chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a female who on 08-OCT-2007 was vaccinated with GARDASIL vaccine (yeast). On 09-OCT-2007 the patient developed heart palpitations, pain and itching on the arm but not at the injection site (arm not specified). The patient did receive unspecified medical attention. At the time of this report, the patient's heart palpitations, pain and itching on their arm is persisting per the nurse. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. No additional information is expected.
After the patient waited her 15 minutes, she left the pharmacy by driving her vehicle. While in her vehicle, she was stopped at a stop light and thinks she fainted or blacked out. She woke up in the middle of the intersection and was able to hit the gas before she was hit by another car. She did not go anywhere for treatment and has not experienced the same side effect since that time.
Severe pain in shoulder, down arm to hand. Numbness and tingling in arm, shoulder and hand.
Her eyes are swollen and red; Her eyes are swollen and red; This is a spontaneous report from a contactable consumer (parent).   A 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0176), via an unspecified route of administration, administered in Arm Left on 09Jun2021 about after 3pm (13-years age at the time of vaccination) as single dose for covid-19 immunisation. Medical history was provided none. There were no concomitant medications. Consumer reported that patient have vaccine yesterday then on 11Jun2021 patients eyes were swollen, and red. The patient did not receive any treatment for adverse events. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
6 hours of inconsolable crying; onset 1 hour from immunizations. No fevers, no neurological illness; now recovered completely. No treatment provided.
12/30/22 presents to ED for "cough" "chest pain". PMHx of "COPD, hypertension, GERD, DM type II, hepatitis C, hypercholesterolemia, CAD"
Complains of arm pain for two weeks.  No numbness or tingling to extremity.
2-3 days p/vax pt devel t102 & became nauseated (lasted 1 noc); several nocs p/exp achiness, & stomache pains; no redness, swelling, or warmth to the inject site;
Redness at site progressing to redness around upper arm, tenderness, slight swelling.
3" diameter round area on left area where vaccine given red, slightly swollen, oral temp 101.0 on 8/24/05 but returned to normal 8/25/05; itching resolved 8/25/05; redness resolved 8/25/05; sxs treated with Tylenol, Benadryl, cool packs, comfort measures; denied need to see MD.
Narrative: COVID infection following completion of COVID vaccine series 02/25/21 COVID vaccine dose #1 03/27/21 COVID vaccine dose #2 08/02/21 Pt presents to screening reporting exposure to COVID positive daughter and symptoms of cough, fever, and runny nose since 07/30; COVID POSITIVE 08/03/21 Pt reports all symptoms have resolved - chills, cough, diarrhea, loss of taste/smell, muscle pain, runny nose, sore throat; states runny nose started 07/29
pt recv vax 16JUL96 & 20JUL96 pt exp three little bumps on lower arm near wrist & two near ankle;also felt h/a & nauseated;
About 10 minutes after the second dose, I noticed the hives and irritation come on my throat, neck and my arm. I talked to the people who were monitoring and they gave me 50 mg of Benadryl and they kept me for 45- one hour. They Benadryl took about 20-30 minutes to for having the hives and irritation go away. After that happened, I went home and I started to get body aches and feeling very fatigued; a little bit nauseous.  I did have some soreness and swelling on my arm after vaccine that lasted two or three days. The fatigue and body aches lasted for one day. The hives and irritation on my throat and neck and arm didn't come back after the dose of Benadryl.  I had a doctor appt on Feb 8 about the side affects of the vaccine - he told me if hives came back to take Benadryl.
Information has been received from a female physician with a history of mumps who in 1005 was vaccinated with the first and second doses of varicella virus vaccine live. The physician indicated that she experienced a negative titer at that time. It was also noted that in 2002 the physician was vaccinated with the third and fourth doses of varicella virus vaccine live. The physician stated that she had "mumps" and "maybe her immunity is low". Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
The night of vaccination (12/28/20), pt developed mental "fogginess" with impaired alertness, remained oriented x4. She saw her primary care physician who ordered bloodwork and a brain MRI. On 1/8/21 pt reported that the mental fogginess had improved but she had developed a rash at the injection site. The rash cleared by 1/14/21.
This spontaneous report was received from a physician, concerning female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 06-MAY-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration lot number and expiration date were not reported). On an unknown date the patient experienced joint pain, severe anxiety, muscle issues, and abdominal issues. At the time of reporting, the outcome of joint pain, severe anxiety, muscle issues and abdominal issues was unknown. The causal relationship between the vaccination with GARDASIL 9 and the events was not provided by the reporting physician. This is one of two reports received from the same reporter; who had a concern that this would suggest something hereditary. Sender's Comments: US-009507513-1804USA006142.
Myalgia & Arthralgia Narrative:  Headache, arthralgia, myalgia; recovered.  Other Relevant History:
Cannot extend arm outward or upward without cringing in pain; Cannot extend arm outward or upward without cringing in pain; Muscle in arm that took injection aches; Inflammation like the vaccine "flipped a switch" triggering re-emergence of sciatica & heightened arthritic pain in toes, ankles and fingers; Worst seasonal allergies ever; acute sinus infection; urinary tract infection; Elevated HA1C; Extreme muscular ache & burning; joint pain; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731) via an unspecified route of administration, administered in arm left on13Apr2021 at 01:30 PM (age at vaccination 58 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included diagnosed with type 2 diabetes 3 month after vaccine, nonalcoholic fatty liver since 2005, seasonal allergies, arthritis, and allergic to penicillin & sulfa drugs. Concomitant medications included atorvastatin (ATORVASTATIN); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); montelukast sodium (SINGULAIR); azelastine (AZELASTINE) nasal all taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination. No other vaccine in four weeks. On 14Apr2021 at 01:30 PM the patient experienced Extreme muscular ache & burning, joint pain, chills & nausea, 2 incidents each lasting 4-5 hours, both day after shot. Chills & nausea continued for 35 days until relief came with sinus infection medication. Muscle in arm that took injection aches 3 months later (Jul2021) cannot extend arm outward or upward without cringing in pain. Inflammation like the vaccine flipped a switch triggering reemergence of sciatica & heightened arthritic pain in toes, ankles and fingers. Worst seasonal allergies ever - culminated in acute sinus infection & urinary tract infection from antibiotic. Elevated HA1C not previously an issue (3 month look-back of test overlapped with 3 months post vaccine). The patient visits Doctor or other healthcare professional office/clinic. No treatment was received for the events. No covid was tested post vaccination. The patient underwent lab tests and procedures which included glycosylated haemoglobin: elevated on Not previously an issue (3 month look-back of test overlapped with 3 months post vaccine). Therapeutic measures were taken as a result of nausea. The outcome of the event nausea was recovered 19May2021 and other events not recovered.  No follow-up attempts are needed. No further information is expected.
Pharmacist found expired doses of covid-19 vaccine from previous day in immunization room; shots were removed and placed in a vial in red ink "EXPIRED-DO NOT USE".   vial was placed with used vials of vaccine and diluent for disposal.  Immunizing technician  took this vial and gave two (2) patients shots of this expired vaccine.
Metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste). At the time of the report, DYSGEUSIA (Metallic taste) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Concomitant medication was not reported.  Treatment medication was not reported.
11/13/09 - student complained of headache, stomach ache and occasional cough. Temp. 100.1F
Several headaches and swollen, red, hot, itchy, huge bump since injection (March 26 - today).  Contact physician Friday, April 9, 2021.  She prescribed Medrol dose pack and antihistamine (Benedryl).  Hot and redness subsided.  Now black, itchy patch and severe headaches.
a metallic taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (a metallic taste) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (a metallic taste). At the time of the report, DYSGEUSIA (a metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-368853 (Patient Link).   Reporter did not allow further contact
1 of 5 pts vaxed from the same lot# &who exp an adverse event;pt recvd vax 8JUN95;9JUN c/o inc pain @ normally painful sites (i.e. knee, hip & lower back);pain was treated w/APAP;recovered;
TONGUE SWELLING, SPEECH IMPACTED, RIGHT SIDE FACIAL DROOPING. PATIENT WENT TO EMERGENCY ROOM. EMERGENCY ROOM DOCTOR RULED OUT STROKE. PATIENT DIAGNOSED WITH BELLS PALSY OF RIGHT SIDE OF FACE.
Light headache immediately after and the day following the vaccination. Fatigue set in around 36 hours. I was very tired for the next 24 hours. Also experienced abdominal cramps and loose stools. Around 72-hour mark, throat swelling, difficulty swallowing, extreme fatigue, headache and overall sickness. Went to ER. Doctor said that my lymph nodes were a little swollen but did not suspect anaphylaxis. I was given Maalox, Mylanta, lidocaine viscous and ibuprofen. Now at hour 96 with continued fatigue and headache. I have been sleeping almost 100% of the time.
This spontaneous report as received from a pharmacist via company representative refers to a female patient in her 80's. The patient's drug allergies and pertinent medical history was unspecified. Approximately in November 2014 (reported as about a week ago) the patient was vaccinated with ZOSTAVAX (route, frequency and lot # were not reported). Concomitant medications were unspecified. Approximately in November 2014 (reported as about a week ago) the patient experienced vomiting a few hours after receiving ZOSTAVAX. The outcome of vomiting was unknown. The causality of vomiting was not reported. No product quality complaint was reported for ZOSTAVAX. Additional information has been requested.
Information has been received from a Licensed Vocational Nurse referring to a 4 year old patient of unknown gender. There was no medical history or concurrent condition reported. On 30-JUL-2015 the patient was vaccinated with one dose of (Merck) VARIVAX (dose and frequency were not reported; lot # K005426 with expiration date 15-APR-2016), which was stored in a freezer which had a max temperature excursion of 35.2 (unit unknown) on 16-FEB-2015 (incorrect product storage). The reporter did not know how long this was at this temperature, nor can she be certain if she pressed the right buttons on the fridge to obtain the readings as she did not be trained. The reporter stated that the freezer temperature was 0 Fahrenheit at 8 am and 1 Fahrenheit at 5 pm. The min/max temperature on that day was 0.8/12.2 Fahrenheit (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Chest Pain, Chest Xrays confirmed pneumonia,  Levofloxacin 500mg tablets for 10 days,  Referral to Pulmonary Specialist.,
Vaccine was administered 10/30/2008. Child had a HX of chicken pox documented by MD on 07/18/2007. Vaccine did not need to be administered.
5:00 pm:  Malaise,  Body Aches,    11:30 pm:  Dizziness,  Nausea, Vomiting, Severe Headache Temp/ forehead touch: 99.6.   12 am: Dizzy, Nausea, Headache, Vomiting  T -100.5,    1:00 am:  Same symptoms with T-99,       1:34 am: same symptoms - T-100,  3:00am: same symptoms T-98.5.  6:00 am same symptoms T- 100. Called the doctor and got RX for Zofan,  with good outcome Liquids & Tylenol tolerated  well
had typical side effects  reporting incident due to receiving vaccine less than 90 days after monoclonal antibody treatment
pt complained of dizziness that progressed to headache.  BP taken at 1315 was 184/106, hr 106.  At 1430 bp 183/104 hr 87. o2 97%.  Patient stated that they forgot to take bp meds
taken to ER 10OCT92, fever, photophobia, irritable, sores in mouth, rash face, neck back;
I have a circular redness around the spot of my shot. It looks like a bullseye because it?s almost a yellowy white in the middle. The muscle is also very swollen. It doesn?t hurt though.
Patient said LMP - 2-08 (last Na) x 4 days- Vaccine Gardasil given on 2-08- A couple of days later; mom did home pregnancy test positive x2; child now says she hid doesnt LMP.
Rt arm with some redness & swelling 3 x 4cm no abscess 48 hrs after immunization given.
Information has been received from a mother concerning her 4 year old son who on 29Jul03 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 01Aug03 the pt developed a rash and red eyes. The rash spread throughout the pt's entire body. The pt's mother brought him to the hospital and the nurse stated it was viral exanthem. The pt had shown signs of improvement. The reporter had no other intention of seeking medical treatment. It was reported that the pt had not recovered. Additional information has been requested.
REBOUND COVID(COVID-19); REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 67 year old female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, hypertension, penicillin allergy, and shellfish allergy, and other pre-existing medical conditions included: Patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 077j21-2A expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 10:00 at right arm for covid-19 prophylaxis. Age at time of vaccination 65 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). Concomitant medications included losartan potassium, montelukast, and Hydrochloride(thiamine hydrochloride).  The patient additionally received non-company suspect vaccine Moderna (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, dose was not reported, batch number: 1805025 expiry: UNKNOWN) administered on 01-APR-2022 10:00 at right arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On unspecified date in DEC-2022, patient experienced covid-19 infection(dose number in series 2). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 21-DEC-2022 to 26-DEC-2022 for treatment of COVID-19. On 31-DEC-2022 08:00, the patient experienced rebound covid(covid-19) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable, and with paxlovid was treatment discontinued. The patient was recovering from rebound covid(covid-19), and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Vertigo 7 days after first vaccine. Saw NP after three days. Epley maneuver eased symptoms, and vertigo gradually went away after 10 days from onset. Second vaccine was administered on 2/16/21 (lot 031M20A), and four days later (2/20/2021) vertigo and sinus pressure returned. Visited doctor on 2/25/2021, who advised reporting this as an adverse vaccine reaction. Vertigo is gradually resolving.
Systemic allergic reaction with wheezing and shortness of breath within 15 minutes. Called ambulance when began to get dizzy and confused.  Doctors in the ER said I almost died and had called my parents to warn them that they were not sure if I would make it.
VAQTA was administered three days after it expired.; This spontaneous report has been received from a medical assistant, and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not reported.      On 26-AUG-2020, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 0.5ml, lot # S019435 and expiration date 23-AUG-2020 (route of administration was not provided) for prophylaxis. The vaccine was administered 3 days after it expired. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S 019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sore arm w/in 2 hours. Lasted 24 hrs Fatigue,  w/in 2 hours, lasted  24 hrs Muscle aches, began in 12 hrs, lasted 12 Headache, began in 12 hrs, lasted 6
COVID-19; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000206831.; Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Patient discharged- 2 day hospital inpatient 11/14-11/16/21 HOSPITAL COURSE: Patient is an 81-year-old male who was admitted on 11/14/2021 for acute on chronic hypoxic respiratory failure secondary to bacterial pneumonia and chronic obstructive pulmonary disease exacerbation.   Chronic obstructive pulmonary disease exacerbation Patient was initiated on Solu-Medrol 60 mg q.6, weaned to 40 mg and tomorrow will start prednisone 40 mg daily to then transition back to his baseline 12.5 mg on 11/19.  Continue home inhalers and DuoNebs.   Pneumonia Treated initially with Zosyn, vancomycin, and azithromycin.  I spoke with patient's pulmonologist Dr. who recommended transitioning to Cipro again for 2 week course.  We attempted to get sputum culture but even with Mucinex and saline nebulizers we were unable to get this.  There was no growth to blood cultures.  Patient's baseline O2 requirements are 2 L with activity and sleeping he has been requiring 2 L 247 while here.  Patient feels very ready to leave will have pulmonology and PCP work with him to wean back to his baseline.   COVID-19 positive test Patient's rapid was positive for COVID-19 however thought to be false positive with the late showed a due to COVID-19 infection in September 30th.  Film array was obtained and was negative for any virus.   PT/OT evaluated patient in are recommending home health.  Care Management assisting with this.  Patient's vitals are stable, he subjectively feels well.  Pulmonology team will follow-up in a couple days, patient will see Dr., Cardiology on 11/19.  With a safe discharge plan patient is medically clear for discharge.   CONSULTS / RECOMMENDATION: Pulmonology:  Cipro for 2 weeks, waiting on steroids, they will follow up closely.
PATIENT RECEIVED THE SECOND DOSE OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised, and other pre-existing medical conditions included: The patient took the second dose as patient was immunocompromised and had no known issues after having the second dose. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported, and dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced patient received the second dose of janssen covid-19 vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and patient received the second dose of janssen covid-19 vaccine was not reported. This report was non-serious.
(Per report from technician) "[patient] came in to get vaccinated at 1:20 pm, the vaccine was administered and a few minutes later [patient] started feeling nauseous and her left arm was tingly/numb. I felt her left arm and it was cold to the touch in comparison with the other arm. She was monitored for a full 30 minutes and additionally for another hour post vaccination. We performed a set of vitals and all came out in normal range. I left at 2:50pm, at which time the patient was still experiencing numbness and tingling. [The patient] seemed okay, I also advised her to seek medical attention if it worsens/"