chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is new to Medical Center. He declined influenza vaccine as he had nausea and vomiting in the past. It is unknown to provider when this side effect occur and at that time who prescribed influenza vaccine to patient. Since patient stated he had adverse event from influenza vaccine PCP enter as allergy into system.
Fever, chills, nausea, muscle aches/pain, headache, fatigue, inflammation at injection site.
On January 26, 2021,  identified a potential temperature excursion impacting a total of four hundred sixty (460) doses of Moderna vaccine. It is suspected that the vaccine was thawed from a  frozen state at the hub location (the "Hospital") and was transported to the vaccination clinic  (the "Clinic") approximately twenty (20) minutes away in a partially frozen state and subsequently refrozen at the Clinic.  Storage at Hospital When the vaccine was received at the Hospital from the distributor, it was stored in a freezer at a temperature of -25 degrees Celsius to -15 degrees Celsius. On January 20, 2021 and again on January 22,
recv vax;pain,malaise;early lyme disease;Mri=disc dehydration;epstein Barr IgG,IgM antibodies=633,99;urinalysis sl white/red blood cells,moderate blood;inc in pmns;abnl adnexal cyst;pain in lower legs,back;tenderness of sacroiliac joint;
post herpetic neuralgia; multiple outbrakes of herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers a female patient of an unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the pt was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster -related conditions. On an unknown date, the pt was administered zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) by a pharmacy team member. The pt suffered the following injuries and was diagnosed on an unspecified dates as a result of the zoster vaccine live (ZOSTAVAX) vaccine: multiple outbreaks of herpes zoster and post herpetic neuralgia. The outcome of the events was unknown. The causality was related.
negative antibody tests; anti-HBs antibody negative; This spontaneous report was received from a patient referring to herself, a female patient of unknown age.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and with hepatitis b vaccine (recombinant) (manufacturer unknown) for prophylaxis (dose, route of administration, frequency, lot/batch # and expiration date were not reported).   The reporter referred that she had a known condition in which she did not produce antibodies to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and with hepatitis b vaccine (recombinant) (manufacturer unknown). The patient stated she had had the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine four times (unknown dates) and still tested negative for antibodies. She also reported that she had also been vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) three times with boosters, and also still tested negative for antibodies.  It was also reported that her mother also did not make antibodies to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine (linked case # US-009507513-2108USA001036).  It was reported that the patient was vaccinated with PFIZER-BIONTECH COVID-19 VACCINE and finish her scheme of two doses in June 2021 (reported as "this year").  The outcome of antibody test negative and hepatitis b surface antibody negative was unknown.  No further clarify.   This one of two reports from the same reporter.; Sender's Comments:  US-009507513-2108USA001036:
Ras covering entire body, including arms, legs, thighs, stomach, and chest.  Treated at urgent care with prednisone and loratadine.  On 1/22/2021 rash has been resolved. Urgent Care ran a battery of blood tests at time of visi.  Photographic depiction of body rash was forwarded to MD.  Discussions are on-going as to
Patient developed palpitations and dizziness two days after 2nd Pfizer COVID-19 dose (4/5/21) and then  had sustained ventricular tachycardia requiring cardioversion 4 days later. Cardiac MRI was normal (no evidence of myocarditis). Underwent successful ablation of right ventricular outflow tract ventricular tachycardia on 4/12/21. Has been event free since. No history of palpitations or premature beats prior to vaccine. No family history of arrhythmias.
Five days after vaccine, noticed slight itching at injection site, continued off and on until tonight, the seventh day after the vaccine, the injection site itchy and became red and swollen;  looks like an elevated hive 1.5 inches across arm and 1 inch in height.  Site is warm to touch.
severe COPD exacerbation; severe COPD exacerbation; severe COPD exacerbation; oxygen 24/7; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN THERAPY (oxygen 24/7), the first episode of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (severe COPD exacerbation), the second episode of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (severe COPD exacerbation) and the third episode of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (severe COPD exacerbation) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Respiratory syncytial virus infection (Patient had RSV February 2019 at 75 years old, with COPD, and CHF which almost killed the patient.) in February 2019 and Congestive heart failure (Patient had RSV February 2019 at 75 years old, with COPD, and CHF which almost killed Patient.) in February 2019. Concurrent medical conditions included COPD (Patient had RSV February 2019 at 75 years old, with COPD, and CHF which almost killed patient.) since February 2019.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced the first episode of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (severe COPD exacerbation). On 21-Apr-2021, the patient experienced the second episode of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (severe COPD exacerbation). On 28-Apr-2021, the patient experienced the third episode of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (severe COPD exacerbation). In 2021, the patient experienced OXYGEN THERAPY (oxygen 24/7). The patient was treated with OXYGEN for COPD exacerbation, at an unspecified dose and frequency. At the time of the report, OXYGEN THERAPY (oxygen 24/7) and the last episode of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (severe COPD exacerbation) outcome was unknown.            No concomitant medications provided. No treatment information provided. On 10-APR-2021, 21-APR-2021, and 28-APR-2021, the patient had severe COPD exacerbation. At the time of this report. the patient had oxygen 24/7 and patient blames the vaccines.  Company comment: This case concerns a 75 year-old male patient with history of COPD, who experienced the unexpected non-serious events of COPD exacerbation (x3) and Oxygen therapy. The events occurred within a month of the second dose of mRNA-1273 vaccine. The underlying history of COPD likely contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 75 year-old male patient with history of COPD, who experienced the unexpected non-serious events of COPD exacerbation (x3) and Oxygen therapy. The events occurred within a month of the second dose of mRNA-1273 vaccine. The underlying history of COPD likely contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vaccines taken 4-13-07 AM. During that night I had pain heat in the right arm > unable to sleep. 4-14-07 unable to go to work arm and Lymphoids were swallow, painful and hot. Took ibuprofen. Called office -was advised to apply heat and exercise. 4-15-07 went to work> unable to lift arm
headache all night; This is a spontaneous report from a contactable consumer (reporting for herself). A female patient of an unspecified age received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took for covid-19 immunisation. It was stated that when probed to determine her reporter type, the caller mentions she worked with a doctor year ago, but was never licensed as a healthcare professional herself. Yesterday, she received her second dose of Pfizer's covid vaccine. She asks if she can take her blood pressure medication and cholesterol medications and all those medications now. The patient asks what she take for a headache that she had all night. Caller was informed medical advice cannot be provided. She would need to speak with her doctor. The caller mentions she tried to get in touch with her doctor before, but she will try again. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt c/o throat throat itching, , Benadryl given. Epipen given after no resolution and for c/o chest tightness and sob.  EMS galled to evaluate, refused transport
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMINS NOS for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 08-Mar-2021, DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I got a little dizzy within 15 minutes, but it let up so they let me go. About 7 hours later, I started getting chills and nausea. I dozed off, and when I woke up, I was extremely nauseous and dizzy. So much so that i almost passed out. I tried to walk to the bathroom and fell down. It felt like my legs weren't working. When I tried to get back in bed, I collapsed on the floor and was sweating and freezing at the same time. My heart was racing as well. I fell back to sleep and a few hours later, I was able to walk a bit better. Sunday, my temp hovered around 99.8 for a few hours and then started dropping, and I was feeling better.
hives, shortness of breath, lung congestion, severe hypotension, light head, cough, tongue itching, fever and SOB.
Presented to ER with c/o pain in left arm, unable to raise arm, headache, throat swelling, mild SOB, dizzy. Temp to 101, cough, sneezing. Diagnosis - acute URI with local reaction to Pneumovax. Patient given Darvocet, Benadryl and Albuterol med nebulizer. Discharged home.
Nausea morning after, extending through second day after Dizziness  Ears felt congested  Hot flashes  Treatment: rest, fluids, took time off work
PATIENT WOKE UP WITH HIVES THE MORNING AFTER VACCINATION. THEY STARTED ON THE SHOT ARM AND SPREAD FROM THERE. PATIENT REACHED OUT TO MD AND IS TAKING ZYRTEC.
When patient got home a few hours after shot he noticed swelling and tenderness at the site of injection.
expired vaccine administered with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Agency (00814725).  This case involves a 49-years old female patient who was vaccinated with expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 03-Sep-2021, the patient received 0.5 mL (total; standard) dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2017 and expiry date 30-Jun-2021) via an intramuscular route at the left deltoid for prophylactic vaccination.  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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.
Skin reaction; Swelling of face; Dry skin; Tight skin; Rash on neck; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 09:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, the patient experienced skin reaction, rash on neck, swelling of face, dry and tight skin.  Adverse events resulted in doctor/other health care professional office/clinic visit. The patient received treatment for the events with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events skin reaction, rash on neck, swelling of face, dry and tight skin was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient came to drive through vaccination clinic on 04/11/2021 and inadvertently received the  COVID-19 Johnson and Johnson vaccination, patient was too young to receive the vaccination at time of administration.
Unspecified AE after 1st booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Unspecified AE after 1st booster) 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.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced IMMUNISATION REACTION (Unspecified AE after 1st booster). At the time of the report, IMMUNISATION REACTION (Unspecified AE after 1st booster) had not resolved.            No concomitant medications were reported.  The patient received unknown treatment after AEs from 1st booster.   This case was linked to MOD-2022-675837 (Patient Link).
Pt recvd vax on 30APR92 & devel fever on 7MAY92 that lasted x 4 days a/presenting MD; mom also noted fine rash on pt starting on 10MAY92;
Patient said at time of Abilify injection he has experienced partial blurred vision out of right eye on right side. He described it as "seeing like he is in the movie Abyss".  I told him blurred vision is a side effect of the COVID vaccine and I would report it due to minimal studies with abilify and covid vaccinations.
I became COVID positive 18Aug; I became COVID positive 18Aug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "recovered" and all described as "I became COVID positive 18Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) Positive, notes: I became COVID positive 18Aug.  Clinical course: patient became Covid positive 18Aug. After feeling mild-moderate symptoms for 36 hours, patient was back on feet.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 11PM on the day that I got the shot, I started getting dizzy and a really bad headache and fatigued until I took acetaminophen. Same for Wednesday, 04/27. I slept the entire day. Headache, dizzy, fatigued. I was fine the 28th until Monday, the 2nd of May. Dizzy, headache, fatigue. Tuesday, May 3rd, I slept a lot. Dizzy, fatigue, headache. Medications: acetaminophen, Aleve, ice packs. My arm did hurt on Wednesday, 04/27. General other effects: face flushing, general body inflammation.
Patient was given covid-19 Booster Moderna on 12/6/21.  Patient was consulted at the consultation window before the vaccine was given.  Pharmacist confirmed with patient and mom that pt is expecting Moderna Booster.  We went over side effects that included soreness/redness/inflammation/bruising at injection site that goes away in a few days, covid-like symptoms such as body ache, tiredness, low fever, headache, shivering, chills, and warned patient of the very rare but severe side effects of myocarditis and pericarditis that occurs mostly in men less than 30 years old. Pharmacist informed the patient to seek medical attention if any chest pain, shortness of breath, and heart flutter.  Once in the consultation room, the patient was seated and asked to confirm the name, date of birth, name of the vaccine that patient's getting.  Pharmacist applied alcohol and asked the patient for his age, and as soon as the patient told his age pharmacist had injected the shot.  Pharmacist then realized that pt was not of sufficient age and asked the patient to stay for monitoring.  After his mom returned, pharmacist informed both the patient and his mom that the vaccine booster has not been approved for patients under 18.  Pharmacist went over all the side-effects again and talked about the risks. The mom also asked how long they should monitor for myocarditis and pericarditis, and pharmacist replied usually one to two weeks.  pharmacist recommended that the patient should make an appointment with the doctor to follow up.  Patient left after 15 minutes and did not have allergic reactions. Pharmacist called today~12pm (12/7/21) to follow up with the patient. The patient's mom answered the phone and said pt's having symptoms that were discussed yesterday.  Her son had a fever for around 25min at 3am, complained of ache and took tylenol.  He still decided to go to school this morning.  Mom also stated the patient texted her from school stating he was feeling tired, wanted to sleep and felt  "cold".   She stated she's already made a doctor's appointment for him on 12/8/21 at 345pm.  I asked her permission to call her again to follow up and will be expecting next call on Thursday 12/9/21.
Sore arm, headache, slight fever, nausea, body aches, and prominent dark black/blue circles around my eyes with extremely puffy eyes.  The above symptoms except for eyes resolved in about 4 to 5 days.  Eyes are still somewhat more prominently darker and puffy currently, but feeling well.  Virtual visit with doctor regarding my eyes, sent picture of my eyes:  Stated possible immune stimulation coagulation response with dehydration, consume more fluids which I did.  Feeling well at present.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, lot #, expiration date were not reported). On the same day after returning home, the patient passed out in the bathroom. The outcome of the event and the relatedness between the event and GARDASIL 9 were not reported. Upon internal review the event of "passed out" was determined to be medically significant. Additional information has been requested.
this is 1 of 3 pt from this site to devel a rash @ the inj site p/vax;rash resolved spontaneously p/3 days;
generalized muscle and joint pain, extreme fatigue, shortness of breath, pain at insertion site, lymphadenopathy axillary and supraclavicular on site of infection, headache
Patient found cyanotic in crib and dead on 3/25/08 7/10/08-autopsy report received-COD: positional asphyxia. Accident, prone face down positiong on soft bedding in crib.
LOUD TINNITUS IN BOTH EARS; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included tinnitus episodes, and concurrent conditions included penicillin allergy, and hear aid user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 2051A211A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced loud tinnitus in both ears. On 05-JUN-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loud tinnitus in both ears, and lightheadedness. This report was non-serious.
When I awoke that morning, the injection site was very swollen, the area being about 5 inches in diameter. Under the exact point of needle-entrance, there was a large-marble-sized hard lump. My entire arm itched, with intense itching around a five-inch area of the injection site. The next day, both arms were itching with a mild rash. About three days later, both legs began to itch intensely, with a rash on the fronts of both legs. The itching on my legs was SO intense that I could hardly stand it. I finally had to purchase medication designed for extreme itching. It helped somewhat, but until yesterday, the itching was HORRIBLE!!! I have cream that was prescribed to me by my physician. It is Desoximetasone (sp?). I mixed it with the anti-itch medication. The itch has gradually subsided... THANKFULLY!!! I'm not so sure I wouldn't rather have Shingles!!!