chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe chest pain; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 20Apr2021 13:00 as 1st dose, single for COVID-19 immunization. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included buspirone hydrochloride (BUSPIROL); and medroxyprogesterone acetate (DEPO PROGESTIN), both taken for an unspecified indication. The patient experienced severe chest pain (medically significant) on 22Apr2021 16:30. The adverse event resulted in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse event was pain medication. The outcome of the event was not recovered.   Information on the batch/lot number has been requested.
received her 2 doses (2 months apart)  / 3 years ago / had an outbreak of shingles 9 months ago/suspected vaccination failure; received her 2 doses (2 months apart)  / 3 years ago / had an outbreak of shingles 9 months ago; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient.   The patient received 2 doses 2 months apart of Shingrix 3 years ago and had an outbreak of shingles 9 months ago.  The reporter was inquiring if the patient should get another Shingrix vaccine.  The reporter did not consent to follow up. Limited information was obtained. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
pt recv vax 16FEB96 930AM & by 11AM pt was crying inconsolably & had stopped breathing twice;saw MD 1130AM & was monitored in office;no other problems in MD office;inconsolable crying lasted 8hr that day
Fatigue, Fevers, Painful Itchy Rash, Muscle aches and pains, Chest "stitch"
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer, the spouse of the patient.  A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 28Dec2020 (at the age of 62-years-old) as a single dose for COVID-19 immunization.   Medical history included ongoing lupus from an unknown date. Concomitant medications included unspecified medications for her Lupus.   On 08Jan2021, the patient tested positive for COVID-19. On 18Jan2021, the patient had an X-ray with unknown results. Therapeutic measures were taken as a result of testing positive for COVID-19 and included an unspecified infusion. The clinical outcome of tested positive for COVID-19 was unknown.
Patient is complaining of irritation on her arm. Redness and swelling at the injection site.
Itchy; slightly sore arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy) and PAIN IN EXTREMITY (slightly sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Flu.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 17-Mar-2021, the patient experienced PRURITUS (Itchy) and PAIN IN EXTREMITY (slightly sore arm). At the time of the report, PRURITUS (Itchy) and PAIN IN EXTREMITY (slightly sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Medication for high cholesterol was given as concomitant medication to the patient.No treatment medication included. patient denied further follow up.   This case was linked to US-MODERNATX, INC.-MOD-2021-079109 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received 20/05/2021 included TCR- No significant new information available. Patient denied further follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079109:
Muscle aches, joint pain, lower back and chest pain, pain at injection site, lymph nodes are seen popping out of skin, heart palpitations.
I developed redness, swelling and itching at the shot site  a  week after the vaccination. I felt off most of the day as if I was fighting something, but never got a fever. A red patch and soreness and itching developed at the vaccine site at about 1:00.
As per admissions, "Patient is a vaccinated 74 y.o. male who tested (+) for Covid-19 infection this evening and developed worsening SOB soon after. He is on 3L at home but it is not enough now. He is found to be hypoxic on 3L with pH 7.48 and pO2 54. He has been admitted for treatment". Acute on chronic respiratory failure with hypoxia Acute on Chronic Hypoxic Respiratory Failure - due to COVID-19 Pneumonia, Bacterial pneumonia superimposed.  Patient presented with shortness of breath, COVID-19 positive with infiltrates on CXR. He was started on remdesivir and steroids and received 4 days of treatment. He improved and was stable on his baseline requirement of 3L O2.  He was also treated with antibiotics for bacterial pneumonia given leukocytosis; WBCs improved. He will complete Omnicef and Decadron taper on discharge. AKI - Creatinine elevated to 1.6 on arrival, improved with IVFs. Resolved. Bradycardia - chronic. Cardiology evaluated, no indication for pacemaker. Asymptomatic. Mobitz 1 block, DM2.
w/in 6hr of vax pt devel fever to 101.7;had uncontrollable & inconsolable crying all noc;did not sleep all noc & would not take formula;red & puffy area both legs;
Initial information received on 13-Jul-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 16 years old female patient who experienced anaphylaxis, while she received vaccine ADACEL. The patients past medical history, medical treatment, concomitant medication and family history were not provided. On an unknown date, the patient received injection of first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, two years ago, the patient developed a serious anaphylaxis with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event. On an unknown date, two years ago, the patient developed a serious bradycardia with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event. Hospitalization details not provided. Lab data was not provided. Final diagnosis was anaphylaxis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for anaphylaxis and as Unknown for bradycardia. List of documents held by sender - none. Sender's Comments: This case concerns an adolescent patient who developed anaphylaxis after vaccination with ADACEL. The time to onset is unknown. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Patient was given 2 0.5ml doses of Moderna bivalent.    He also received the flu vaccine.  Patient was observed for 15 minutes after error and reported feeling no changes.
Patient was vaccinated on 4/27/2021.  Had high fever to 102 deg the next day. On  4/29/2021 patient had episodes of gross hematuria that caused her to seek care at an Urgent Care facility. Later was advised to go to ER due to unavailability of  results and need to rule out  bleeding.  Pt had normal CBC, normal platelets, normal PT/PTT, normal CK, renal ultrasound showing  normal kidneys , UA- LG blood, 20 protein. Pt was discharged from ER to follow up with  her doctor
Pt received her 1st Pfizer Covid vaccine on 3/17/21, but two days later she reported hives. Patient reported hives on both of her wrists, Later that day she noticed she had hives on her abdomen and back. That same day in the evening she took some Benadryl and the next day the hives had cleared.
Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms reported. No additional AE. Time frame: 65.2F for 9 Hours 45 Minutes , 32.4F for 42 Hours 45 minutes; This spontaneous safety report, with reference number 02430544, was received by a partner on 19-JUL-2023 and forwarded on 20-JUL-2023 and also significant additional information was received by a partner on 19-JUL-2023 and forwarded on 20-JUL-2023, from a HCP.   The causal relationship between Vaxelis and the reported event "Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms reported. No additional AE. Time frame: 65.2F for 9 Hours 45 Minutes, 32.4F for 42 Hours 45 minutes" was assessed as not applicable due to the nature of the event.  Further information is expected.  FOLLOW-UP information was received on 03-AUG-2023, from a physician. This case is maintained as non-serious.  The reporter confirmed that the patient did not experience an adverse event following the administration of Vaxelis after temperature excursion.  The causal relationship between VAXELIS and the reported event of "Inadvertent administration of VAXELIS and ROTATEQ after Temperature excursion. No symptoms reported. No additional AE. Time frame: 65.2F for 9 Hours 45 Minutes, 32.4F for 42 Hours 45 minutes" remained as not applicable due to the nature of the event.  Companion Cases: MCM-005053, MCM-005054, MCM-005056, MCM-005057, MCM-005058.  No further information is expected.
Received the FLU shot (type unknown) and the Zoster (Shingrix - part 1) shot on 9/28/2020.  The following day I started having headaches and craping. On 9/30/2020 I started experiencing some tingling in my right leg-thigh. The next day 10/1/2020, that night, I noticed blisters starting to form on my right butt, right thigh, back, and a small blister on my face. The following day, 10/2/2020, the blisters got worse and pain started to increase. The pain was like needles sticking into my skin in the blistered areas. On Saturday 10/3, after researching the symptoms it become obvious to me that I had the Shingles. On Sunday 10/4 I decide to go to ER-clinic to get diagnosed. The clinic diagnosed it as shingles.  The prescribed antiviral famciclovir.
Patient started feeling flushed about 30 min after vaccine and developed a headache about 6 hours after vaccine.  The morning following vaccine her headache continued and her blood pressure was 168/90. Day 3 168/106 . Day 4 170/106 and has stayed elevated since vaccine given.  Her BP was 154/70 in office today - 5 days after vaccine.  She is no longer having headache or flushing.  Her normal blood pressure is 110-120/70. Last elevated BP in office was in 2012 at 140/88.
that she is experiencing issues with the muscle activity with her eye lids to both of her eyes since receiving her last Moderna vaccination in October 2022; This spontaneous case was reported by a patient and describes the occurrence of EYELID IRRITATION (that she is experiencing issues with the muscle activity with her eye lids to both of her eyes since receiving her last Moderna vaccination in October 2022) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     Patient relevant medical history/conditions, allergy, concomitant diseases and risk factor was reported as unknown.     In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced EYELID IRRITATION (that she is experiencing issues with the muscle activity with her eye lids to both of her eyes since receiving her last Moderna vaccination in October 2022). At the time of the report, EYELID IRRITATION (that she is experiencing issues with the muscle activity with her eye lids to both of her eyes since receiving her last Moderna vaccination in October 2022) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided. Patient was having trouble with her muscle in the eye lids and already visited 8 doctors but nobody knows what was happening, but she knew it was because of the Moderna COVID-19 Vaccine.
21 y/o male ADSM with c/o previous reaction to Smallpox vaccine including right axilla adenopathy, right supraventricular, axillary pain and right arm pain. Symptoms: Lymphadenopathy, axillary, Pain, Fatigue, Malaise <60 Days.
6YO experienced inject site rxn which included swelling & erythema approx 2-3' diameter; 6 days p/inadvertantly receiving adult TD instead of the Peds DT rash was blotchy but no tenderness or itching;
From elbow to shoulder, warm and swollen area, redness 3 varicella lesions on chest; Diagnosed with cellulitis.
Pt received HBV vaccine 6/20/02. Hospitalized 6/21/02. Renal failure.
At the injection site it is red and bruised which looks like a normal injection site reaction. But about 4-5 inches below the injection site on the left arm is a red thick band of skin (almost a rash) that is red and warm to the touch.
Round circle at injection site; Itching at injection site; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Round circle at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE ERYTHEMA (Red at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE MASS (Round circle at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE ERYTHEMA (Red at injection site). At the time of the report, INJECTION SITE MASS (Round circle at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE ERYTHEMA (Red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified medication for blood pressure. No treatment details were reported.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27 Apr 2021(TCR) included: No new information
c/o nausea, h/a, inc fever, redness to inject site, tingling to tongue, ringing in ears, SOB; was taken to ER;
10 minutes after immunization, developed scratchy throat and cough which resolved with 10 mg Zyrtec. 2 hours after immunization, developed flat and urticarial rash on face, hands, and torso as well as chest tightness/dyspnea and headache. Dyspnea resolved in 3 days; rash persisted for almost 3 weeks.
I had extreme tiredness, almost felt like I had the flu. I couldn't get out of bed for 2 days, I felt really achy the days after receiving my vaccine. I had extreme fatigue. I contacted my doctor who advised me to take some pain relievers to aid my pain; so I took some Tylenol to help reduce the aches and aid my fatigue and rested.
Seizure, Taken to Christiana Hospital, Newark, De Followed up w/Neurologist, Several seizures since, medicated.
Patient presented to Health Dept requesting TDAP - denied having TD in last 5 years.  NCIR unable to see record.  TDAP given then once NCIR accessible saw TDAP given 4/14/08 - patient unaware of this, when notified.  No complications.
Fever, variable between 100.1 & 102.5 on the same day as shots, also runny nose cough.
No adverse event; Patient received 1st dose on 30-Apr-2021/second dose on 04-Jun-2021/received second dose at day 36; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Apr-2021/second dose on 04-Jun-2021/received second dose at day 36) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     There was no reported medical history.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Apr-2021/second dose on 04-Jun-2021/received second dose at day 36). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Apr-2021/second dose on 04-Jun-2021/received second dose at day 36) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-619230 (Patient Link).
Expected side effects were experienced for three days, including low grade fever, headache, stomach cramps. Fourth day and until now continued exhaustion not relieved by sleeping 8 hours plus intermittent napping.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well). At the time of the report, ILLNESS (get a bit sick every time I get a vaccine and with many medications however has been worse than before) had not resolved and MALAISE (Currently in a more symptomatic state as a result of the general malaise, this occurred prior with two shot series as well) outcome was unknown. mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged. Concomitant medications details were not reported by the reporter. It was reported that as per the medical history patient did check with her doctor first and the doctor felt that it was better to get the shot than not. Treatment details were not reported by the reporter. This case was linked to MOD-2022-529920, MOD-2022-529919 (Patient Link).
The patient was administered an expired Menactra vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (GMI) (Reference number- 00555170) and transmitted to Sanofi on 09-Apr-2021.  This case involves a patient (demographics unknown) who was administered an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6565AA, expiry date: 28-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day)  At the time of report, no adverse event was reported  The reporter had an incident where a patient was given an expired Menactra vaccine in one of the clinics. They were looking for documentation on whether or not the patient needs to be revaccinated..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
10MAR97 wheezing, cough, t103 placed on biaxin;mom states taking to MD 18MAR97 chest sounds worse;
I took my booster on 11/24/2021. On Dec 17th I had sharp ringing in ears and felt dizzy. Dizzy never happened again but the ringing is on continuously, Not sure if its the side effect of the vaccine taken.
Very bad leftside  pain ,stomach pain, vomiting, diarrhea ,fever, weakness, fatigue, lack of appetite constipation. This happened 2 weeks after the shot still going experiance systems. Blood in stool
Patient diagnosed with mild cognitive impairment approximately September 2021 and on October 20, 2022 diagnosed with Alzheimer's disease. Symptoms include dementia, memory impairment, mental impairment, cognitive disorder, disturbance in attention, and loss of personal independence in daily activities.
PATIENT RECEIVED MODERNA VACCINE ON 03/18/21 CAME IN ON 04/21/21 TO GET SECOND DOSE.  PATIENT RECIEVED PFIZER INSTEAD OF MODERNA VACCINE AS SECOND DOSE.  BEFORE ADMINISTRATION,  NURSE SAYS SHE VERIFED WITH PATIENT THAT HE WAS TO GET PFIZER.  LATER PATIENT BROUGHT IN VACCINATION CARD AND STAFF NOTICED HE HAD RECEIVED MODERNA AS FIRST DOSE AND NOT PFIZER.
Within three days after the second shot, I started having headaches. Noting that I never get headaches. But every day after the second shot they have increased in severity. Now seems like I have a headache all day long and it's quite debilitating. Should I reach out to my doctor? I did have a change in my hormone replacement therapy prescription right around the same time. Insurance refuse to cover my prempro, and put me on Jinteli. Other than that change everything has remained the same.