chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An inmate received a third dose of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (An inmate received a third dose of the Moderna COVID-19 Vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A, 025J20-2A and 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM (KEPPRA XR), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), ZONISAMIDE, IBUPROFEN and OXCARBAZEPINE (TRILEPTAL) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (An inmate received a third dose of the Moderna COVID-19 Vaccine). On 28-Apr-2021, EXTRA DOSE ADMINISTERED (An inmate received a third dose of the Moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Rapid onset sore neck and shoulder on left side (same as injection side). Lasted for 5 hours.  Took Tylenol.
got like a rash developing on front torso; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: EN6201, Expiration Date not reported) via an unspecified route of administration, administered in the left arm, on 23Feb2021 (at the age of 59-years-old), as dose 2, single for COVID-19 immunisation. The patient has no relevant medical history and no concomitant medications. The patient got like a rash developing on front torso on an unspecified date in Feb2021. Patient was wondering if it was a typical reaction or if it was from the Pfizer vaccine possibly. Patient did not receive any treatment. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
On 11/17/2022, sore throat. Sore throat continued, cough without production, fever, the highest 101 once, continued like that for a week or 5 days. On 11/17/2022 I took a COVID-19 home test and the result was positive. I called the doctor on 11/18/2022, I had a phone consultation with him, and he gave me 3 prescriptions. Zinc 220 tablet, prednisone 10 mg tablet, and azithromycin 500 mg tablet. It took the full 10 days for me to feel better. A little bit of a body ache, dry cough, achy. On the 11 or 12th day I was coming out of it 100 percent.
On 5/4/21 I started to get a rash / hives on my feet and ankles.   The next day it was worse and I discovered I had a rash /  hives over most of my body.   So I started taking some Benadryl on 5/5/21 to see if that would help.   But on 5/6 the rash / hives were worse.  I did not have a fever, shortness of breath or any other adverse reactions.   I made an appointment with my Doctor on 5/7/21 at 9AM.  She said I was having an allergic reaction to something,  but not sure what.   She prescribed a series of Prednisone over a 7 day period.   After getting home I found several articles about delayed skin reactions to the Pfizer Covid vaccine,  so I thought this could be the issue.   I have never had this kind of reaction before and nothing had changed in my daily routine,  foods or drink.  Today,  5/11/21,  the hives / welts have subsided,  but the rash still remains.
I had a routine mammogram on 2/5 and my left breast (shot was given on left side)  was abnormal. I was sent for an ultrasound on 2/10. They found multiple cysts in the left breast and believe the suspicious area is a cyst but I have to return in 6 months for a follow up. My left breast is slightly sore, especially when I lift my arm.  Also, not sure if it?s related but it is worth reporting that my PMS was extreme 2/21 (extreme exhaustion and cramping).  After my u/s I received a text from v-safe asking if I had any new symptoms and they called me and recommended I fill out this report.
I felt a little flushed; My heart is breathing; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 21Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated: I felt a little flushed and my heart is breathing on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Bitemporal frontal throbbing headache, 10/10 intensity, lasting 3-5 minutes, reoccurring every 30 min over the past 6 days, unrelieved by advil. No other associated symptoms.
Clients mother called on 9/29/04 stated upper area had large knot and client c/o pain in arm. Client has CP advised result <PCP.
This spontaneous report was received from a Nurse and refers to improperly stored products which had not been administered. On unknown dates, vaccines of PROQUAD (which had a lot # L031602, expiry date on 18-FEB-2017, exact doses and route of administration were not reported), were improperly stored as the freezer was out of range on and off since 06-JUN-2016. Other doses of PROQUAD which had a lot # L040415 with expiration date on 13-APR-2017; Lot # L021601 expiration date on 10-DEC-2016. Nevertheless, no symptoms were reported. The vaccines experienced the following temperature excursions during 48 hours (2 days): 10 grades Fahrenheit. Reportedly, there were previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
This spontaneous report was received a certified medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ROTATEQ oral which had been previously exposed to 33.6F for 1 hour. No adverse effects reported. Additional information is not expected due to the reporter did not want to be contacted again.
The patient arrived to the clinic to receive a Moderna Booster. The Moderna Booster is a dose of 0.25 mL, but the vaccination was charted as 0.5 mL given. There is no way to know if the correct dose was given, as it was charted as a 0.5 mL dose. The patient did not have any abnormal reaction while waiting for their 15 minutes wait time in the clinic lobby.
Pt reported arm pain at injection site starting ~ 1 hour after receipt, also general fatigue.  Pt had dental appointment day after vaccine administration and reported needing more novocaine than typical.
Covid symptoms. Fever of 102 for 3 days. Cough ( still occuring) sweating. Generally feeling unwell as well as runny nose. Headache. Pressure around eyes. Sensitive to bright light.
Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain
I developed Covid symptoms of June 24, 2022 (fever, runny nose, sore throat, fatigue). I took a rapid Covid test that day and it was positive.  I consulted my physician, who prescribed Paxlovid. I immediately began a five-day course of Paxlovid medication.  My symptoms subsided in about 2 days.  On June 30, a rapid Covid test was still negative and I was feeling much better.  On July 2, about 3 days after completing the Paxlovid regimen, I developed a runny nose and sore throat, but no fever.  I took another rapid Covid test and there was a faint test line indicating I was positive again. My symptoms were mild and a few days later I took another Covid test that was negative.  I feel fine now.
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, route, lot# and expiration date were not reported). Concomitant drug was not reported. On an unknown date the patient experienced a localized infection at the injection site or an infection rash going up through the arm. The patient sought medical attention with the pharmacist, who then referred her to an unspecified physician. The physicians prescribed unspecified antibiotic therapies. On an unknown date, the patient was recovered after the antibiotic therapies were complete. The causality was not reported. This is one of the two reports from the same reporter. Additional information has been requested.
Fever (hot, no temperature taken). Arm achy, arm is itching. Circular, red, swelling around injection site. Signs/symptoms have escalated since date of injection 09/29/2014. No treatment - except aspirin 325 not scheduled dosing.
Rash consistant with drug eruption rash post 1st & 2nd dose of Hep B with 24-48 hrs of administration.
Severe shoulder, upper arm, pelvic and upper leg muscle and joint pain and stiffness.  Inability to raise arms and difficulty walking.  Pain  and stiffness first noted on Oct.  20th.  Pain and stiffness intensity has fluctuated since initiation of prednisone treatment on Nov. 7th. But it is consistently worse between 4 am and 12 noon. Polymyalgia rheumatica dx 11-07-23 by Dr.   Covid booster was NOT give in the central deltoid, but on the outer upper aspect of the deltoid. Lesion remained for 3 weeks at injection site. Had hi-dose annual flu shot at Dr.'s office, allergist, on Oct. 2, 2023
patient developed a rash 5 days after vaccine admin, dr dx as non spongiotic dermatitis
Took oral typhoid, #1 03/05/05 #2 03/10/05 #3 03/12/05, at 7 a.m. By 03/13/05, in the afternoon noticed eye looked swollen. By 03/14/05 both eyes were swollen and he had developed a rash on his abdomen. He took 2 25mg Benadryl at that time. On 03/15/05, he saw his physician who assessed an allergic reaction to Vivotif. Rash and swollen eyes have resolved.
02/05/22 presents to ED for "Left foot pain and dark discoloration". PMHx of "CAD, DM type II, HTN, HLD, and SBO s/p resection"
Relapse of Covid on day 9 after testing negative for several days. Mild symptoms, positive antigen test result.; Relapse of Covid on day 9 after testing negative for several days. Mild symptoms, positive antigen test result.; A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "migraine" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: PREDNISONE, start date: May2022, stop date: May2022, taken in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022 at 07:00, outcome "recovering" and all described as "Relapse of Covid on day 9 after testing negative for several days. Mild symptoms, positive antigen test result.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive, notes: Relapse of Covid on day 9 after testing negative for several days. Mild symptoms, positive antigen test result; (2022) Negative, notes: negative for several days. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 24May2022 to 28May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tonic-clonic seizures, 3 hours after vaccinations 7/10/09.  7/22/09 MR received for DOS 7/9-13/2009 with D/C DX:  Seizure Disorder. Pt presented several hours after 2 month shots with multiple recurring tonic-clonic seizures  with associated apnea.  O2 sats as low as 17%.  Improved with phenobarb.
After both vaccines, within a couple of days, I started having headaches/migraines that would not go away.  Dr. put me on steroids after both vaccines to help.  Prior to this time, they had been under control with preventative treatment, only having migraine 1x month, at most.  Since the vaccine, I have almost daily headaches and migraines still.  Also, have noticed depression where I do not want to leave the house or care about things in life.
Patient reported sudden onset of chest pain while was waiting in observation room.  He has no major medical problem, HTN or DM. No prescribed medications were taken this morning.  No dizziness, SOB reported.  per patient he had  headache, fever, body ache, and other flu like symptoms after taking the first dose, but no signs of allergic reactions. Vital signs: BP 150/100, HR 74, O2sat 98% on RA, Pain 5/10  consistent burning/sharp on left chest anterior.  Called 911 , ECG was done and result normal sinus rhythm. Patient was instructed to follow up with his primary  health care provider for further evaluation.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 09:00 as dose 1, single (Lot number: EL1283), in left arm, on 06Feb2021 at 10:00 as dose 2, single (Lot number: EL9264), in left arm, on 04Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 19Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 at 20:00 as dose 5 (booster), single (Lot number: AS7148B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Known allergies: NSAIDs" (unspecified if ongoing), notes: Known allergies: NSAIDs; "Known allergies: dye" (unspecified if ongoing), notes: Known allergies: dye. Concomitant medication(s) included: SERTRALINE, start date: 03Dec2018, stop date: 21Oct2022; AMLODIPINE, start date: 01Jan2019, stop date: 21Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, an association between the reported events and bnt162b2 cannot be ruled out.  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.
Vitals:  11/08/21 1037 11/08/21 1042 BP: (!) 155/90 125/81 Pulse: 67 66 Resp: 18 15 SpO2: 100% 100%  Vital signs at 1058 BP 122/80, HR at 66, sat 99% in room air  1037 Patient c/o numbness and tingling in the lips and right fingertips. Taken to gurney. Checked vital signs. Please see vital signs. Denies pain, denies SOB, no redness, no swelling in lips, tongue or throat. No rash noted. Speaks in full sentences. No audible wheezing noted.  Patient states the same thing happen on his first dose, benadryl helped per patient.  1040 bendaryl given 25mg ORAL x1  1042 patient states the numbness in the lips is going away, but numbness to fingers still present Vital signs remain stable at this time 1053 remains stable.  Denies pain, denies SOB, no redness, no swelling in lips, tongue or throat. Speaks in full sentences. No audible wheezing noted.  11:00 patient states he is having chest pain. 1/10. New onset, never happened before per patient. Vital signs stable. 130/76, 64HR 100% in roomair. Afebrile. Placed in 2LNC Paramedics called  Taken via gurney to ER for further eval
Approximately 20 minutes after vaccination,  patient reported feeling like her throat was swollen.  She was alert and complained of no other symptoms. Breathing was normal. Advised patient to extend 15 minute post vaccination wait to monitor for worsening of side effects. Patient reported feeling the same. Gave patient benadryl and continued to monitor patient. After taking benadryl, she stated that her symptoms were improved.
According to the Occupational Health Nurse, patient received the flu vaccine on 11-2-06, on 11-3-06 began complaining of itching and a rash generally over body. He went to a doctor and received medication for symptoms and has made a full recovery back to his pre-vaccine state.
Medication leaked down my arm; the needle hub wasn't screwed on all the way; A spontaneous report  was received from a dentist concerning a 29-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication leaked down my arm/ Vaccine under dose and the needle hub wasn't screwed on all the way/ syringe connection issue.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 2 Feb 2021, approximately same day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration in the unknown site for prophylaxis of COVID-19 infection.   On 2 Feb 2021, prior to receiving mRNA-1273, the patient experienced medication leaked down my arm and the needle hub wasn't screwed on all the way. Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events, medication leaked down my arm and the needle hub wasn't screwed on all the way were considered resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered and  Device connection issue for mRNA-1273, lot # unknown  with no associated Adverse Events.
After my second dose of moderna my injection site bled down my arm. The person administering the injection cleaned the wound. I had pain in my shoulder for several months from that moment until September. I also had a very irregular menstrual cycle during that same time frame with longer and more frequent cycles.
Starting 6 hours after shot, left arm soreness hurting. Patient used ice packs but no relief. She has seen her MD about 2 weeks after the shot (has not resolved). Dr. prescribed ALEVE (which patient is taking).
when I'm sleeping I feel a dry throat , I can't breathe my feet were very hot and the covid symptoms I have a strange feeling on my tongue
Nausea, lightheadedness, Skin-crawling feeling, Headache,  Symptoms began after eating a meal, around 7:30 PM and continued until about 2:00 AM.  Symptoms minorly alleviated with weighted blanket, rest, and tylenol.
Had swelling at site and lips swelled up from first dose symmetrically  but did not affect airway, had chills , and malaise , 2nd dose had more chills fatigue  , GI upset , nausea , swelling  at site of injection , arm pain  couple of small hives on arm no lip swelling with second dose  and migranous headache . Was not as bad as prior reactions to flu vaccine but enough to not feel well enough to go in to work Monday . Was able to go to work Tues though after Sat appt .
Within 24 hr of vax, pt complained of chills,flu-like sx & local area of redness 25x10 cm. It was reported that the patient recovered from the experience.
When I cough, I am coughing blood; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: FA7485 and Expiration date were not provided), via an unspecified route of administration, on unknown date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced when I cough, I am coughing blood. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Given the vaccination at 12:30pm on Sat. 5/22/2021 and on Sunday 5/23/2021 at 8:00 am, patient started having chest pain, shortness of breath, and severe right-sided headache. On 5/25/2021 patient had a loss of consciousness and is being evaluated in the Emergency Department
Systemic: Dizziness / Lightheadness-Medium, Additional Details: During the 15 minute monitoring period patient complained of dizziness and lightheadedness. Sat on floor, gave pt bottle of water and instructed her to lower her head. She never lost consciousness. She called her father to pick her up as she refused any suggestion of 911. By the time her family member arrived she was feeling much better. I walked her out to the parking lot and spoke to her ride. I called her at   7:10pm and she had slept/napped and felt back to normal.
Patient found lying on floor. Difficult breathing, tightness of chess. Patient "fainted" recovered. Displayed signs and symptoms of shock.
3/6 3:30pm received vaccine.  6pm felt foggy, extreme exhaustion, irritable, nauseated, arm pain.  Headache  3/7 12:30am restless in bed with muscle pain in thighs with burning sensation down into calves and up into lower back.  4:30am fever of 102 degrees Fever all day till about 8pm when temperature dropped below 100 degrees.  Chills throughout day Extreme fatigue throughout day Headache  3/8  No fever in AM 8pm felt queasy & nauseated continued overnight.  Extreme fatigue continued Slight cough  Headache  3/9 Temperature over 100  Chills Queasiness and nausea continued throughout remainder of day.  6:30pm lesser sense of taste Headache
the patient experienced Panuveitis flare up; the patient experienced Panuveitis flare up; blurred vision; inflammation; This is a solicited report from a non-Pfizer sponsored program received from a contactable consumer (patient), based on information received by Pfizer from Manufacturer Control Number: 21K-163-3939945-00).  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose; dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date  and ongoing, at citrate free (as reported) for non-infectious intermediate, posterior and panuveitis.  The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced panuveitis flare up, blurred vision, inflammation. The reporter's causality for the event of Panuveitis flare up with Humira (adalimumab) was a reasonable possibility. The action taken in response to the events for adalimumab was dose not changed. The outcome of the events was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Reported events are likely intercurrent and unrelated to BNT162B2.
Client has reddened arm, swollen and warm to touch.  Injections given 2 days ago 11/26/07.  She phoned physician and was told to continue ibuprofen and ice packs to arm.  Left arm.
ACUTE STROKE DUE TO ISCHEMIA (HCC)  NUMBNESS TO RIGHT SIDE OF FACE, CHEST, ARM, HAND, ABDOMEN, THIGH, LEG, FOOT, TOES