chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received full dose Moderna instead of Pfizer Booster.  Called pt 11/12 and pt reports no adverse effects after Moderna dose beyond some arm soreness.  Per the patient, the arm soreness was as he would have expected for any vaccination.
Patient received ZOSTAVAX 9/26/12. She came to pharmacy 9/28/12 w/ 2 inch oval, raised, red reaction - itchy, painful. I called primary MD who started her on KEFLEX 500mg PO BID for cellulitis & diphenhydramine 25mg x 1 empiric dosing. Patient responding well 9/29/12.
Severe reaction in allergic symptoms that include chronic and excruciating headaches, aches, high fever, fatigueness, and swelling to soreness where shot was given. Is currently being treated for these symptoms. Pain in right arm. Information received from the 60 day follow-up states not fully recovered have improved in symptoms still do have headaches and pain in arm. Information received from the annual follow up indicates patient has not recovered. My headaches worsened, I have migraines on a daily bases & pain so I am not sure if the shot caused me to have pain with neurological symptoms such as pain on arm and legs-numbness etc. I really don't know if the shot caused my headaches to worsen because every since I took the shot in a months time, I expereinced more pain that is chronic. Or altogehter this could be mistaken.
swollen lymph nodes; facial swelling; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18Feb2021 at 14:00 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine, the patient was no diagnosed with COVID-19. Concomitant medications included cetirizine (ZYRTEC) from an unspecified date for an unspecified indication. The patient previously received naproxen from an unspecified date for an unspecified indication and experienced allergy. The patient also had allergies to beeswax, honey, chemical aerosol sprays, and perfumes. On 18Feb2021 at 16:45, approximately three hours after the vaccine, the patient experienced facial swelling and swollen lymph nodes. The events were reported as non-serious. The patient went to the emergency room/department of urgent care as a result of the event and received treatment with high dose diphenhydramine (BENADRYL). The outcome of facial swelling and swollen lymph nodes was recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Medical Assistant administered adult dose bivalent booster to patient.  Pt had a local reaction at injection site and was reevaluated on 3/10/23.   Mom informed of adult dose error at time of vaccination.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # M033086 with expiration date 05-MAY-2018, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009011: US-009507513-1707USA009012: US-009507513-1707USA009013: US-009507513-1707USA009014:
81 y/o male patient was vaccinated 3/3/21 and died 3/6/21. Patient's wife reported he was having "some trouble breathing" but could not remember whether this problem started before or after being vaccinated.
I had vertigo and had one syncope episodes. My symptoms continue and I am being worked up for a number of possibilities. I am still receiving treatment for my syncope. CT scan of the head, carotid ultrasound and a number of lab tests were performed.
administered Havrix to an 8 month old pt; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. In May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case was reported by medical assistant. The reporter stated that last month another employee administered Havrix to an 8 month old patient instead of to a 2 year old patient. The reporter did not have additional details at time of call. The reporter consented to follow up via email. Additional Supportive Information: The reporter stated that 8 month old patient was administered Havrix instead of to a 2 year old patient which led to inappropriate age at vaccine administration.
12 hours after shot  cold feet/body  pain at injection site  aggressive shakes/shivers normally associated with fever for 1.5 hours awoke in am very very tired/lethargic/no appetite for whole day. awoke second day feeling fine.
pt recv vax; devel rash and greater than 50 lesions over body,over 20 at inject site;
Piercing debilitating headache, body aches, severe chills, vomiting (couldn?t even keep down water), nausea, diarrhea, severe exhaustion, abdominal pain, and I got my period one week after having it!!!!!!
In May 2021 I had more difficulty breathing than normal. I had surgery the year before on polyps in my nose. Then my breathing got so bad I had to use a nebulizer and my doctor prescribed medication for that. I started using my albuterol more. My doctor switched me to a different inhaler, and it did nothing more. I was referred to a pulmonologist. The pulmonologist switched my inhaler and it worked for a while. Then I started having more trouble again. The pulmonologist recommended I go on a biologic medicine which has not been approved by insurance yet. I was diagnosed with eosinophilic asthma.
NO SYMPTOMS OR PAIN AFTER FIRST SHOT (MODERNA 027A21A 3/5/21) EXCEPT FOR SORE ARM. HOWEVER, 48 HOURS AFTER 2ND  INJECTION (MODERNA 027B21A% 04/02/21), BOTH KNEES STARTING HURTING. DIFFICULTY WALKING AND SLEEPING. TO DATE 6/11/21, (69 DAYS) PAIN CONTINUES. SOME OSTEOARTHRITIS HAS BEEN DETECTED IN BOTH KNEES (6/10/21). THEORY IS THAT THE 2ND VACCINE OVERSTIMULATED IMMUNE RESPONSE AND HAS CAUSED ARTHRITIS FLARE UP IN BOTH KNEES. NOTHING HAS RELIEVED PAIN TO DATE.
Woke up to a large red itchy swollen shoulder the size of my palm, it's been 2 days and not changed.
not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling well".  Additional information: The patient would like to ask for assistance to schedule an appointment for the second dose of the vaccine since he had problems with his internet. He received his first dose last 26Feb2021 and was supposed to return to the facility on 19Mar2021 but he was unable to because he is not feeling well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Area on (R) arm 4cm x 3cm, occurred day after received the pneumonia vaccination (4/29/16), and has persisted since despite unsuccessful treatment at home. Pt reports slightly warm to the touch, slightly sore to the touch. Has cont. redness since injection. Treatment: Cont. BENADRYL 25mg Q 6 hours PRN itching, prescribed prednisone 10mg x3 days, if symptoms worsen, need to be re-examined.
broke out in a 103.5 fever the next day.; I have had a very bad headache all day long; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) in the right arm on 18Mar2021 at 12:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, the patient broke out in a 103.5 (units unspecified) (body temperature) fever and also had a very bad headache all day long. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of fever and headache (unspecified). The clinical outcome of the events fever and headache was unknown at the time of this report.   No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
(2) doses of varicella given. One at 16 months and other at 4 yrs of age. Patient developed shingles on 3-5-15 at 5 yrs 8 months. Wound cx positive for varicella zoster.
pt recvd vax;25jul95 exp fever; 26jul95 exp blood streaked stool; to md ofc;
Hives; Itching all over; Entire body was red; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewoln6) via an unspecified route of administration in the right arm on 14May2021 at 12:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT) for unspecified indication from unknown date. The patient had no known allergies to medications, food or other products. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccine. 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 14May2021 at 14:00, 2 hours after vaccine, the patient experienced hives, itching all over and entire body was red. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives, itching all over and entire body was red were recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
swollen and some discomfort Left lymph nodes neck/above collar bone.  By day 2  evening, it had increased in size so it was very visible by others compared to the right side, which is why I am submitting report. Extended down neck to collarbone. Tender to touch and some discomfort turning neck.  Right side neck lymph nodes very slightly swollen, no discomfort. sore arm on 7/21 improving by 7/22. slightly sore to. touch on 7/23. Fatigue on 7/21
PER PATIENT, SHE EXPERIENCED HEADACHE AND HIGH BLOOD PRESSURE (182/85) AFTER 2 WEEKS FOR GETTING HER JANSSEN COVID 19 VACCINE. SHE SAW DR. FOR THESE SYMPTOMS. EVENTUALLY HER BLOOD PRESSUE CAME BACK TO BASELINE WITH CHANGE ON HER BLOOD PRESSURE THERAPY REGIMEN. MD WAS NOT SURE IF IT IS RELATED TO VACCINE
Today, she noticed that she has dizzy head.; Even right now when she is sitting down, her hip feels funny.; She also has nausea.; Her vocal cord was tight; Within 1st 24 hours, she had a sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Her vocal cord was tight), DIZZINESS (Today, she noticed that she has dizzy head.), PARAESTHESIA (Even right now when she is sitting down, her hip feels funny.), VACCINATION SITE PAIN (Within 1st 24 hours, she had a sore left arm) and NAUSEA (She also has nausea.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced THROAT TIGHTNESS (Her vocal cord was tight) and VACCINATION SITE PAIN (Within 1st 24 hours, she had a sore left arm). On 23-Jul-2021, the patient experienced DIZZINESS (Today, she noticed that she has dizzy head.), PARAESTHESIA (Even right now when she is sitting down, her hip feels funny.) and NAUSEA (She also has nausea.). At the time of the report, THROAT TIGHTNESS (Her vocal cord was tight), DIZZINESS (Today, she noticed that she has dizzy head.), PARAESTHESIA (Even right now when she is sitting down, her hip feels funny.), VACCINATION SITE PAIN (Within 1st 24 hours, she had a sore left arm) and NAUSEA (She also has nausea.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Eye drops for glaucoma.  Treatment information was not provided by the reporter.
The afternoon of receiving vaccines the patient had a slight temperature and was fussy with no appetite and possible nausea. Patient developed a solid, red band across forehead from ear to ear slightly involving the eyes. The band came and went for 1 day. The next day the patient was whiney and lethargic but was fine after that. The patient was seen on 2/22/01 for vomiting and diarrhea. Patient was seen in the ED on 2/23/01 with vomiting, diarrhea and red facial rash and was diagnosed with gastroenteritis.
Particulates were found in the prefilled syringe for Prevnar 20/ Prevnar 20- syringe has particulate in the syringe and patient was unable to get vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EJ4559, Expiration Date: Jun2023) for immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2607, Expiration Date: 31Aug2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PHYSICAL ISSUE (non-serious), described as "Particulates were found in the prefilled syringe for Prevnar 20/ Prevnar 20- syringe has particulate in the syringe and patient was unable to get vaccine".  Additional information: Medical assistant requesting stability information on a temperature excursion for Prevnar 13 that went above temperature range for around 30 minutes. Caller was unsure of specific temperature vaccine had reached. First excursion. Unknown if patients received Prenvar 13 and Prevnar 20 after 30 minute lapse in temperature. Reporter confirmed he does not know the temperature reached. Reporter later added in regards to Prevnar 20 it looks like something separate in the the mixture. There were particulates in the prefilled syringe. He shook it like it says too and he still sees the particle. When probed if any patients received the Prevnar 20 with this particulate, initially stated none that he knows of. Later added, he saw it when getting ready to give to a patient. He looked at a couple more of them and saw they all had them. He told the patient he did not feel comfortable to give the vaccine today. They all came from the same lot. He caught it before giving to a patient and this one was not given.
Patient has complained of a sore arm since the vaccine. Nothing topically but hurts to raise arm or move in any direction upward. He is interested if this has occurred with anyone else. Condition are still persisting today.
Fully vaccinated, not boosted.   Asymptomatic COVID infection breakthrough with inpatient hospital stay.
August 12 an expired dose of Twinrix was administered for a patient's first dose in the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 12-AUG-2023, the patient received the 1st dose of Twinrix. On 12-AUG-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: August 12 an expired dose of Twinrix was administered for a patient's first dose in the series). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 14th August 2023: Pharmacist stated that an expired dose of Twinrix was administered for a patient's first dose in the series. The reporter did not consent to follow-up. The reporter did not have more information and declined follow-up. The patient received an expired dose of Twinrix which led to expired vaccine used.
Needle came apart and vaccine dripped down the arm; Patient got less than half the dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Needle came apart and vaccine dripped down the arm) and INCORRECT DOSE ADMINISTERED (Patient got less than half the 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Needle came apart and vaccine dripped down the arm) and INCORRECT DOSE ADMINISTERED (Patient got less than half the dose). Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: No specific follow-up information recorded.
Large hot sore red patch at injection site, bruising, soreness, fatigue, low grade fever
Pt complained of difficulty breathing, generalized hives, mild SOB, Rsp-24, facial swelling, redness, hives, decreased lung bases. Upper arms, trunk and thighs with wheals erythmatous. Mild anaphylaxis. Epigen and epinephrine, Benadryl given and transported to hospital and monitored for 6 hours.
Sore arm the first night.  8 days in I got what I believe is COVID arm.  The injection site was warm, red, swollen, and felt like a big knot or lump.  Fatigue, back pain.  On day 13 I also got a rash on the inside of my arm, on the bicep area.  It was red, bumpy, and slightly itchy.  I missed some work due to fatigue.
Several days after vaccine patient came in and said he had trouble breathing, his chest was tight, maybe had a fever, and his blood disease (adrenal gland disease) was acting up within 24 hours of having vaccine. He was not sure if he wanted to get the 2nd shot.
Experienced significant persistent coughing in parking lot during 15 minute observation.  Honked her horn and was evaluated by medics, who determined that she should be transported to hospital.   Patient indicated a history of allergic reactions, and later indicated that she had previously needed to use an EpiPen. Treated at hospital with epinephrine which resolved the coughing.
One day post vax, the pt's left arm became red and sore at injection site. The pt had a fever of 101, and then was taken to the doctor on 3/22/00. A diagnosis of cellulitis was made. The pt was place on an antibiotic. Arm is better and fever is down.
4/26/2017: large vesicular-like lesions on proximal aspect BUES extensor surface with multiple erythematous satellite papules, similar lesions on proximal aspect BLES, no drainage or discharge noted. Start BACTROBAN cream 2% 3 times a day 10 days. 4/28/2017: rash BUES and BLES, lesions more extensive. 5/9/2017: generalized papular rash scabbed over.
Sore throat, cold symptoms. Positive Binax test. Prescribed Paxlovid, symptoms resolved, Binax test negative 5 days later. Symptoms recurred 03/24/2022 and iHealth test positive on that date. Symps persist and still have positive.Condition is mild
Within 5 minutes of vaccine patient felt tachycardic, HR was 143 BPM and she also felt dizzy. She was hydrated and observed for extra time and her HR was 97 BPM. She claimed this was common when she's anxious.
This spontaneous report as received from a nurse refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-MAR-2016, while the patient's 4 year old child was receiving a dose of PROQUAD (Merck) injection (dose, lot# and expiration date were not reported), the vaccine splashed an unspecified way into the patient's right eye. The patient was seen by a physician on the same day for an eye exposure with PROQUAD (Merck). The patient experienced no adverse effects following the eye exposure. The reporter confirmed that the patient's child received a full dose of PROQUAD (Merck). Additional information has been requested.
Local pain and swelling within 24 hours. Fever to 102.3 degrees F. Admitted to hospital 48 hours after vaccination for IV antibiotics.
This spontaneous report as received from a pharmacist via a field representative refers to a male patient of unknown age. The patient's medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial (subcutaneously, dose, lot# and expiration were not provided) for shingles prevention. On an unknown date, the patient experienced a blister-like rash at the injection site. It was not specified if any treatment was given. The outcome of the blister-like rash at the injection site was not reported. Causality assessment between the blister-like rash at the injection site and the ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish to be contacted.