chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion). On 01-Sep-2021, PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that the vaccine was administered intramuscularly in the upper deltoid and the patients did not experience any adverse reactions following administration. The reporter stated that the vial was moved from freezer to fridge on 31Aug2021, and was only in fridge for a day prior to administration.  No concomitant medication details were provided. No treatment medication details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-SEP-2021 contains non significant information. On 01-Oct-2021: Additional information received on 04-OCT-2021: Vaccination anatomical site  added and Patient demographics added.
brain fog, dizziness, blurry vision, tinnitus, chest pain, chest oppressions, palpitation, tachycardia worst at night while resting will go up to 150hbpm, orthostatic intolerance specially getting out from bed. Fatigue: can't run in the morning anymore, walking one flight of stairs will wore me out. numbness and tingling in hands and feet. pain in hands and feet like pins and needles. hands and feet turning red and very hot. Pain in calves, extremely cold feet. weak legs. mayor constipation. Symptoms started in mid February sometimes improves but the orthostatic intolerance and tachycardia are getting worst, will have a Holter test schedule in September.
Confusion, trouble speaking, blistered up on the left foot, skin fell over, left foot amputated.
Nausea lasted 6hours. Dizziness 6hours. Fatigue 6hours. I didn't feel the lymph node until the 04/27/2021.
patient developed joint pain on the arm where the vaccine was administered. the shoulder joint pain is not constant but felt every  now and then. patient will have it checked by the c0ctor
Fatigue, Joint Pain, Feverish - Chilled, Hot; Nausea, Headache
She got her vaccine, she had a little soreness to be expected.  She woke up at 5:00 AM feeling sick.  Went to the other end of the house to use the restroom and everything was turning black, had a whooshing sound in her ears and had to lie down.  her husband got the BP cuff for her and it said low.  She drank Gatorade and ate some Saltines and rested for a while.  Then when she took it again it was 103/75.  She just ate high sodium foods that day and took it easy.  She just felt sick.  Her arm is still red, a little bit tender and swollen.    This also happened to her the first time she got her vaccine.   She had her first Shingrix vaccine on 7/20/22, which they told her to get the 2nd vaccine anyway.  She did not call them this time for this reaction.
A report was received from a healthcare professional on 10/16/2002, concerning a 14 month old female vaccine who was inadvertently administered 0.25ml intramuscularly in the vastus lateralis on the 15 October 2002. On 10/15/2002, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis.  The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: administered vaccine at 1:17pm, after a few minutes, CC of dizziness, feeling light headed and began to sweat. Pt sat with feet elevated and applied cold compress, BP was 106/69 with pulse of 71. pt remained seated for approx 20min and felt better, was able to get up from seat and walk out. did not seek any medical advise.
Soreness at area of injection, 102.2F fever, aches all over, weakness, tired, not hungry. Mostly occurred on 8/17. Some residual including low grade fever on 8/18 and 8/19. Seems to be recovering.
Patient received first Moderna vaccine. While in observation period, patient stated she felt like she had "cotton" in her throat and her face was tingling. VS were taken. She was laying on the litter. Patient kept stating she was not able to breath. She stated she had anaphylactic reaction prior but does not carry an Epi pen as it is to other medications. Patient asked to take her mask off and lay on her side as her breathing felt worse. Code was called. Patient was administered Epi pen. She was taken via litter to ED for assessment. Patient monitored in ED and discharged.
chest tightness; Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness) and DIZZINESS (Feeling dizzy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness) and DIZZINESS (Feeling dizzy). At the time of the report, CHEST DISCOMFORT (chest tightness) and DIZZINESS (Feeling dizzy) outcome was unknown. Not Provided
stomachache; fatigue; low grade fever; This is a spontaneous report from a contactable pharmacist. A 14-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced stomachache, fatigue and low grade fever. On an unspecified date, the patient underwent lab test and procedure which included body temperature measurement which showed low grade fever. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Negative; positive; Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Course: Received call from consumer who bought product from Pfizer Paxlovid for the COVID-19 virus. He got phone call from Pfizer and said Reference # He took Paxlovid for 5 days. Somebody called him back. He clarified that he had just left a message for medical information and had not completed a safety report before. He then stated his wife tested positive and took the pills also. Separate report completed for her. In Feb (year not provided), they got COVID-19 shots. They got Pfizer 2 shots and the booster and then everything was ok and then his wife went to away and they were tested when they get out of the plane and ship. She came back and got tested in withheld and came back to withheld. 4-5 days after that she felt funny and went to the drug store and bought a home testing kit. Hers was positive and his was negative. They don't know how she got it. He was surprised because they got the 2 shots and the booster. She wore the mask. He then asked what is the use of taking the shots. She took the 5 pills and wants to know what was the next step. He took them because he did not want to take any chances and thought it will not hurt him to take the Paxlovid. On his, it tested negative and the next day positive and the next day negative. He did not know what to make of it. He was an old man and doesn't have time to talk. He did not wish to complete report on himself or his wife and requested to be transferred to have his questions answered. No further details provided. The event of disconnection. Description of complaint: Took 2 Pfizer COVID vaccines and the booster and tested positive for COVID virus. On his, it tested negative and the next day positive and the next day negative. He did not know what to make of it. He did not wish to complete report. No further details provided. Product strength and count size dispensed: not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient appeared, pale, yellow, fatigued, hematoma noted in both thighs. Monitored patient for min. Baby was alert and feeding vigorously. Patient was discharged home.
Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 2 of the five patients who experienced local reactions. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced local reactions. The outcome of local reactions was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Two days after(Thursday) receiving the shot I felt cold-like symptoms.  On the third day (Friday) I had a massive headache and stuffy nose throughout most of the day. In the days that followed (Saturday, Sunday, and Monday) I had a massive headache with nausea and threw up at least twice on Saturday these symptoms lasted all three days. All three days I have had dizzy spells. Monday evening I started feeling better. The headache had gone away but I still had light dizziness. Tuesday (today) I woke up around 7:30 am to my left arm very sore and the injection spot where I got vaccinated swelled up again as though I had just gotten it. The spot feel warm and slightly sore.
Sudden onset mental cloudiness/fog on 4/10/2021..  I went to make  a bank deposit, but while in the car I could not figure out what I was to do in order to get out of the car.  I was aware something was wrong but I could not react nor answer because of the confusion and concern at the same time.  No numbness/weakness/tingling sensation of the face/arms/legs/tongue.  No headache/no visual complaints were associated. My husband, who had driven the car, stated I had a "blank" look on my face.  He kept saying are you OK several times.  The episode lasted less than 1 minute.  No further episodes since then.  No prior H/O mental fogginess except prior to my liver transplant in 2011. No prior H/O TIA/CVA.  I have been well since then.
28nov89 pt vax hepta B. pt ex pain at inject site.  28dec89 pt vax 2nd hepta B . pt ex prolonged pain and tenderness at inject site which lasted 2 days to 1 week. pt recovered.
Approximately a dime size circular area around injection site with tiny raised bump. Hoarseness for 2-3 days (no redness or edema noted, no shortness of breath).
Loss of pregnancy. Due date 02/10/2022. Date of loss 12/09/2021 at 31 weeks pregnant. I have a history of 4 healthy full term pregnancies prior to this. No complications in any pregnancies. This recent pregnancy 1 month post my first dose of the Moderna vaccine I developed tachycardia 12/07/2021. I called my OB 12/08/2021 to report the tachycardia and be seen. 12/09/2021 I went to OB for visit and was informed my daughters heart had stopped beating. My doctor assumed it had been within a day that her heart had stopped because she was measuring accurate to her due date.
mild symptoms of COVID toes after first vaccine, but much worse and still enduring after second vaccine.  Blue toes, tender toes, sx of pain, swelling and pins and needles consistent with peripheral neuropathy.
Breakthrough case admission after three vaccines Moderna 2/25/21 Lot# 023M20A;  Moderna 3/25/21 Lot# 007B21A;  Moderna 4/7/21 Lot# 027L21A
"I am" 8 days from my shot 1 Pfizer and "I" woke up with a really itchy red spot on right arm and soreness prior to today "I" did not have any reactions; "I am" 8 days from my shot 1 Pfizer and "I" woke up with a really itchy red spot on right arm and soreness prior to today "I" did not have any reactions; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Feb2021 at 16:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MOTRIN) and paracetamol (TYLENOL) from an unknown date for an unknown indication and unknown if ongoing. On 07Mar2021 (reported as one day prior to the date of report), the patient had soreness in right arm. On 08Mar2021 at 03:00, 08 days after vaccination, the patient experienced itchy red spot on right arm. The patient did not have any reactions before. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy red spot on right arm and soreness in right arm was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
MCV given in left deltoid at approximately 11:30 am.  Client left with no complaint after shot & went to restaurant.  Mom then states child complained of difficulty breathing & was taken to the hospital by EMS.
2 weeks ago the customer tested positive for COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (2 weeks ago the customer tested positive for COVID) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (2 weeks ago the customer tested positive for COVID). At the time of the report, COVID-19 (2 weeks ago the customer tested positive for COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive 2 weeks ago the customer tested positive for COVID, and a Few days later tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up contains non significant information. The reporter information was updated.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had one temperature excursion of 1008 hours and the lowest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
bacterial meningitis; Flu; caught strep; Initial information received on 29-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient who experienced bacterial meningitis, flu and caught strep after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor The patient's medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported (route, administration site, strength, formulation, expiry date and dose: unknown) for prophylactic vaccination.  On an unknown date the patient developed a serious bacterial meningitis (meningitis bacterial) and non-serious flu (influenza), caught strep (streptococcal infection) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available.   Action taken: not applicable  It was not reported if the patient received a corrective treatment for the events (bacterial meningitis, Flu, caught strep).  Outcome was Unknown for all the events  Seriousness criteria: Medically significant for bacterial meningitis; Sender's Comments: Sanofi Company Comment dated 02-Jan-2023: This case involves an unknown age and unknown gender patient who experienced bacterial meningitis, flu and caught strep after receiving influenza vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Pt started crying 5 minutes after receiving 1st dose of Pfizer. Parents were present, volunteer at site  was translating but patient wouldn?t say anything as to what is going on with her. 4 ice packs were used and water was offered. Blood pressure at 2:24pm 142/82 mm/Hg. Mom fainted to the floor from her chair seeing her daughter. Asked to call 911. Patient still crying and now mentions she is hurting all over. Mom gains consciousness and was sat back in her chair. EMT arrived at the site. Mom faints again and gains consciousness. Mom threw up. Patient was transported to near by hospital. Mom refused to go with EMT to the hospital.
pt recv vax & 3wk post vax pt exp varicella-like lesions on scalp, face & arms;pt recovered from exp;
Covid RAT positive on 09Jul2022; Covid RAT positive on 09Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 07Nov2021 as dose 1 (orange cap), single (Lot number: FK5127) intramuscular, in arm and on 21Nov2021 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 9 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "unknown" and all described as "Covid RAT positive on 09Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (09Jul2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300247428 same patient/drug/event, different dose;US-PFIZER INC-PV202300134420 same patient/drug, different event/dose;