chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough COVID-19 infection. Tested positive on 08/04/2021. Patient fully vaccinated on 03/18/2021. Received monoclonal antibody infusion on 08/05/2021.
indication=Treatment of COVID-19; indication=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 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 at 13:15 as dose 1, single (Lot number: EW0150), in left arm, on 01May2021 at 13:15 as dose 2, single (Lot number: EW0176), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 25 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (25May2022) Negative; (31May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Anti viral details: Product COVID 19 Treatment, Paxlovid, she took 5 day course of paxlovid starting Wednesday afternoon 18May2022 through Monday morning 23May2022 for moderate COVID. Symptoms improved 20May and she tested negative Wednesday 25May On 28May she had a slight sore throat, 30May she became congested, 31May she had cooled mucus and tested positive for COVID again. Symptoms are more minor than initial infection.  No follow-up attempts are possible. No further information is expected.
PATIENT STATES SHE HAD SEVERAL SIDE EFFECTS AFTER HER VACCINATION.  FATIGUE DURING THE 1ST MONTH AFTER INJECTION AS WELL AS BODY VIBRATIONS AND PSYCHOSES.  JAN OF 2022 SHE WAS DIAGNOSED WITH ANXIETY AND INSOMNIA.  ALSO DEVELOPED HYPERTENSION, PALPITATIONS AND DYSPHAGIA AFTER HER 2ND DOSE AND STATES SHE WAS OTHERWISE HEALTHY PRE-VACCINES.  STATES SHE WAS HOSPITALIZED 4 TIMES IN 2022.
9 months after 1st dose, developed pain, weakness, swelling in left arm. Sx felt to be from worsening cervical radiculopathy and disc disease with cervical foraminal stenosis based on worsening cervical MRI. Surgery planned for December. However, due to my concern over pallor and supraclavicular swelling, went to a local ED and diagnosed with left subclavian DVT extending to the basilic vein. Diagnosed with venous and neurogenic thoracic outlet syndrome and later surgery followed by repeat clot and subsequent pectoralis minor release along with 5th thrombectomy. I do not think this is at all related to the vaccines but is new diagnosis. I did have left axillary tenderness and swelling after vaccine #1.
Acute peripheral neuropathy in lower extremities 4 days after 1st dosage. Metallic taste in mouth as well. Symptoms are still occurring constantly. Never had symptoms before.
Loss of hearing right ear, intermittent loss of hearing left ear lasting approx. 6 months.
3/5/21 emergency roomHPI  83 y.o. female who presents with  Complaints of nose bleed reports that she had a nose bleed this ongoing now for the past hour she could not stop at home and came for help she reports her symptoms are mild-to-moderate better with putting pressure on her nose worse without pressure denies any injury  FINAL IMPRESSION     ICD-10-CM ICD-9-CM 1. Hypertensive urgency  I16.0 401.9 2. Epistaxis  R04.0 784.7  2/22/21 Emergency room HPI  83 y.o. female who presents with SHORTNESS OF BREATH ONSET BEFORE ARRIVAL.  EMS GAVE PT A DUONEB AND NOW SHE STATES SHE FEELS FINE.  DAUGHTER STATES THAT PT HAD A YELLOW STOOL YESTERDAY.  PT STATES THE SHORTNESS OF BREATH IS WORSE WITH LAYING FLAT.  NO OTHER EXACERBATING FACTORS. FINAL IMPRESSION     ICD-10-CM ICD-9-CM 1. Acute urinary tract infection  N39.0 599.0 2. Shortness of breath  R06.02 786.05
her left arm hurt for a while; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her left arm hurt for a while) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her left arm hurt for a while). At the time of the report, PAIN IN EXTREMITY (her left arm hurt for a while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.   This case was linked to MOD-2021-292149 (Patient Link).
On Day 6, I started feeling tightness around the rotater cuff and inner arm muscle. On Day 8 I started feeling extreme fatigue and weakness. On Day 9 I started feeling extreme dizziness, as well as itchiness and raised rash on the injection site.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant and Treatment Drug was provided by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient was given the third dose at 5 weeks and 5 days after the second dose. No signs and symptoms noted.
Patient has had daily migraine headaches since 2 days after receiving vaccine.  Previous headaches were once a week and tension type, responded to tylenol.  After vaccine, headaches are daily and involve nausea and photophobia and do not respond to tylenol, but ibuprofen helps.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, the patient's healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Swelling in the face. Started to notice swelling around lips about an hour after shot. About 3 hours later swelling had spread to nose, cheeks, under chin, and roof of mouth. At 3 hours I took 2 Benadryl and 2 again about 5-6 hours later. Visually noticeable swelling was confined to the day of the shot. A week later I still have minor swelling, mostly around the lips.
Rash on abdomen developed - daughter first shows me day after 2nd Covid vaccine.   Rash has now lasted over 2 weeks.   Appears to be getting better.
She moved it to May 15 due to her colds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "She moved it to May 15 due to her colds".  Additional Information: Patient got the first dose last 20Apr and second dose was scheduled on 11May however patient moved it to 15May due to colds and now patient wants to move it a week after 15May.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Burning in lips ,heart palpitations, now there is burning over her entire body with neuropathy and has to use a walker now
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information about patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB, lot # L048236, expiry date: 31-MAR-2018 (dose and route not reported). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
On day 2 following the vaccine began to have the following symptoms:  Fatigue, disorientation, increased pulse, numbness and tingling on left side of body  and symptoms continue to come and go as of 1/28/2021.
Per patient event occurred after leaving the pharmacy and going grocery shopping.  Per patient report felt like it was more difficult to swallow when sipping her sweet tea and  that her throat may have been swollen.  Patient reported upon this realization that she then examined her face in a mirror to realize that her "left gland," on the side of her face, was swollen looking.  She reported going home and taking 2 Benadryl's and feeling better after about an hour.  Patient reported not having any more adverse events since that incident.
Information has been received from a health professional concerning a 23 week old female who on 12-MAR-2008 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (rHA) (Lot #657629/1482U), along with Hib conj vaccine (OMPC) (Lot # 655546/0075U) both of which were drawn up in the same syringe and administered intramuscularly into the right thigh. There were no problems reported. It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY), on 21Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures taken as a result of vaccination failure, covid-19 included administration of Paxlovid from 21Feb2023 to 26Feb2023.
INJECTION SITE LOCAL REACTION (REDNESS/HOT TO TOUCH/SWELLING) & LOW-GRADE FEVER THAT RESOLVED A FEW DAYS AFTER INJECTION , BUT THEN RETURNED APPROXIMATELY A WEEK LATER. LOCAL REACTION ALSO RECURRED APPROXIMATELY 4 INCHES FROM ORIGINAL INJECTION SITE.
He did not have an adverse reaction for 1st and 2nd doses, only for the 2 boosters.  On October 5, 2021, Booster #1 was administered, and the next day, October 6, 2021, he fell in the bathtub while showering, and was incoherent for a time, so the ambulance took him to the ER.  He was diagnosed as having a seizure.  Then, on May 4, 2022, Booster #2 was administered,  and he had another seizure, on May 5, 2022, requiring an ER visit.  The doctor then increased his seizure medication.  His seizures leave  him with no muscle strength in his arms and legs and he becomes dead weight.
22MAR94 from MTR states pt had erythema multiforma from MMR; states it started 5AUG93, seen by MD & 2 dermatologists who feel its from MMR: red spots still come & go & are usually on childs legs;
24 Sep 2021- Day after shot, fatigued and severe headache.  2nd Oct 2021 - A week later noticed red spotty rash on inoculated  Arm, rash has since subsided as of 5 Oct 2021
Knot on leg from injection a week after shot. Swelling and pain on (R) back of thigh, hard, firm, red swelling/bruising of around 2cm by 2cm. DX with vaccination reaction swelling, treated with TYLENOL/MOTRIN/ice.
Missed second dose of Covid-19 vaccine on 17Apr2021; one week later I was positive for Coronavirus; Fever; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration, administered in left arm on 27Mar2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy (allergies 5 years ago). He reported that he was supposed to be getting the allergy injections for 3 years to be immune because allergy season was really bad for him, especially with pollen. He reported that he gets allergy injections every week in his arms. Concomitant products allergy injections: he began getting weekly allergy injections about 18 months ago. No Additional Administered Vaccines. No adverse event following prior vaccinations. On 07Apr2021, the patient experienced fever. On 08Apr2021, one week later he tested SARS-CoV-2 test: positive. He had a phone consultation with his physician after testing positive for Covid-19. He was supposed to be going for his second dose on 17Apr2021. Patient missed second dose of Covid-19 vaccine. He asked my doctor and she said she didn't know when he could get his second dose. They told me him had to call Pfizer. He missed second dose of Covid-19 vaccine. The events assessed as non-serious. On 10Apr2021, the event fever was resolved. On Monday, 19Apr2021, he went to get checked again for Covid-19 and he tested negative. He reported that he just recovered from the coronavirus last week. The outcome of the event tested positive for coronavirus is recovered on an unspecified date in Apr2021 and fever was recovered on 10Apr2021, missed dose was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
8 days after receiving vaccine got 8X9cm swelling at injection site that was puritic
Contracted symptomatic covid after vaccination; Contracted symptomatic covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (COMIRNATY), on 24Feb2021 as dose 1, single (Lot number: EL3247); on 17May2021 as dose 2, single (Lot number: EL3247); and on 03Nov2021 as dose 3 (booster), single (Lot number: EL00217) at the age of 37 years, all intramuscular 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) all with onset 30May2022, outcome "recovering" and all described as "Contracted symptomatic covid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Negative, notes: Nasal Swab; (Jan2022) Negative, notes: Nasal Swab; (Mar2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: There was no other vaccine in four weeks. There was no covid prior vaccination. However the patient tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
red, hot to touch, 2cm wheal w/10cm erythema;10 yr booster;resolved 11SEp95;
Member c/o body aches and fever - 24 hours post vaccination actual temperature  unknown. Patient c/o sudden onset of a chest cold and c/o he is sneezing blood tinged secretion. Did not seek treatment at this time.
Case number PHEH2015US020477, is an initial spontaneous report from a nurse received on 12 Oct 2015. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1515201) intramuscularly that experienced an unknown temperature for up to two hours during a power outage on 12 Oct 2015. No adverse event was reported.
Extremely heavy periods since vaccination with large clots. This is very unlike anything I have ever experienced (bleeding through tampons and pads in under an hour) blood clots the size of golf balls. This is my 3rd period like this.
received quadracel in error at age of 2 year (age range for Quadracel was 4-6yrs of age)/no AE; Initial information received on 16-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 year old patient who received quadracel in error at age of 2 year (age range for Quadracel was 4-6yrs of age), while he/she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot number not reported via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  A health office received a Quadracel vaccine. The age range for Quadracel was 4-6yrs of age, which means this child received Quadracel in error.  At the time of report, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
1000 Pt to gym to receive flu vaccine. Form reviewed, pt states she has allergic reaction to "sulfic drugs/preservatives" Pt states that she has had previous doses of flu vaccine without any problem. states she had a headache after receiving her COVID vaccine.   Vaccine administered in Left deltoid by RN. Approximately 1020 school nurse called stating that pt is complaining of "tingling in left arm and left side of tongue" Pt walked back to gym without difficulty. Vital signs were taken BP 122/93 P 98 Lungs clear. Pt states she had hives "but you can't see them, they are on the inside" C/O nausea, sweating EMS Notified. School nurse administered 25 mg of liquid Benadryl per pt request. pt
Received the booster on Thursday afternoon.  Sore arm that evening.  Friday, Saturday, Sunday, I had typical symptoms that many people describe:  slight fever, aches & stiffness on the shot side, tenders in the lymph nodes, generally feeling cruddy.  But, starting Monday, I developed the same symptoms I had after my second shot:  extreme lethargy, accompanied by lightheadedness.  The lethargy is as if someone draped 3 dental x-ray aprons on me all day and all night.  Hard to walk, had to shuffle my feet and hold on to the wall to stay up right, and that's not normal for me - I normally walk at a brisk pace fully upright.  This lasted for 14 days, followed by 14 days of extreme version of seasonal allergies - persistent headache, dizziness, sinus pressure, fatigue, and brain fog.   I've never had allergy reactions like this and I relate it to the booster; it felt like one big reaction.
Missed the 42 day window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the 42 day window) in a patient of an unknown age and gender 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 PRODUCT DOSE OMISSION ISSUE (Missed the 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the 42 day window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No Treatment medication was provided.
Initial unsolicited report received from a physician on 29 May 2015. A 67-year-old male patient, whose concomitant medications were not reported, had received an second injection of ADACEL (batch number and site of administration were not reported) via intramuscular route on 20 May 2015. Patient's illness at the time of vaccination involved lacerations and injuries due to car accident. Pre-existing physician diagnosed allergies, birth defects, medical condition was reported as "none chronic back". Patient had received ADACEL vaccine only previously 2 months prior on unspecified date. On 20 May 2015, same day after vaccination, the patient experienced arm pain. It was vaccine administration interval too short. Laboratory investigations were reported as none. Corrective treatments were not reported. Patient required ER/doctor visit. And the patient was advised to see a neurologist. At the time of this report, the patient was not recovered from the event. Documents held by sender: none.