chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I did not have an adverse reaction to the vaccine. I have a sports watch that indicated my heart was racing. I contacted a friend to take me to the emergency. It was determined that I was in AFIB, and they shocked me. I was in the emergency room for about 4 hours, and I went home. I had an appointment with a cardiologist on 03/09/2023. I am taking medication to help with my symptoms.
Case number PHEH2013US022645 is a combined initial and follow up spontaneous report from the physician and nurse received on 25 Oct 2013 and on 28 Oct 2013. This report refers to a 12-year-old male patient. She was vaccinated with MENVEO (batch number: A131012) intramuscularly on an unknown date. On 21 Oct 2013, 21 hours after vaccination he had a 20x10 cm irregular bordered ovaloid, raised erythematous hot urticarial response which was reported as localized. It was reported that the reaction did not get better and had not gotten any worse. He was recommended for ice and diphenhydramine. The outcome of the events reported as unchanged, 48 hours after the treatment. The seriousness of the events was not reported.
A few days after shot, I became suddenly near-deafened. I hear in only one ear and the middle-ear had filled with fluid.  I pursued medical care. Primary care doc and the ENT noted on this report denied could be related to vaccine despite my suspicions due to timing. I was told I coincidentally had been struck by a non-identifiable virus that attacks the ear just after having the shot.  I also had myelgias and brain fog for about a month to six weeks following the shot.   Allopathic doctors insisted the cause was viral and there was nothing to do but wait to see if I could recover hearing. Alternatively, I pursued care primarily through neuroacupuncture. Over the course of the next two months, fluid drained slowly and most of my hearing in that ear returned-- but it did not return to baseline.  I estimate that I lost 10-20%  of my hearing. I don't have a baseline hearing test close enough to or immediately after to verify that. But my hearing aid adjustments since suggest there was a noticeable hearing decline.  I wish to report the adverse event retrospectively given current evidence that covid vaccines can cause an auto-immune-like reaction in ears in some patients, so that my case can be counted in the evidence base.   There is no way to know how many patients' like me legitimate concern about bizarre health efects after shot were dismissed, so I suspect all data on this ear-related adverse effect are an undercount. I am a public health professional myself, so I know about the VAERs system.
Myalgia, Arthralgia, Nausea Vomiting, Dizziness, Brain fog Dizziness and brain fog 60 minutes after  vaccine
Tingling of the lips and tongue, thirst, patient received liquid Benadryl orally, went to hospital emergency room for further evaluation and treatment.
chills; injection site pain; This is a spontaneous report from a non-contactable other hcp. An elderly female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have any 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. On an unspecified date, the patient experienced injection site pain and chills. No therapeutic measures were taken as a result of the events. The clinical outcomes of the injection site pain and chills were resolved on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Presented w/ cough, tested Covid + prior to visit. Worsening edema legs/abdomen, SOB. R/o acute kidney injury, likely due to fluid imbalance d/t congestive heart failure
Dyspnea - Difficulty breathing at rest, felt like a weight was on her chest; Dyspnea - Difficulty breathing at rest, felt like a weight was on her chest; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the right arm on 27Mar2021 15:45 (03:45 PM) (lot number Er8732) as a single dose for COVID-19 immunization.  Medical history included asthma. The patient had no known allergies. Concomitant medication(s) included salbutamol sulfate (ALBUTEROL) and Breo (unspecified) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had no Covid prior to vaccination and has not had Covid tested post vaccination. The patient experienced dyspnea - difficulty breathing at rest, felt like a weight was on her chest on 28Mar2021 10:00 AM. Therapeutic measures were taken as a result of the events which included albuterol. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient received 2nd vaccine on left deltoid muscle at 01:05PM.   Patient advise the need to wait 15 minutes for any adverse reaction. Patient verbalized understanding. Patient asked if history of fainting patient stated when he was younger and has not fainted in a while, and his first COVID-19 vaccine was done in a drive-thru and he was fine. Patient was monitor for 5 mins after vaccine was given inside the room, when patient stated is was feeling dizzy and patient fainted at 01:10PM. Provider was called and made aware. Patient was move to provider room to be laid down with help of other nursing staff.  Vital sign taken at 01:15 PM BP 108/81 HR 75 SPo2 99% RR 18 patient stated he was feeling a bit better. Vital sign taken at 01:25 PM BP 106/79 HR 71 RR 16 Spo2 98%.  Patient stated he was better but was going to call Partner to come and pick him up. Vital sign at 01:35PM 123/81 HR 72 Spo2 98 % RR 16, patient stated he was much better. Patient was asked to sit on chair and stated he felt fine vital sign taken at 01:45 PM BP 128/87 RR 16 SPo2 97% HR 71. Vaccination record card and Fact sheet for vaccine provided to patient. Patient monitor for 30 minutes no adverse reaction noted. Patient left clinic stable with steady gait with Partner.
COVID-19/Tested COVID positive on 28-Dec-2021; Vaccination failure; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19/Tested COVID positive on 28-Dec-2021) and VACCINATION FAILURE (Vaccination failure) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21A and 014c21a) for COVID-19 vaccination.     The patient had no allergies (medications, food and other products). History relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination was reported as unknown. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (COVID-19/Tested COVID positive on 28-Dec-2021) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (COVID-19/Tested COVID positive on 28-Dec-2021) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the adverse event did not cause patient to seek medical care. The patient did not experienced a similar event in the past.   No treatment information was reported.  Company Comment: This spontaneous case concerns a 20-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred approximately 7 months after receiving the second dose of mRNA-1273 vaccine. The patient was tested positive for SARS-CoV-2 as on 28-Dec-2021. Vaccination failure/Lack of efficacy is also noted in this case as it satisfies the criteria of LOE (LOE noticed 15 days after the second dose and the interval between the two doses is around 25-35 days with Moderna vaccine). Ongoing Pandemic could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-527278 (Patient Link).; Sender's Comments: This spontaneous case concerns a 20-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred approximately 7 months after receiving the second dose of mRNA-1273 vaccine. The patient was tested positive for SARS-CoV-2 as on 28-Dec-2021. Vaccination failure/Lack of efficacy is also noted in this case as it satisfies the criteria of LOE (LOE noticed 15 days after the second dose and the interval between the two doses is around 25-35 days with Moderna vaccine). Ongoing Pandemic could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pain at injection site immediately, swelling around site, after about an hour, cold chills and a headache, body aches about 2 hours after
This spontaneous report was received from a certificated medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # M000592 with expiration date of 12-OCT-2017; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 119 hours 30 minutes at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 15-DEC-2016 to 13-JAN-2017, and a temperature excursion during 04 hours at a temperature between 32 degrees Fahrenheit and 35 degrees Fahrenheit (0 degrees Celsius and 1 degrees Celsius) (# cycles: 30) from 23-FEB-2017 to 24-MAR-2017. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA002259: US-009507513-1704USA008690:
A report has been received from a Pharmacist concerning a child, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Pharmacist incorrectly administered two doses of FLUMIST to a couple of children, in the past couple of weeks. The outcome of the event of administration of half dose of FLUMIST QUADRIVALENT to two children is unknown. The report was considered to be non-serious.
Patient is 17 years old and 11 months but received Moderna COVID vaccine which is not licensed for his age group.
Extreme headache, as bad as I has while sick with covid. Exhaustion, shortness of breath while talking
Hive; Swelling of the throat; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hive), PHARYNGEAL SWELLING (Swelling of the throat) and RASH (Rash) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced URTICARIA (Hive), PHARYNGEAL SWELLING (Swelling of the throat) and RASH (Rash). At the time of the report, URTICARIA (Hive), PHARYNGEAL SWELLING (Swelling of the throat) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Immediately after the vaccine was administered he began to feel lightheaded. Over the next 10 minutes he became dizzy, pale, diaphoretic, and hypotensive. He was moved to a supine position. Three attempts were made to place an IV, but was difficult to place due to history of drug use. He began to improve without IV fluids. Offered fluids and food. The symptoms began to resolve in a few minutes and within 20 minutes he felt back to baseline. He was observed in the medical area for the next hour.
Fever within 24 hours after 2nd dose of vaccine; Chills within 24 hours after 2nd dose of vaccine; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. 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 COVID-19 vaccination. On an unknown date, within 24 hours after the second dose, the patient experienced fever and chills. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The clinical outcome of the events fever and chills were resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache within 2 hours of the vaccination; This is a spontaneous report from a contactable consumer, the patient. A 43-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 left arm on 11Apr2021 at 12:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 14:00, the patient experienced headache within 2 hours of the vaccination. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache within 2 hours of the vaccination was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
lost her sense of taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "lost her sense of taste".  Additional information: Caller mentioned that they keep on sending her paperwork to fill out. She stated that, she lost her sense of taste after getting the booster shot. Stated that, while reading the opening spiel caller disconnected the call. No other information was mentioned after she stated that she lost her sense of taste. Created Manual AE form. Any medical questions addressed by this program forwarded/referred to Medical Information (Live Operators Only) was reported as no: Customer and/or medical inquiry was not forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 31Jul2021 15:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient's daughter and the patient, both got the vaccine yesterday at 3 o'clock. The rest of the day they felt good, no symptoms at all. Last night, they started with fever.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
LUMP AT INJECTION SITE, SHORTNESS OF BREATH, HEADACHE, FEVER, AND LEG PAIN
Covid-19; Covid-19; Dose Number 4: 07Dec2021; Dose Number 4: 07Dec2021; Dose Number 4: 07Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant), OFF LABEL USE (medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "Dose Number 4: 07Dec2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03May2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Negative, notes: Tested negative on 28Apr to 01May; (03May2022) Positive; (08May2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt is a 70 year old male who received first dose of Pfizer COVID-19 vaccine on 02/06/2021. Pt describes  that he was doing well for a few days after receiving the vaccine; however, on Friday February 12, 2021  pt states he began to feel poorly at dinner. His initial symptoms included back pain, myalgia, and  fatigue. Pt got tested for COVID-19 and received positive results on 02/14/2021. Pt presented to ER on  02/15/2021 due to weakness, dizziness, fatigue, and confusion. Pt also reports dry cough, fever, chills,  and loss of apetite. Pt was discharged on 02/16/2021 after improvement was observed.
"Rash at injection site, neck, face, upper trunk within first 5-10 minute(s) while in observation area after vaccine was given on 5/01/21.  No note indicating that a rescue med was used. Patient reports via translation, history of allergic to multiple medicines (PCN, Latex, sulfa, gentamycin) with anaphylactic reactions (rash, shortness of breath, swelling of throat)   Advise to get J&J vaccine 28 days after 1st dose Pfizer vaccine (ie, 5/29/21)   Patient doesn't want to get J&J vaccine, information was provided, patient will consider later. Pt returned for second dose on 5/22 and was turned away due to allergy.
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 2007, 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. Instead, the patient contracted a persistent strain of herpes zoster, or shingles. During 2016, the patient was treated by a physician, for the onset of a burning rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine and/or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering. Additional information has been requested.
Starting at 8 pm on 3/11 I had flu symptoms; fever, aches, headache neck ache. Had fever through night chills and sweats. This morning I noticed around 9 am I started to develop hives on my shoulders/back/neck/face and my ears are red.  I took 400 mg Aleve at 1:30 am 3/12, Tylenol 500 mg at 9 am and Benedryl at 11 am all on 3/12. My arms/shoulders/chest/neck feel itchy.
I received my 3rd dose of the vaccine on 09/27/2021. That evening I had those same body shaking, chills, intense nausea for 4 hours and my temperature was 100.7. On 09/28/2022 that night I had fierce abdominal pains and considered going to the ER. My temperature 100.2.  On 06/29/2022, I had an intense headache, I had body aches and fatigue for about 5-6 days. The fever disappeared after 4 days. I had mild fatigue into the second week.
Information has been received from a registered nurse concerning her a 31 year old niece with "one kidney from kidney disease" and no allergies who in June end or early July 2007 was vaccinated into shoulder bone with a 0.5 ml dose of Recombivax HB. Immediately after vaccination, the patient experienced extreme pain that was described as "like hot lead". The patient had minimal movement from the arm that was vaccinated and was under worker's comp. It was reported that at times the arm went numb. The patient was taking "massive" doses of ibuprofen (MOTRIN), doing physical therapy, and using hot/cold therapy to relieve the pain. An MRI from the area showed a cyst, which when biopsied was "a pocket of the vaccine at the shoulder joint within the bone". Calcification was found at and around the area of injection. A complete blood test, blood chemistry test and effective infiltration rate and was undertaken. At the time of report the patient had not recovered. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
MINOR COLD; SORE ARM; FATIGUE; CHILLS; FEELING HOT; This spontaneous report received from a consumer concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced feeling hot. On 10-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced minor cold, sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, and chills on 11-APR-2021, and minor cold, and had not recovered from sore arm, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210421646.