chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is otherwise healthy.  Five days ago the patient received his MMR vaccine and DTaP.  Four days ago the patient's fever began.  Three days ago the patient's fever became higher to 100 to an a patient felt ill. He had a rash that began around the injection site. The rash was itchy. He also had a mild runny nose that was clear and requiring tissue. But he did not have a cough or a sore throat.  Yesterday the patient was seen in his pediatricians office. He was negative for all of the following: COVID-19, influenza, and strep throat. His hematocrit, platelets and granulocytes were mildly high, Pediatrician was unsure of the diagnosis or the ideology.  Last night the fever was 102 and patient complained of headache.  Today, the patient is doing better and that he feels better. He is eating and drinking but not as much as he usually does. His runny nose has resolved. His fever tonight is lower, in the upper 99 range. However his rash persists as in the photographs and is itchy. Patient has had no diarrhea to suggest Coxsackie virus.
Pt recvd vax & exp hypothyroidism which was treated w/Synthroid;
Fever, uncontrollable shivering, Nausea - lasted for approximately 6 hours, then headache for 2 days.
vaccines Tdap and Meningococcal were given in the left arm, and then influenza and HPV in the right arm. HPV was given last. Patient slumped forward less than one minute after receiving the HPV and had fainted. No injury came of this. Nurses safely repositioned to laying down on her back with legs elevated and she came to in two minutes or less. Vitals were obtained and appeared stable. MD was notified of incident and came to assess patient and deemed it safe for her to continue home after a few minutes.
wasn't able to roll over on top of his arm; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Lot number: EN4204) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (ongoing), notes: he exercises a lot but doesn't eat right. Cholesterol was pretty good until about 2-3 years ago. Concomitant medication(s) included: TETANUS VACCINE taken for immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "Sore arm"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "wasn't able to roll over on top of his arm".  Additional Information: The patient was on cholesterol medication as his cholesterol got bad 2-3 years ago. Patient reported that, he felt his sore arm before he left the store and he wasn't able to roll over on top of his arm. He also reported that the sore arm lasted for a day or two, matter of fact about a day. Patient works out a lot. Patient reported that, his doctor said that he works out too much. He exercises 1 to 2 hours daily except for Saturday and Sunday. It was reported that, additional administered vaccines were none. Adverse event did not result in emergency room visit or physicians office visit. It was reported that, the patient received Tetanus shot a month or two before the first dose of the Covid-19 vaccine. There was no family medical history relevant to adverse event. No adverse events following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
11/02/22 presents to ED for "shortness of breath and cough". PMHx of "HLD"
Initial report received from healthcare professional on 2 April 2014. A '52-year-old female patient', had medical history of headache from 23 March 2014 to 31 March 2014, and concomitant medication of AUBAGIO 14 mg daily from 21March 2014 due to the possibility of Lyme disease, and ibuprofen as needed were reported, had received dose of Tetanus Toxoid (Lot number, expiration date, route and site of vaccination was not reported) on an unspecified date due to two ticks bites on 25 March 2014 and 27 March 2014 and had experienced right shoulder hurting. The laboratory details and corrective treatment were not reported. The outcome of the event was unknown at the time of report. List of documents held by sender: none. Follow-up received on 29 April 2014. No new information was provided.
Vaccine brand: Pfizer/BioNTech/Vaccine dose number: 4; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 11Sep2022 at 11:30 as dose 5 (booster), single (Lot number: AS7148B), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Lot number: 002A21A), on 02Apr2021 as dose 2, single (Lot number: 046A21A) and on 12Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech/Vaccine dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2022) Negative, notes: COVID rebound after testing negative on 10Dec2022 and 11Dec2022; (11Dec2022) Negative, notes: COVID rebound after testing negative on 10Dec2022 and 11Dec2022; (18Dec2022) Unknown results, notes: I retested on 18Dec2022 due to runny nose, sneezing, and cough symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID rebound after testing negative on 10Dec2022 and 11Dec2022. I retested on 18Dec2022 due to runny nose, sneezing, and cough symptoms. The patient had no known allergies.
he tested positive for Covid-19 infection last 11Jun2021; This is a spontaneous report from non-contactable consumer (patient) and sponsored program via information team. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 05Jun2021 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were none. On 11Jun2021, patient tested positive for Covid-19 infection. Patient haven't been hospitalized ever since getting the vaccine. Patient stated he was scheduled for his second dose of vaccine on 26Jun2021. Patient stated that he believes he may have had Covid when he got his first dose of vaccine. The patient underwent lab tests and procedures which included COVID-19 SARS-CoV-2 test: positive on 11Jun2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
2/17/21: slight burning sensation on skin; itchy eyes 2/18/21: itchy eyes, sore deltoid, sore rt hip, sore 1st rt finger 2/19/21, 2/20/21: sore under rt upper arm 2/21/21: greater pain under rt upper arm, took acetaminophen 2/22/21-3/7/21: pain extending from rt underarm to rt wrist upon extension/reaching 2/24/21-2/26-21: rt carpal tunnel ache 2/28/21: lymph nodes not as sore 2/28/21-3/11/21: puckered skin, rt upper arm
This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose and influenza vaccine at unknown dose, both via an unspecified route of administration on 05Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. On 06Nov2016 she went to the pharmacist with big rash on her arm, chest tightness and pain, fever, body ache, she was like in tears and she felt very bad and felt like she got Pneumonia. Pharmacist further described adverse events as chest pain, difficulty breathing and back pain as well. The outcome of all events was unknown. A product complaint was filed. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the known adverse event profile and on the temporal relationship. The Company however considers the administration of a concomitant vaccine an important confounder in the independent assessment of the causal relationship. 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.
Employee called 6/30/23 and stated she was achy, sneezing and diarrhea with a temp of 99-100.  She also said she felt like her chest was in a grip.  Employee called to because she wanted this on her record.  She stated she had side effects from MMR #1, which she told the nurse who gave her the injection on 6/28/23.  She was offered the opportunity to apply for a medical exemption which she declined and consented to receive the second MMR on6/28/23.
Pt reported blisters on the vaginal and rectal area. Pt experienced pain, itching, burning and tingling.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 27-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
She had a whelp on her arm about 2 inches in diameter.  she said she had been throwing up since she got the shot.  She stated her arm hurt very much.
After my first vaccine I developed headaches, back pain, muscle pain and joint pain. I also got tested for Covid-19.
Flushed, red: head to toe urticaria in 2 hours taken to ER: given epinephrine, antihistamine and steroids. Did complain of itching today 12/06/2004 at 6:30 am.
Ten hours after vaccine I experienced a hyperglycemic  event; my glucose was so high than neither my arm sensor (Free Style Libre) or my finger stick meter could read it.  It took 40 units of Humolog over a 2 - 1/2 hour time period to bring it down enough to read it.  It was 452.  By morning, six hours later and 20 more units, I am down to 236.  My systems started with my heart pounding out of my ears and neck, frequent urination, and sweating or feeling warm (usually associated with low blood sugar events).  I ate lunch after the vaccine, but by evening when I would normally make some dinner, I didn't eat until I forced myself to eat some cooked cauliflower at 12:30 a.m.  As I was finally going to bed, around 2 p.m., the cough started.  The cough is an itch at the base of my throat with a slight feeling of swelling.  I have sugar free cough drops and cinnamon candy (which helps reduce the swelling).  This morning, four hours later, the cough has a small amount of phlegm with it (but mostly just itches).
patient was inadvertently administered a second dose of MENQUADFI, seven days after he received a dose of MENQUADFI with no adverse event; patient was inadvertently administered a second dose of MENQUADFI, seven days after he received a dose of MENQUADFI with no adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was inadvertently administered a second dose of menquadfi, seven days after he received a dose of menquadfi with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Sep-2022, the patient received 0.5 mL of dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation, strength and lot number not reported) via intramuscular route in the right deltoid for immunization. On 19-Sep-2022, he also received 0.5 mL of dose 2 of the same vaccine (formulation, strength not reported; lot U7218AA and expiry date: 22-Feb-2024) via intramuscular route in the right deltoid for immunization.   On 19-Sep-2022, (latency: same day) the patient was inadvertently administered a second dose of menquadfi, seven days after he received a dose of menquadfi with no adverse event (accidental exposure to product) and (inappropriate schedule of product administration) following the 2 dose administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
had two shots, still got the shingles; shingles, nasty; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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. 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 by patient. The age at vaccination was not reported. The patient had the two shots and still got the shingles the beginning of December. The patient stated that nothing was guaranteed and nasty. The case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not reported. Note: The year of event onset was not provided hence it was not captured.
pt recvd both injects 13MAY93 approx 3PM; began to feel bad 2AM; chills inc; had n&v, fever 100.4; c/o both arms sore, sl redness;
o Chief Complaint Pt is an 85 y/o female presenting to the ED by squad with c/o nausea, body aches, and feeling bloated s/p receiving her first COVID-19 vaccine shot yesterday. Pt states that she felt fine up until last night. Pt denies HA, dizziness, lightheadedness, CP, SOB, cough, V/D, abd pain, urinary complaints, fevers, chills, or rashes. PMHx includes COVID-19 pneumonia in December.
On 3/2/99, approximately 2 hours post vax, the pt experienced lightheadedness, loss of appetite, and light nausea, along with fever and chills. Eight hours post vax, the pt noticed a rash on both of her forearms. ON 3/3/99, she experienced accelerated heart rate and visited the MD. The MD ordered the pt not to continue with the rest of the Hep b vaccines series or any other vaccine. Also, the MD recommended that the pt should follow up with an allergist.
Received vaccine at 4:00 pm on 4/28. Approximately 10 hours later, I woke up in early morning hours of 4/29 with muscle pain, mostly in my arms (even in non-vaccinated arm). Went back to sleep. Woke up a few hours later for the day feeling very ill. Headache, body soreness, fever, and lethargy. Took temperature with a digital thermometer throughout day. Temperature ranged from 99.6 to a high of 100.1.  Today, 4/30, (approx 42 hours after vaccine), my temp has hovered around 99.5. Still experiencing headache and lethargy. However, I feel better than yesterday. Have treated fever and pain with Tylenol.
Swollen, warm arm within an hour of administration. Came back to clinic the next day, advised to ice, take benadryl, and follow up with PCP.
Facial flushing, shortness of breathe, elevated blood pressure (155/115), chest tightness, hives on top half of back Received benadryl, steroid, pepcid, aspirin Breathing eased, blood pressure came down.  Had to continue treatment for 5 days
I developed subcutaneous hematomas/large circular bruising on both of the tops of my thighs about 5 days after the 1st vaccine. Has this ever been reported by anyone? Bruises went away in about 3 days.
Patient call 6 days post shot to inform pharmacy that her arm still hurts. Under her arm hurts and there is a lump under her arm.  Counseled patient to take pain reliever and  put ice pack on area to help.  told her to see  Dr, but she will watch to see how it goes.  Just wanted us to send info of her symptoms.
Began feeling very ill one day after vaccine.  Had severe headache, body aches, fatigue.  Soon after I developed weakness and numbness in lower legs and feet.  This has continued and not let up.  I have had dizziness, difficulty sitting or standing up for long periods of time.  Had severe pain in legs.  Had to lie in bed most of the time.  Anxiety, shakiness, difficulty sleeping also progressed.  Had extreme fatigue and continued feelings of being ill and light headed.  The numbness and pins and needles in feet continue.  Cannot walk for long periods, very limited in my ability to do anything physical.
Rednes and Pain at injection site, increasing in size.  Cramping in stomach with meals.    Cellulitis Left Arm.   Keflex EQ 250mg 4 times daily X10 days.
Patient reported tongue swelling within 30 minutes of vaccination.  Resolved without treatment and was released to home.
Cerebellar ataxia,  fever 103, severe headache 10 days after covid vaccine.
Feeling of dehydration. Bounding pulse. Throbbing headache. Mild fever. Nausea. Muscle aches all over body. Chills. Duration of these symptoms was approximately 12 hrs.
1st dose 11Jan2021, 2nd 08Feb2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number FA277, expiry date 27th May 2024) for prophylaxis.   Previously administered products included Shingrix (on 11th January 2021 received 1st dose).   On 8th February 2023, the patient received the 2nd dose of Shingrix. On 8th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The pharmacist called to inquire that does the patient need to restart the Shingrix series. The reporter reported that the patient received the first dose of Shingrix back on 11th Jan 2021 and just received the second dose today on 8th FEB 2023. The reporter did not consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Patient reports to LHD today with mild edema in ankles and feet.States that edema is greatly improved since initial onset on evening of vaccine administration.Vaccine was given between 4:30-5 pm.Patient states acute onset of edema noticed at bedtime.States swelling was enough to make legs and feet hurt.
Blotchy rashes all over his face, around eyes, lower abdomen.  Swollen face.
2wk p/vax pt stated that could not sleep & exp bad dreams, severe h/a & an earache;stated that felt like was dying;did not report these sx to MD;
Hives at site of injection, L shoulder measuring 10cm x 6.5 cm erythema induration.  Onset ~24hrs following injection.
Bilateral medial epicondyle pain, right thumb pain, two weeks later, left foot pain started, 2 weeks later, bilateral knee pain started.
BIVALENT VACCINE WAS GIVEN TWICE. RESIDENT RECEIVED BIVALENT DOSE ON 11/3/2022, THEN AGAIN ON 2/2/2023.
1 mo post vax pt has blister like leisons on L arm at inject site. Area of red and blister like skin 15 mm on L deltoid. Comes and goes, itches, no pain.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 24May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penecillin" (unspecified if ongoing). There were no concomitant medications. The patient had no other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment for covid-19 test. 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.
ON 1/22/21 DEVELOPED REDDENED AREA AT INJECTION SITE
felt a bit feverish; arm is a bit sore; This is a spontaneous report from a contactable consumer (patient herself). A female patient Age: 64, Unit: Unknown received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In 2021 patient reported that patient couldn't scan the code when she got the first shot of the Pfizer yesterday. The women who was there said it's fine you don't need to. She felt fine after getting her shot. And felt a bit feverish and checked her temperature it was 98.1 which was fine. The patient arm is a bit sore. She heard on (website name withheld) all kinds of negative stuff. They are saying we don't know what's in the Pfizer vaccine. Is it poisonous? Could people die from it? The patient was bit a skeptical about the shot. She spoke to her doctor. She advised her to get the vaccine. The events reported are non serious. The patient underwent lab tests and procedures which included body temperature 98.1 in 2021. Therapeutic measures were taken as a result of felt a bit feverish she took an extra strength Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 2/19/13 vaccine TENIVAC adm. Pt said arm sore for 2 or 3 days. On 2/26/13 arm started itching a lot. Red and swollen at site.