chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Breakthrough Case  Pfizer Dose 1 3/5/21 EN6199 Pfizer Dose 2 3/26/21 ER2613  CV+ 8/2/21  8/6/21 History is obtained from patient as well as a personal review of records.  Patient is 67-year-old gentleman with known history of hypertension, hyperlipidemia, nonobstructive coronary artery disease and other medical problems.  He had worsening subjective fever, nasal congestion, chills, fatigue for 10 days.  Was seen at doctor's office on 8/2/2021.  He had test done for  SARS-CoV-2 on that day. He tested positive.  He was prescribed doxycycline, benzonatate and prednisone.  He came to emergency department as his breathing became worse.  Was hypoxic. Felt better after started on BiPAP.
06/07/02 client called c/o feeling crampy all over, dizzy and fingers locking up. Thought he may have had some fever, but had not taken temp. Advised him to see a doctor or go to ER.
SWOLLEN RIGHT LEG; PAIN IN CALF AREA; RIGHT TEMPORAL PAIN/HEADACHE; HORRIBLE STOMACH PAIN; PLATELET LEVEL DROPPED 10 POINTS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced platelet level dropped 10 points. On APR-2021, the subject experienced horrible stomach pain. Laboratory data included: Platelet count (NR: not provided) no findings, dropped 10 point, and Ultrasound scan (NR: not provided) no findings. On 11-APR-2021, the subject experienced swollen right leg. On 11-APR-2021, the subject experienced pain in calf area. On 11-APR-2021, the subject experienced right temporal pain/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen right leg, pain in calf area, and right temporal pain/headache, and the outcome of platelet level dropped 10 points and horrible stomach pain was not reported. This report was non-serious. This case, from the same reporter is linked to.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
feeling crappy/feeling bad; chills; felt clammy and was sweating; was unsteady and couldn't stand to cut the grass / wasn't as easy on his feet and out of balance; couldn't stand to cut the grass; after receiving the vaccine the ringing in his ears also came back and was getting worse as well; This is a spontaneous report received from a contactable consumer reporting for himself. This 62-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date in 2021, for COVID-19 immunization. Medical history included COVID in Dec2020 and he had ringing in his ears, also known as tinnitus, and this was clearing up and almost gone. Concomitant medications were not reported. The patient felt okay on 10Apr2021 but was unsteady and couldn't stand to cut the grass. The patient wasn't as easy on his feet and out of balance and this was his only symptom on 10Apr2021. On 11Apr2021 the patient was feeling crappy and wanted to know if he should go to the hospital. When he went to church on 11Apr2021 morning he began feeling bad and almost left because he had chills, felt clammy and was sweating. He had COVID in Dec2020 and he had ringing in his ears also known as tinnitus and this was clearing up and almost gone but after receiving the vaccine the ringing in his ears also came back and was getting worse as well. His doctor told him that people who had COVID prior to receiving the vaccine may have an increased immune response and he guessed that it was what was taking place with him currently but he did not like it and did not want to go through it again with the second dose. Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a Registered Nurse refers to a 20 year old patient of unknown gender. Information on concurrent conditions and concomitant medications was not provided. The nurse stated that a patient received the first dose in the series of three of GARDASIL on an unspecified day in July 2013, and received the second dose on 10-JUL-2015 (intramuscular, dose, site of administration and lot # not provided). No adverse events were reported. Additional information has been requested.
The patient received a pediatric dose of 10ug lot FK5618 due to vaccinator error. vaccinator noticed the error immediately. We communicated with the patient, nurse lead, pharmacist, operation clinic manager. We completed the full adult booster dose with adult Pfizer lot FJ 1620 by administering 20ug more. Total of 30ug was given to the patient on the same left arm but different site.
This spontaneous case reported by a consumer, describes the occurrence of rash on neck chest and sides in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 008C21A) for COVID-19 immunization. Previously administered products included for an unreported indication: COVID-19 Moderna vaccine (dose 1) on Apr 13, 2021. On May 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 12, 2021, patient experienced rash on neck chest and sides. At the time of the report, rash on neck chest and sides outcome: unknown. Symptoms are not painful or bothersome, patient was looking for treatment options.
Large red rash similar to COVID arm side effect appeared at the injection site. This was almost a week later.
Papular, erythemic cluster (some with whiteheads, not vesicular, developed 4 days after VARIVAX at site of injection.
Developed Dress Syndome, Also rash covering 60/70% of my body , Fluctuating blood pressure , Plus tumor andd Lieomyo Sarcoma. Recently vision problem which MD states could be caused by adverse reaction to vaccine.
I suffered a sudden temporary onset of hearing loss in my left ear which happened within a few hours after receiving the Covid Moderna Booster vaccine.  The hearing loss happened 7 hours after receiving the Covid Moderna booster on 11/9/2021 at clinic. I called the clinic the evening of 11/9/2021 at approximately 6 pm and based on my symptoms was prescibed prednisone (steroid) by phone call from Dr. for 7 days if needed.  However, my hearing returned the next morning.  But, I suffered from tinnitus for the next few days afterwards.  I am feeling better now and my hearing has returned.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case is linked to case 2018SA301024 (Same reporter). This case involves a female patient of unknown age who received an expired dose of vaccine FLUZONE (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to expired vaccine used. It was not reported that if the patient experienced any adverse event or not. 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. Documents held by sender: none.
Redness, tenderness, swollen inflamed upper right arm chills, nausea, itchiness.
The day after receiving the 2nd Covid Pfizer-BioNTech dose I began to feel fatigued, had an elevated temperature of 99.5, and soreness at the injection site. It has been 4 days since the 2nd dose and my temperature is still elevated at 99.5, I have a persistent headache and soreness of the muscles between my shoulder blades.
Nausea, body/joint aches, headache. All symptoms began approximately 7:30 PM on the same day of the vaccination and lasted approximately 24 hours. Symptoms were at their peak at approximately 12:30 AM - 3:00 AM on 3/14.
Case number PHEH2014US025016 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 52 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that before administration, the FLUVIRIN had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures were in between 46 to 49 degree F. No adverse event was reported following this maladministration.
dizziness; a little confused; warm feeling through out her body; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness), CONFUSIONAL STATE (a little confused) and FEELING HOT (warm feeling through out her body) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ARIPIPRAZOLE (ABILIFY) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (dizziness), CONFUSIONAL STATE (a little confused) and FEELING HOT (warm feeling through out her body). At the time of the report, DIZZINESS (dizziness), CONFUSIONAL STATE (a little confused) and FEELING HOT (warm feeling through out her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol
This spontaneous report was received from a pharmacist via company representative regarding to 2 male patients in their 50's (years old). Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates approximately in 2016, the patients were vaccinated with ZOSTAVAX vial (doses, frequencies and routes were unknown). On an unknown dates in JUNE 2016 reported as in the last month, the patients experienced injection site reactions after receipt of the ZOSTAVAX. The outcome of injection site reactions were reported as recovered/resolved. The reporter did not provide the causality assessment for the adverse event. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sore throat; Cold symptoms; Fever of 101; Throwing up; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 23Jul2021 at 15:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (Adhd) and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Jul2021 at 02:45, the patient experienced fever of 101 (units unspecified), throwing up, sore throat and cold symptoms. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of event fever 101 (units unspecified), throwing up, sore throat and cold symptoms were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected
Throat/tongue swelling/ difficulty swallowing. Refused epi.  Called for EMS - transported to ER
Around 7pm June 5th, temperature spiked above 101 degrees, I became very dizzy, fatigued, and full-body achy. With particular pain in my back and neck, and some shooting pains in my lower abdomen. I had a syncope spell around 9pm, roughly 12 hours after the injection, and noticed a red painful lesion at the injection site on my right arm as well. I have been taking Tylenol to keep the fever down and hydrating/resting as much as possible, as well as a cold compress on the injection site to help bring down swelling and pain. I?m hopeful these symptoms will resolve themselves in the next couple days.
Migraine; Nausea; Vomiting; Muscle Aches; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had these symptoms including migraine, nausea/vomiting, muscle aches and diarrhea starting 24-72 hours after her injection on Apr2021. The outcome of these events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Felt tired and achyo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Jun2021 04:15 (Lot number: EP6955) at the age of 15 years as dose 2, single and intramuscular, administered in arm left, administration date 27May2021 04:30 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 18Jun2021 12:00, outcome "recovered" (2021), described as "Felt tired and achyo". Therapeutic measures were not taken as a result of fatigue.  Additional information: Patient did not received any other vaccine within 4 weeks of vaccination. Patient did not received any other medications. Patient was not tested for Covid prior to vaccination. Patient was not tested positive for Covid-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Missed Dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed Dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 PRODUCT DOSE OMISSION ISSUE (Missed Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was hospitalized at the time he was supposed to receive the second dose. Caller states the hospitalization is not vaccine or COVID related. He was already a sick individual with a past medical history that resulted in hospitalization. Caller states the medical director advises on giving the second dose at this time. No further information provided as caller did not elaborate on the event as he did not feel it was vaccine related.  No concomitant medications were reported No treatment drugs were reported
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2012, the patient was treated by a physician for a vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Tachycardia; Shortness of breath; Arm soreness; Headache; Redness around injection site; Small bumps around the injection site; Pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), TACHYCARDIA (Tachycardia), DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 020M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IRON and ASCORBIC ACID, FERROUS FUMARATE, FOLIC ACID, RETINOL (PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 01-Apr-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 06-Jan-2021, the patient experienced TACHYCARDIA (Tachycardia), DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE RASH (Small bumps around the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) for Headache, at an unspecified dose and frequency. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), TACHYCARDIA (Tachycardia), DYSPNOEA (Shortness of breath), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE RASH (Small bumps around the injection site) outcome was unknown and PAIN IN EXTREMITY (Arm soreness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included Butalbital-Acetaminophen-Caffeine for unknown indication.  Treatment medication Butalbital-Acetaminophen-Caffeine was taken after the second dose.; Sender's Comments: This case concerns a 30 year-old, female patient, who experienced an event of exposure during pregnancy after receiving her first and second dose of mRNA-1273 vaccine.  In addition, the patient experienced arm soreness, headache, shortness of breath, tachycardia, redness around injection site, and small bumps around the injection site after her first dose of mRNA-1273 and experienced headache after her second dose. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
PATIENT REPORTS  INTERMITTENT LOWER LEFT UNDERARM/RIB PAIN  AND TIGHTNESS OF CHEST (SHORT DURATION)
Patient reports via phone that she experienced the following symptoms approximately 11 hours after vaccination: neck/throat swelling, shortness of breath, and vision changes.  Patient presented to an emergency department and states she was treated with Benadryl and symptoms improved enough to be discharged.  Patient states ER staff recommended she be tested for covid-19 infection, but was advised that test would not be accurate that day as she had just been vaccinated.   Patient states she is still feeling "off" 5 days later and will go to an urgent care to be evaluated.
Diagnosed with Bells Palsy, treated with  antiviral (acyclovir 400 mg 5 times a day for 10 days) and predniSONE 20 mg 3 oral tabs once a day.
Pt recvd MMR vax on 16MAR92 & 2 days later devel sl pruritic acne-type rash w/small 3 to 4 mm papules; t102 & dec appetite; pt denied any cough, coryza or conjunctivitis;
Numbness of right side of face. No treatment sought at this time. Still some numbness 5 hours after shot.
The patient states that every time she has gotten a flu vaccine since 1996 the same thing happens a few days later; the end of her nose gets red and swollen, one or two days later the skin has clear liquid beneath it which drips out and the skin comes off a couple of days later when she washes her face. The area stays raw and bleeds every time it is touched for up to 2 months before it finally heals. The dermatologist diagnosed the lesion as a brown recluse spider bite.
Red swollen/itchy eyes- first symptom started before I left the clinic. Brain fog, pain in lower right side, throwing up, dizziness- all these symptoms began within an hour after receiving the vaccine. Went to bed, woke up at 1 in the morning with a feeling like I was shaking so badly that I couldn't fully expand my lungs to breathe, extreme dizziness, and a weak, fluttery heartbeat. Went back to bed, awoke with a pounding headache, dizziness still present but not as extreme, very nauseous, had strange heartbeat episodes throughout the day, coughing, dizziness subsided about 24 hours after vaccination, headache lessened but took longer to mostly go away, one more shaking incident happened at 9:30 am 8/13 lasted about fifteen minutes but without the breathing issues and dizziness,48 hours after vaccination heartbeat episodes have stopped and most issues are gone expect for fatigue, nausea, and the sore arm.