chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My skin start infection rash.; My skin start infection rash, itching, stining, all over my neck, ear, face and arm,; My skin start infection rash, itching, stining, all over my neck, ear, face and arm,; My skin start infection rash, itching, stining, all over my neck, ear, face and arm,; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 10:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient's past drug history was reported as unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 13Mar2021 at 08:00, the patient experienced skin infection with rash, itching, stinging all over neck, ear, face, arm and was very painful. The event resulted in emergency room/department or urgent care. The clinical outcome of the events skin infection, rash, itching and stinging were not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
TOOK LAST DOSE ON DAY 6; This case (PVX2019-2208) was received from a nurse on 29-Aug-2019. It described an adult female consumer who "took last dose on day 6" (PT: Inappropriate schedule of product administration), while being on oral Vivotif capsule for typhoid prophylaxis.  Case report: The consumer took the last dose of Vivotif on day 6. The doses were taken on 23-Aug-2019, 25-Aug-2019, 27-Aug-2019, and 28-Aug-2019.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of reported events was unknown.  Company's Comment: The causality of the event "took last dose on day 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose on day 6" was considered as not applicable.
Fever fatigue, chills, sore arm Narrative: Low grade fever. Rested, hydrated only, no OTC meds taken.
Within 15 minutes of receiving my first dose of the Phizer vaccine a portion of my arm went numb as if I received Novocain from the Dentist. This only impacted the portion of my arm between my elbow and shoulder. My hand was not numb. My entire head also felt as if I was coming off Novacain. I would also get hot and cold flashes. My upper body was itchy. I also felt like I was having circulation issues (like if you sleep in a weird position). The tips of my fingers and toes would be cold. I believe the Novacain issue was attributable to the shot but some of my other issues might have been the result of a panic attack as a result of my face going numb. I went to the ER but by the time I saw the doctor around 12:00pm most of these symptoms were going away. I went to bed and woke up much better. I can feel my arm now. It just feels sore but what I expected it to feel like after the shot. The Novacain feeling in my head went away now I just have a mild headache. The key symptom I was concerned about was the Novacain feeling given my wife also received the shot and did not have this experience.
FLU AND PNEUMO in (R) arm, Wed NOC, redness, rash at injection site, weakness of legs, unsteady - Improved by Mon 10/6/08
About 18 hours after I received these two vaccines, I experienced lethargy, then about 1 hour after dinner, I experienced chills, shortly followed by explosive emesis and the diarrhea.  Diarrhea and lethargy continued for another 24 hours.  Diarrhea hasn't quite resolved at 30 hours from the start of  this, however, it has improved.
Information has been received from a pharmacy risk manager concerning a 60 year old female who on 15Nov03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed cellulitis at the injection site. The pt was hospitalized to received inpatient treatment with antibiotics. There was no product quality complaint involved. Additional information has been requested.
Received phone call from clients daughter.  She stated mothers right arm is red and swollen to the elbow.  warm to touch and painful to use it.  It look yellow under the skin where she was stuck.  She was advised to go to MD for evaluation.
Initial screaming with abdominal pain, not eating well, loose stools, fever, and fussy on days 2-4 post vaccine. Stools became bloody. Mom was breast and syringe feeding x >2 weeks. Stools and feeding eventually returned to normal.
Patient tolerated well no adverse reaction, dose was given after vial was in fridge past 30 days,
lt arm painful w/spasms;pale skin tone;lightheaded;T97.7;
Dose 1-04/11/2021,. Mild Swollen Tongue, sore left arm, mild body aches Dose 2-05/04/2021-Moderate Swollen Tongue, Moderate Left arm, moderate body aches, difficulty breathing, and mild headaches.
Pt recvd pneumococcal vax on 26FEB92 & on 27FEB92 devel a diffuse rash which started on chest & was described as maculopapular; It spread to arms, back & trunk; 28FEB92 seen @ clinic; 2MAR92 pt reported lesions had completely disappeared;
warning stroke; left side of face was tingling and prickly/left arm was weak and tingled; left side of face was tingling and prickly/left arm still is tingling, has prickly feeling; bad headache; left arm was twitching; left arm was weak; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 51-year-old non pregnant female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- EW0202) via an unspecified route of administration, administered in arm left on 01Jul2021 16:15 (age at vaccination 51 years) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported. The patient medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), bupropion hcl and amlodipine besylate. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0186) via an unspecified route of administration, administered in arm left on 07Jun2021 14:45 (age at vaccination 50 years) as dose 1, single for COVID-19 immunization. The patient previously took anaprox, Compazine [prochlorperazine maleate], flagyl [metronidazole], amoxicillin, prednisone and experienced allergy. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. It was reported that month after 2nd shot on 04Aug2021 13:15 left side of face was tingling and prickly also had a bad headache. Went to emergency room. Was diagnosed with a warning stroke on 04Aug2021 13:15. Month and half after second shot on Aug2021 while having Remicade infusion treatment left arm was twitching. After infusion, left arm was weak and tingled on 04Aug2021 13:15. Two weeks later infusion left arm still was tingling, has prickly feeling and twitches. Her husband who received his shots a month before her was experiencing tingling and twitching in his arm where he received his shot too. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness of the event warning stroke was medically significant and all other events were reported as non serious. The patient underwent lab tests and procedures which included Nasal swab: negative on 05Aug2021 and 10Sep2021. The patient did not receive any treatment for the adverse events. The outcome of all the events was not recovered.
Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches,  high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered.  Information on the lot/batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that, she gave the patient SHINGRIX vaccine subcutaneously approximately three weeks ago, which led to inappropriate route of vaccination. The patient experienced fevers two times which were resolved. The reporter was unwilling to provide any additional details and was transferred to Medical Information.
Pain in R arm, redness, hot to touch, fever, chills, no appetite, weakness, headache.  Pt put on antibiotics on 3/16/16.
Administered a second dose of the Moderna Covid 19 vaccine from a vial that had been first punctured 22 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a second dose of the Moderna Covid 19 vaccine from a vial that had been first punctured 22 hours ago) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A and 022J21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had twice before receiving the first dose).   On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2022 at 7:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 7:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a second dose of the Moderna Covid 19 vaccine from a vial that had been first punctured 22 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a second dose of the Moderna Covid 19 vaccine from a vial that had been first punctured 22 hours ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Twice before receiving the first dose.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had not reported any symptom after receiving the vaccine.  The patient did not take concomitant medication. The vial was initially stored in the refrigerator was on 21 Feb 2022 and punctured on 21 Feb 2022  at 9.00 AM. The vial was exposed to room temperature range for 3 minutes.No temperature excursions reported. No treatment medications reported.
Right Arm started showing a rash and heat about an hour after the injection of the Fluad injection. The rash has continued to today 10/14/2022 and the injection was given on 10/12/2022 the same day that the injection occurred.
Redness and swelling at the injection site. Large lump or knot under injection site.
felt something itchy,; there was a round site and it was pinkish,; swollen but very very little,; sores the same thing as if got a flu shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (felt something itchy,), INJECTION SITE ERYTHEMA (there was a round site and it was pinkish,), INJECTION SITE SWELLING (swollen but very very little,) and INJECTION SITE PAIN (sores the same thing as if got a flu shot) 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 13-Jan-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 INJECTION SITE PRURITUS (felt something itchy,), INJECTION SITE ERYTHEMA (there was a round site and it was pinkish,), INJECTION SITE SWELLING (swollen but very very little,) and INJECTION SITE PAIN (sores the same thing as if got a flu shot). At the time of the report, INJECTION SITE PRURITUS (felt something itchy,), INJECTION SITE ERYTHEMA (there was a round site and it was pinkish,), INJECTION SITE SWELLING (swollen but very very little,) and INJECTION SITE PAIN (sores the same thing as if got a flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Extreme abdominal pain. Went to ER on Friday April 2nd 9:00 PM.
Patient did not receive the vaccine at our hospital, but reporting since she presented to the ED.  Patient presents to ER. Reports is a student teacher through  school  and received Moderna COVID19 vaccine yesterday. States that she started having high heart rate today, between 120-160. On presentation, patient's heart rate was elevated, measuring from 110-160 in the ER. Patient also had 103F oral temperature. Patient denies taking any other medication. Patient ultimately had to have labwork and imaging done.   Will give  tylenol for fever and  NS bolus.  Labs imaging to include CBC, CMP, Mg, lactic acid, TSH/Free T4, UA, urine preg, CXR, and EKG.  EKG with sinus tachycardia and S1Q3T3 pattern.  CXR without evidence of acute cardiopulmonary process.  D dimer 640.  Mg 1.6, Na 133, K 3.4.  TSH/T4 unremarkable.  UA with trace leukocyte esterase.   Given EKG findings and elevated d-dimer, will obtain CT w contrast to rule out PE.  CT does not show evidence of acute PE.  Patient is afebrile and stable for discharge.  Discussed with patient that symptoms are likely due to inflammatory reaction following the COVID vaccine.  Recommend symptomatic treatment at home and activity as tolerated.
Patient had a hot, red spot on her arm where the vaccine was given. The spot was about 2 inches long and 1 inch wide and then the patient stated that it doubled in a matter of hours so she was advised to see her doctor. The doctor thought it was cellulitis and prescribed cephalexin and MEDROL DOSE PAK.
diagnosis given is Bell's Palsy; This is a spontaneous report from a contactable consumer.  A non-pregnant 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 02Sep2021 12:00 (Batch/Lot Number: FC3182) as dose 1, single (at the age of 34 years old) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medication included estradiol and meloxicam, both taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and codine linctus and experienced known allergies.  On 14Sep2021, 12 days after first shot, the patient experienced facial numbness/paralysis on one side of my face. On 20Sep2021 following an emergency room visit the diagnosis given is Bell's Palsy. The patient was given prednisolone. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Pt recvd vax 16OCT92 & w/in 6 hr of vax pt devel arthralgia in both shoulders, both elbows & both wrists; pt recovered;
rapid heart beat; This is a spontaneous report from a contactable consumer, the patient. A 74-year old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the right arm on 27Jan2021 at 00:30  (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included asthma; allergies to sulfur drugs, papaya and mango. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included metformin, salbutamol sulfate (PROAIR), ergocalciferol (VIT D), montelukast, losartan. There were no other vaccines within 4 weeks of the vaccination. On an unspecified date in 2021, after the first vaccination, the patient experienced rapid heartbeat for four days. The patient was not treated for the event. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of rapid heartbeat was resolving.
Received booster dose of AVA 18 Aug in rt arm. He premedicated 30 min prior with ADVIL 600 mg and BENADRYL 50 mg. He took one dose of ADVIL 600 mg post booster. He returned to clinic 20 Aug with arm swelling and erythema localized to upper arm. Also developed the recurrence of "Hives" on left upper arm. Pictures provided. Symptoms: Erythema, Lesions, wheal, Edema @ injection site 30-50mm.
20OCT Encephalopathic w/progressively inc lethargy, gait unsteadiness, dysphagia & anorexia; low grade fever x 1 wk;
Severe chills, fever, joint aches, head aches, coughing and loss of taste.   Given the severity of the side effects as well as the coughing and loss of taste a COVID-19 rapid test was conducted on Sunday 17 October. Test was negative, which may confirm that all these side effects are related to the 3rd dose.
fatigue; chest congestion; chills; altered smell; This is a spontaneous report from a contactable health professional reporting for herself.   A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot#EJ1686 via intramuscular route at the left arm on 20Jan2021 01:00 PM at single dose for COVID-19 immunization. Medical history included Hypothyroidism and allergy to codeine and sulfa. Concomitant medications were not reported. The patient had received the first dose of the same vaccine on 30Dec2020 01:00 PM from lot#EL1284, via intramuscular route at the left arm. On unknown date the patient experienced fatigue, chest congestion, chills and altered smell. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events. Prior to vaccination, the patient was diagnosed with COVID-19 on unknown date. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 26Jan2021 and the result was negative. The outcome of the events was not recovered.
Early morning on 10/19/2021 the patient presented elevated temperature.  Early morning on 10/20/2021 the patient presented eruption son the left side of the face, neck and under the armpit.  Present pain behind the face.
2 DAYS AFTER VAX, EXP ITCHY RASH ON FLEXOR SURFACES OF ARMS OF ANTECUBITAL SPACES. TREATED /W/ CYCLOCORT CREAM, TOPICALLY. REPORTING PHYS DOES NOT THINK THIS WAS A REACTION TO VACCINE.
First pain/soreness in back (between shoulder blades) and a stiff neck. Then about 48 hours later multiple recurring seizures (petit mal) - almost hourly for 3 days until seizure medication (Depakote) taken.        I had not had seizures for years and had stopped taking my seizure meds earlier this year.  I had had flu shots before (while taking the seizure meds) without problems.  I still have the still back & neck but seizures are subsiding (now that I resumed my meds).
10 days after dose had an Itchy arm, followed the next day with a circular red rash and pain. Pain subsided later in the day but rash spread every day to cover upper arm and no longer circular.  I looked on line  and saw it is ?moderna arm?.   Went to the local pharmacy when it didn?t go away after five days and the pharmacist confirmed it was a localized allergic reaction and not to worry. It started to fade and was gone after 6 days.  Never took Benadryl. She said Benadryl will help so I have some in case it happens again after the second shot I had today. A nurse at the second dose site said to file a report with you.
Pt vaccinated with DTP developed fever, vomiting, lethargy, and bulging fontanelle. Observed closely. No antibiotics given. Bulging fontanelle subsided within hrs after LP. Fever persisted 5 days. Poor appetite for 5-6 days. Full recovery.
I received the vaccine at 12:15 PM.  I was a little tired but generally fine the rest of the day. I woke up at 2:30 and didn?t feel well. I got up to go to the bathroom. I started getting the chills and feeling dizzy. I passed out. My wife found me  passed out on the ground and bleeding. I needed six stitches in my head and have a black eye as well as other facial lacerations. I have no recollection of anything until my wife woke me.  I have never passed out in my life prior to this.
Fever of 102.2-102.6 for4 days, flushed, weak.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 09:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM 2- HTN" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing), notes: Known allergies: Shrimp; "DM 2- HTN" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective / COVID-19 cannot be ruled out