Team's care. He is in the process of going on the Heart Transplant list.
Incorrect vaccine for age--patient given first dose Moderna in error on 3/9/21, so given second dose Moderna on 4/19/21 as per CDC guidance.  No AE.
I didn't feel well few days after the vaccination. On 11/24/2014 I continued to feel even more fatigued and not well. When I saw my doctor, she states my water broke and I was rushed to ER at hospital. The infant in-utero did not survive.
t102 on day of vax pt very irritable difficult to console for 2 days; recvd DT on 25NOV92;
I was fine until about 10:00 pm that night.  Started with chills and body aches.  Then my arm where the injection was, became extremely sore.  I was in bed all day the following Saturday and Sunday.  I had covid and it was almost as bad as the virus .
A half hour after the third series " I started getting dizzy and nauseous.  I got ringing in my ears, which I still have.  It is worse at night, but has gotten slightly better."
The patient stated he woke up Friday morning with severe cramping in the arches of his feet and traveled up to the calves. It was so severe he had trouble straightening out his foot. The cramping traveled up his body in his torse and legs. It lasted two full days
hives on forehead with upper lip swelling within 30 minutes NO EPI or benadryl given resolved in 30 minutes
BODY ACHES; SORE ARM; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAR-2021 (vaccinated on left arm) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced headaches. On 14-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and the outcome of headaches, sore arm and nausea was not reported. This report was non-serious.  Additional information was received from patient on 19-Mar-2021. The following information was updated and incorporated into the case narrative: (Patient gender and dosage text (in narrative only) was updated).
Pain beginning at the deltoid for 1 week, and then radiating down the arm for 2 additional weeks.
A nurse @ clinic reported that several recipients of Td exp nausea & vomiting following immun; No details available @ this time;
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1807USA003055: US-009507513-1807USA003054: US-009507513-1807USA003053: US-009507513-1806USA012857: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
One day post vax, the pt experienced severe pain in her left deltoid muscle and shoulder. On a scale of 1-10 the pain was a 6 during the day and a 9 at night. She was unable to sleep on her left arm. She has not had any medical follow-up nor has she taken any medication to treat the pain. Engerix B was discontinued. The most recent information received reports the outcome of the event is unresolved.
edematous lt parotid gland, tender to touch; T(ear) range 101-104; rx Advil susp 1/2 tsp q 4 hrs PRN T>100, inc fluids as tolerated;
PRURITIS, HIVES ON FACE, BACK, GIVEN BENADRYL 50mg im for the hives. Given 25mg oral cap QID.
Passed out approximately 6 hours after receive COVID-19 injection; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:30 (lot number: ENU204) at the age of 77 years old, as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies. No other vaccines received four weeks prior to COVID vaccination. The patient took other unspecified medications two weeks prior to COVID vaccination. The patient passed out approximately 6 hours after receipt of COVID-19 injection on 18Mar2021 16:00. There was no warning, dizziness nor weakness of the knees, prior to passing out. The patient landed on his forehead (out less than a minute). There was no reoccurrence. His wife had shot same time, no effects. No treatment was received for the event. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the event on an unspecified date.
mom states pt had a fever of 105; & wouldn't stop crying; had given pt APAP;
With first and second shot I got sick that lasted 2-3 days, I felt tired and ached all over and had a headache. On the third dose, I came home, the next day I felt brain foggy and felt sluggish. I had a headache, and I took Motrin, and it went away. So, what happened ever since then I have been foggy, almost like my brain is closed in, it is so hard to explain. And dizziness, it is not getting better, I said to myself I thought I had COVID-19, but I have never been sick. I had the sniffles, and it was from flowers in the house and tested for COVID-19 twice and they came back negative. I got all the shots within the recommended schedule. I saw my doctor and I had bloodwork that came back great, I even changed my diet thinking it was something I ate. But everything came back great no diabetes, cholesterol everything was good. My doctor sent me to an ENT and I have an appointment on 04/28/2022 to see if it is vertigo.
Right arm swollen, hot, hard to the touch 11 1/2" long and 18 1/2" wide. Itchy and painful.
Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's sister. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
experiencing bad ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (experiencing bad ringing in both ears) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030m20a and 042l20a) for COVID-19 vaccination.     Concomitant products included LOSARTAN and METOPROLOL for an unknown indication.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced TINNITUS (experiencing bad ringing in both ears). At the time of the report, TINNITUS (experiencing bad ringing in both ears) had not resolved.            Treatment medication included lipo flavonoid Action taken with mRNA-1273 in response to the event was not applicable
This case was reported by a healthcare professional and described the occurrence of red spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (.5 ml, unknown route and site). At an unspecified time after vaccination with FLULAVAL, the subject experienced red spot at injection site and itching. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 5 out of 70 subjects who received FLULAVAL experienced the events as noted. The facility used a single dose syringe vaccine last year and did not have any complaints of this nature. This is case 5 of 5 (see case IDs A0885547A, A0885964A - A0885966A for the other reports).
Vaccine #1 01/27/2021 Pfizer, Lot # EL3249  Pt currently has covid 19
Neuropathy down the back of the injected arm that radiates to the elbow and down the forearm to the pinky and ring finger of the left arm. Started within 30 seconds of injection and has not subsided after 4 hours; ongoing.
about 15 minutes after the vaccination the patient began to feel like her throat was closing up with some difficulty swallowing and itching inside throat, difficulty tolerating water - also feeling nauseated. has similar reactions when she eats seafood which usually resolves after taking antihistamines. pt was given IM Benadryl by ALS crew on site with improvement in symptoms about 5 minutes after medication given. symptoms improved and then resolved with ~ 45 min of observation and she went home