chrisvoncsefalvay/vaers-outcomes huggingface dataset:
peripheral vision has been blurry; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Right on 29Jan2021 (at the age of 75-years-old) as dose 1, single for covid-19 immunisation.  The patient medical history was not reported. The patient experienced peripheral vision has been blurry on an unspecified date. Patient received his 1st dose of the Pfizer Covid Vaccine 3 weeks ago and stated that for the last couple of weeks his peripheral vision has been blurry. Wants to know if there are any reported vision issues with the vaccine and if it's recommended for him to get his 2nd dose tomorrow because of this. Second dose was scheduled for the next day. Patient stated that in the last couple weeks, it seems like his peripheral vision is blurry, like it is not clear. Patient did not know if this is a coincidence or what, but he is wondering if Pfizer is aware of any incidents of something like that happening with the vaccine. Patient was wondering if there were recommendations about if he should get the second dose of the product, considered his symptoms. Patient confirmed that he had no other vaccines on the same day as the COVID vaccine and other than his normal prescriptions, there are no new scripts that he started recently, it is only medications he has been taking for a while. No further details were provided by the Patient. Outcome of the event was not recovered.   Follow-up (18Feb2021): This is a Follow-up spontaneous report from a contactable Consumer. This consumer reported included weight, height and clinical information.   No follow-up attempts are possible. No further information is expected.
I did not have an adverse reaction to the vaccine. I started not feeling well on 02/14/2023 with a fever and body aches. I tested positive for COVID-19 on 02/14/2023.  I contacted my doctor and got a prescription for Paxlovid. I tolerated the medication without any complications. As of today, I do not have any lingering symptoms of COVID-19.
Shortly after receiving the vaccine#2, I began to notice my left ear 'filling up' like a swimmer's ear, and by April 22 at 8:30 in the evening, all hearing in the left ear was gone.  Thinking it was a wax build-up, I saw a PA at our clinic on April 26 at 4:10 pm, who removed a slight amount of wax. Two days later on April 28 at the ENT clinic, I had a hearing test which showed extremely low hearing levels, compared with a hearing test completed at the same ENT clinic on March 8 - (this was a general hearing test which was 'normal').  The ENT PA explained my condition was not due to wax but possibly a small blood clot or tumor preventing blood flow to the inner ear.  An MRI has been scheduled and Prednizone 60 mg prescribed.  As I began the Prednizone treatment April 28, I began to wonder if this might be an adverse effect of the Covid-19 vaccine.
This spontaneous report as received from a Licensed Practical Nurse (L.P.N.) refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 29-SEP-2015, the patients were vaccinated with improperly stored PROQUAD (Merck) injection (lot # L019994, expiry date: 02-DEC-2016, route and site of administration not reported) or VARIVAX (Merck) (captured in MARRS # 1510USA000576). No adverse events were experienced. The outcome of the reported events were unknown. No product quality complaint (PQC) was filed. This is one of two reports from the same reporter. Additional information has been requested.
Pt complained of pain the day after vaccination. That evening mom noticed area on L thigh red and swollen. On 3/12/04 was seen by Dr. Area on L thigh more red and swollen, advancing up inner thigh. Pt give 1 gm of Ceftriaxone and started on Keflex 250mg qid x 7d.
Extreme fussiness initially, then periodic episodes of tensing entire body for 10 second intervals multiple times over around 1 hour on evening after shots given. Seen in ER, temp there 99.6. Lab work normal. No further episodes. Sent home.
On 4/6/21 I received the JJ shot on 11/23/21 on 11/27 my left leg was hurting on 11/29 it hurt to walk on  on 11/31 leg use swollen large  my primary said go to the ER immediately there I found out I have a blood clot in my leg ( DVT )  I know all this is still in study so I needed to report this  There is no other reason of explanation of this occurrence  my doctor has been following this as well.    Thank you
Axillary and neck rashes; This is a spontaneous report from a contactable other hcp. A 25-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 03Feb2021 (age at vaccination 25years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Topical antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in 2 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced axillary and neck rashes on 05Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021. The patient received treatment for the adverse events with hydrocortisone. The clinical outcome of the event was re-covering. Therapeutic measures were taken as a result of axillary and neck rashes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mom reports that two days after administration, child developed severe diarrhea and exhibited signs of stomach discomfort. This continued for six or seven days. Mom did not take the temperature of the child because "she didn't feel warm to me".  Mom denies any seizure activity. Mom reported inconsolable crying for hours at a time with babe moving her legs like she had stomach cramps. Babe was not taken in to medical care. Mom reported this today to me. Babe has received a second dose of Rotavirus as ROTARIX, given by another clinic, and had a similar, but even stronger reaction to that dose.
Pain in site of injection (right shoulder) and some tingling in fingers with some tongue swelling. We offered the patient that we can call 911/paramedics or give her the EPI shot. Patient did not want to go to the ER or get the EPI shot. We gave the patient a one time oral dose of benadryl 50mg and observed the patient for one hour. Her condition did not worsen and she was able to communicate clearly and was breathing normal. Her mom came by to pick her up after the one hour. Then we gave her the liquid Benadryl to take home and advised her to take onther dose of 25mg in 4 hours. I followed up with the patient and she told me that her mom took her to the ER to fully get her check her out.
Patient stated that he had a fainting incident after receiving a flu-shot about 7 years ago. After carefully reviewing his current condition, both parties agreed to receive an MMR vaccine for his school purpose. Immediately after giving MMR vaccine, patient appeared to be slightly pale. Patient was advised to drink some water and remain seated next 10 minutes. About 10 minutes after receiving the vaccine, patient's face turned pale, and he lost consciousness for 2 seconds in sitting up position, holding up his both arms close to his chest. Patient gained his consciousness quickly after the incidence and laid on the bench with his legs elevated. After 10 minutes of lying down, his blood pressure was measured at 116/65 and pulse was 56. His face color returned to normal, and patient was able to make conversation. No sign of shortness of breath or allergic reaction. Second blood pressure was measured 10 minutes after, and it came back 121/70 with pulse 56. Patient and mother agreed to leave. Follow-up phone call was made at 6:30pm on the same day. Mother stated "He is fine and back to normal himself".
diaphoresis Narrative:  He reported increased feelings of anxiousness, dizziness, and flushing about 30 seconds after receiving the vaccination. He was brought into an examination room for further evaluation. Patient c/o increased feeling of warmth, headache at temples, diaphoresis, dizziness, and likened the feelings to what he normally gets during an episode of a panic attack. He denied swelling, pruritus, urticaria, flushing, disorientation, weakness, SOB/stridor, and nausea/abdominal cramping. He had eaten and hydrated prior to the appointment. Notes that he has felt ill with past vaccinations and typically avoids them. O: T 98.2F BP 123/75 HR 96 RR 12-15 SpO2 96% on RA Gen: non-toxic, initially appearing in mild distress - which quickly dissipated, answering questions appropriately, pleasant HEENT: atraumatic/normocephalic, PERRL, nares patent, no swelling Neck: no swelling CV: regular rate and rhythm, normal S1/S2, no murmurs Pulm: clear to auscultation bilaterally with no wheezes/rales/rhonci Ext: moves all 4 spontaneously, no edema, able to ambulate with single point cane Skin: no lesions or rashes, healed tattoos Neuro: CN II-XII grossly intact, 5/5 strength UE and LE Psych: appropriate, thoughts linear and non-tangential A/P: 45 yo patient here at vaccination clinic with stress/anxiety response to injection. Sx resolved w/in 3 minutes other than mild HA at temples. Response not concerning sx of immediate allergic reaction, angioedema, or anaphylaxis at this time. Patient was able to consume an entire bottle of water w/o difficulty during the interview, which also a/w resolution of the sx. Reaction to vaccination normalized and reassurance provided. Plan at this time: *Common adverse effects of vaccination reviewed and when to seek care *Specifically reviewed s/sx concerning for an immediate allergic reaction/anaphylaxis + 4 hour post-vaccination timeframe reviewed with ER precautions discussed *Advice for next vaccination also reviewed (eg eat/drink prior to appt, consider bringign a driver if feasible, try to have an easy/low stress day after the vaccination). Also offered that next vaccination can be administered laying down, which was politely declined
Arm swollen, red raised in the size of whole had beyond the shot, Pain in hips, back and all of joints and nausea and fatigued and was uncomfortable  due pain and fever 99-100  on and off. Head aches  really rough day  36 hours later 48 hrs or more in total.
I tested positive for COVID-19 06/21/2022. I had a scratchy throat first. Them, I felt like I had a cold. Then, when I went to the doctor I had a fever 100.6, and a headache. That is all the symptoms that I had. I was prescribed penicillin, which I did not take. I called and asked to be prescribed PAXLOVID and they refused to do so until my PCR test came back positive. It did come back and positive and I was prescribed PAXLOVID, but I didn't take it because by the time I got it, I felt better. I still have a little nasal congestion, but all the other symptoms are gone.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies (not specified) and asthma. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 at right arm for covid-19 prophylaxis. Age at time of vaccination 57 years old.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received second dose of non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin was not reported, batch number: 021C21A, expiry: unknown) dose and frequency were not reported, administered on 05-NOV-2021 at right arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 vaccine (Dose number in series 2). The patient received third dose of non-company suspect vaccine included: Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 3) (form of admin, route of admin was not reported, batch number: FP7150, expiry: unknown) dose and frequency were not reported, administered on 20-AUG-2022 at right arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Pfizer biontech covid-19 vaccine (Dose number in series 3). The patient received fourth dose of non-company suspect vaccine included: Moderna covid-19 vaccine (bivalent) (elasomeran) (Dose number in series 4) (form of admin, route of admin was not reported, batch number: 023H22A, expiry: unknown) dose and frequency were not reported, administered on 06-DEC-2022 at right arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 4). Concomitant medications included Astepro (azelastine hydrochloride), Allegra (fexofenadine hydrochloride) and Flonase (fluticasone propionate).  On an unspecified date in DEC-2022, the patient experienced suspected covid-19 infection (Dose number in series 4). The patient received non-company suspect drug Paxlovid (form of admin and route of admin was not reported, batch number and expiry date was not reported) dose and frequency were not reported administered from 13-DEC-2022 to 17-DEC-2022 for covid-19 treatment. On 23-DEC-2022, the patient was sick again (Dose number in series 4). The patient recovered from sick again on 01-JAN-2023.  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran, elasomeran was not applicable and for paxlovid was drug withdrawn. The patient recovered from suspected covid-19 infection on 01-JAN-2023, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Excruciating, debilitating pain in arm. Can?t lift or use arm.  Started around 7 hours after injection. Not the normal soreness or stiffness that I?m familiar with from other shots.
tired; arm was sore; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: ER8732) at the age of 38 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "unknown", described as "arm was sore". Additional information: The patient stated the day after receiving vaccine her whole arm was sore and she was tired.  No follow-up attempts are possible. No further information is expected.
The vial was initially stored in the refrigerator on 21-Jun2022 and administered on 27-Jul-2022; Administer a vaccine to a patient after the after 30 day use day; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a patient after the after 30 day use day) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Jun2022 and administered on 27-Jul-2022) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a patient after the after 30 day use day). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Jun2022 and administered on 27-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a patient after the after 30 day use day) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Jun2022 and administered on 27-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient did not experienced a similar event in the past. No concomitant product use was provided. Dose administered after 30-day Use by Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator on 21Jun2022. The AE does not cause patient to seek medical care. The vial did not undergo any temperature excursions. The symptoms have improved. No treatment medication was provided.
Injection site swelling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient is presenting with significant bruising on the left arm inferior to the injection site on the left deltoid.  Husband came in to notify us of it, I advised him to have it examined by her physician or urgent care/ER
Metallic taste to food; Body aches; Extremely tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:00 (Lot number: ER2613) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 24Mar2021 17:00, outcome "recovered" (25Mar2021 17:00), described as "Metallic taste to food"; PAIN (non-serious) with onset 24Mar2021 17:00, outcome "recovered" (2021), described as "Body aches"; FATIGUE (non-serious) with onset 24Mar2021 17:00, outcome "recovered" (2021), described as "Extremely tired". Therapeutic measures were not taken as a result of dysgeusia, pain, fatigue.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Screaming episode lasting 48 hrs p/last DPT 6MAY92;
I woke up with headache; pain in left arm; nauseous; all my major joints hurt; Could not eat all day; Then, my legs (from the knees down became cold even with 2 blankets).; Today, I still feel awful; Booster; This is a spontaneous report from a contactable Other HCP (patient). A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 301358A), via an unspecified route of administration in arm left on 08Oct2021 12:30 (at the age of 71 years old) as dose 3 (booster) single for covid-19 immunisation. Medical history included arthritis. Concomitant medications included ezetimibe (ZETIA). The patient previously took Statins, strawberries, Codeine, Sulfa and experienced allergy. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El9263) via an unspecified route of administration, administered in arm left on 30Jan2021 09:30 as dose 1, single for covid-19 immunisation and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19265) via an unspecified route of administration, administered in arm left on 20Feb2021 09:00 as dose 2, single for covid-19 immunisation, influenza vaccine (FLU) taken for immunisation from 27Sep2021 to an unspecified stop date. The patient was not pregnant at the time of vaccination. The patient receive Flu vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 08Oct2021 12:30, administered booster. On 09Oct2021 07:00, the patient reported that I woke up with headache, pain in left arm, nauseous, all my major joints hurt, could not eat all day, then, my legs (from the knees down became cold even with 2 blankets) and today, i still feel awful. The treatment of the event was unknown and not reported. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Rash on finger, toes that spread to hands, feet. Immediately very itchy then swelling worsened and heels were painful when standing. Came to clinic on day 3; diagnosed with erythema multiform. Treated with prednisone x 4 days; follow up next day to review lab which only showed mild ESR elevation and improvement of symptoms.
Fever of 102 did not subside for an entire week and tylenol was no longer effective after 2-3 days.  ER gave him advil, which helped.
blood clot was discovered in the left leg; excruciating pain in the left leg below the knee; area is swollen; Area of the left leg below the knee is red; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot was discovered in the left leg) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (blood clot was discovered in the left leg) (seriousness criterion medically significant), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red). At the time of the report, THROMBOSIS (blood clot was discovered in the left leg), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red) had not resolved.            The patient's concomitant medication was not reported. The information regarding the patient's treatment medication was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-116642 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.