chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional, via a GSK representative and described the occurrence of possible allergic reaction to vaccine in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included TWINRIX; GlaxoSmithKline; unknown given on 29 August 2010; unspecified travel vaccines; manufacturer unspecified; unknown given on 29 August 2010. On 2 September 2010 the subject received 2nd dose of TWINRIX (20 mcg, unknown route and site) on the accelerated schedule. On either 2 or 3 September 2010, less than one week after vaccination with TWINRIX, the subject experienced possible allergic reaction to vaccine, with symptoms of throat tightness, swelling of tongue with pulsating sensation on left side and speech difficulty. The subject required medical attention at the Emergency Room. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The vaccination course with TWINRIX was discontinued.
I had severe body aches , joint pain and headache for about 18 hours - onset was about 4 hours after recieving the 2nd dose of the Pfizer COVID vaccine.
Has not had a period in the 5-6 months since the second dose of vaccine. Had regular, monthly periods prior to vaccine.
Raised itchy rash that feels like a burn and is hot to the touch. Upon research, it looks like covid arm.
Paying co-pay at window, patient became extremely pale, blue lips, catatonic, said, "throat hurts".  Nurse took her back to treatment room where she was laid down, knees elevated, bp checked (extremely low).  Sat up, given Gatorade.  Checked bp x2, color returned to face and lips.  Left building.  Fifteen minutes later returned patient to facility with large, raised, itchy welts/hives extending out from the injection site.  Patient was administered Benadryl and monitored for approximately 45 minutes.  One day after event patient continue to complaining of itching but with reduced hives.
On 1/11/2021, I received the Moderna vaccine and felt extremely fatigued. I went to bed at 7:00 pm and slept until 7:30 am on 1/12/2021. I woke up weak with a fever and chills. My temperature was between 99.4 and 100.7. I also had body aches and loss of appetite.
Within 10 minutes of administering the vaccine, the patient reported numbness in the left arm.  There was no pain or redness, but she reported that her arm felt numb. Advised the patient to take Tylenol or Ibuprofen and contact doctor if symptoms persist for more than 3 days. I called the patient 4 hours later and she reported that the numbness was gone and she was feeling better.
red painful rash on torso and side of hips and legs--rash improved as of 3/29/2021 but not completely gone.  still can see rash
Patient received the Johnson & Johnson vaccine on 8/5/21, on 8/6/21 at noon developed left arm tenderness, fever, chills, night sweats, bilateral lower extremity muscle cramping and heaviness, lack of appetite (lost 15 lbs.), and then one week after the vaccine B/P was 160/120, HR 115, and feels like the left side of the chest/heart is racing.  Leg heaviness has not resolved.
Pfizer-BioNTech COVID-19 Vaccine EUA:  Patient reports dizziness, lightheadedness, and mild skin reaction (redness) at injection site soon after receiving vaccination. No respiratory or gastrointestinal symptoms reported. No loss of consciousness reported.  Initial vital signs: blood pressure 141/72 mmHg, pulse 121 beats per minute, respiratory rate 24 breaths per minute, oxygen saturation 98% on room air. Repeat vital signs a few minutes later: pulse 105 beats per minute, respiratory rate 20 breaths per minute, oxygen saturation 94% on room air. Juice, snack, and ice pack provided. Vaccine administration site cleaned and patient monitored for one hour after vaccine administration and symptoms resolved. Patient left ambulatory in stable condition.
flu symptoms (knocked me flat); flu symptoms (knocked me flat); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: INFLUENZA (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "flu symptoms (knocked me flat)".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling in lower lip, bilateral lower extremity tingling & muscle aches, right forearm with tingling & muscle aches
Within seconds of receiving the FLU vaccine, she felt nausea, and dizziness.  She fainted and fell to the floor. Her eyes were very red and she was incoherent for a few minutes. Breathing was faint. Family member quickly called 911 for an emergency Ambulance assistance. The Ambulance arrived quickly and first responders checked her vitals and her heart. After about 30 minutes we were able to take her home. Today (20 hours later) , she continues to feel unstable, foggy and with headache.
Had heart and chest pains for 3-4 days about a week after vaccine. Pain got even worst when I laid down in bed or was horizontal. No other covid related symptoms
This is a spontaneous report from a contactable consumer who reported for herself. This female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose in the arm on an unspecified date for immunisation. The patient medical history wand concomitant medications were not reported. On an unspecified date, the patient experienced big knot and its turned into like wrap that was going around her arm, allergic symptoms, swelling on the back of the left knee, it was stinging, itching and painful, burning sensation going up the left side of the head. The outcome of the events was unknown.
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a female patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-Hodgkin's lymphoma, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In SEP-2021 (About 3 weeks ago from the date of report), the patient had a blood test which showed no antibodies (Confirmed Immunological vaccine failure). And she also reported that the vaccine gave her nothing but protection. Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210834803. This report was associated with a product quality complaint.; Sender's Comments: 20210945348-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Initial unsolicited report received from a non-healthcare professional on 29 Sep 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone HD (Batch number: UI666AA, expiry date: 13 April 2017, dose, route and site was not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to neomycin. Concomitant medications were not provided. On an unspecified date, post vaccination; the patient developed very high blood pressure and had a stroke. Lab data and corrective treatment was not reported. The outcome of the events was reported as unknown. Upon internal review the company decided to consider the event serious because of important medical event stroke. List of documents held by sender: none. Sender's Comments: Patient had stroke and high blood pressure following Fluzone HD vaccine. This is poorly documented case as time to onset is unknown and additionally information regarding patient medical history, any medication history considering the patient age as she may be hypertensive, past vaccination history and its tolerance are needed to further assess the case.
Narrative:  Patient was not previously COVID-19 positive and did not have any  predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient past medical history include DM1-II, Heart Failure, CAD, Osteoarthritis, A. Fibrillation, Hypoxemia Respiratory Failure, Heart Block. Per note on March 10th 20212, patient returned for ACA following hospitalization for fluid retention and cellulitis. No other relevant notes were find and also Pt was 78 years old.
pt experienced blurred vision with dark spots and chest tightness Rph gave 1 diphenhydramine 25mg pt went home with husband
On antibiotics after first dose, on steroids after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (On antibiotics after first dose, on steroids after first dose) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (On antibiotics after first dose, on steroids after first dose). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (On antibiotics after first dose, on steroids after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  The reporter was taking a course of steroids and antibiotic Amoxicillin after first dose. She was supposed to get second dose of Moderna COVID-19 vaccine and wanted to know if there are any drug interactions.
FELT THE NEEDLE WENT CIRCULAR IN ARM; This spontaneous report received from a consumer concerned an male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (Dose number in series 1) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown), dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 23-DEC-2021 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 23-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s the patient felt the needle went circular in arm and the patient also mentioned he had never felt that before (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt the needle went circular in arm was unknown. This report was non-serious.
11/21/21 presents to ED for "with right side pain". PMHx of "CKD and hypertension"
Pt exp GBS secondary to flu vax given 8OCT93; since the vax pt had exp 2-3 wks of upper body discomfort & weakness;
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Gardasil give in Right Deltoid on Monday March 26. On Wed, March 28, patient reported itching, swelling and redness in Right upper arm. 4 1/2 inch by 5 inch red, swollen, hot area noted on upper right arm. Taken to see MD on Thursday March 29. Patient started on Omnicef 300mg BID, Zyrtec 10mg QD, cool compresses and Advil PRN. On Saturday, March 31, Patient becan complaints of tingling in fingers of Rt. hand. Rt. arm 3-4 cm larger than left arm. Called Dr. instructed to elavate arm and give Advil around the clock. Report increase swelling or symptoms to physician.
Fever up 103 noted 2 days p/vax - associated w/episode of vomiting & diarrhea & decreased appetite. MD visit on 5FEB91, temp still up to 105. Temp elevated intermittently through to 7FEB91, responded to Acetaminophen & tepid baths.
BLOOD IN URINE; ABDOMINAL PAIN; ACUTE,SHARP STOMACH PAIN; INDIGESTION; ARM SORENESS; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and other pre-existing medical conditions included had no medical history except back surgery in 1999 and no concurrent medications. no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced arm soreness. On 02-APR-2021, the subject experienced blood in urine. On 02-APR-2021, the subject experienced abdominal pain. On 02-APR-2021, the subject experienced acute, sharp stomach pain. On 02-APR-2021, the subject experienced indigestion. On 13-APR-2021, Laboratory data included: CT scan (NR: not provided) results came back clear., and Prostate examination (NR: not provided) results came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, chills, and fatigue, had not recovered from blood in urine, abdominal pain, and acute, sharp stomach pain, and the outcome of indigestion was not reported. This report was non-serious.
all list adverse reactions were experienced: fatigue,  muscular aches, headaches, fever and chills, profuse sweats, extreme shortness of breath...all of which sent me into fib and high blood pressure.
Red circular rash at infection site (approximately 2 weeks after injection) Breast tenderness  day after (lasted two weeks relief once menstral cycle started) Swollen lymph node in armpit and groin area on side of injection (left side) started day after injection and still present  Fatigue since injection Back ache since injection
Vaccination failure; + COVID Ag; HA; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 28 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2589) at the age of 28 years as dose 3 (booster), single, administration date 11Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20Mar2021 (Lot number: EP6955) 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: VACCINATION FAILURE (medically significant) with onset 23Mar2022, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 23Mar2022, outcome "unknown", described as "+ COVID Ag"; HEADACHE (non-serious) with onset 23Mar2022, outcome "unknown", described as "HA"; FATIGUE (non-serious) with onset 23Mar2022, outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Mar2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, headache, fatigue.  Clinical course: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown and unknown diagnosed with COVID-19 Prior to vaccination. Device Date: 23Mar2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE)  headache and fatigue cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Abdominal cramps, headache, fatigue, minor body aches, minor chest aches during sleep, trouble sleeping.
Dx: atypical measles, fever, rash symptoms. TX: Reassurance. Will return.
Patient complains of tenderness and inflammation of left upper arm since PNEUMOVAX on 4/18/12. Complains of tenderness to touch only. Swollen arm. Sulfamethoxazole/trimethoprim 1 tab BID, diphenhydramine 25 mg once
Lightheadedness, weakness, runny nose, congestion, HA, muscle aches. States, "almost did not go to work following day- but at work" reporting symptoms.
Patient received Moderna COVID vaccine on 6/2/21 and 6/30/21. On 1/11/22, patient admitted to our inpatient med/surg unit with acute hypoxemic respiratory failure due to COVID-19 pneumonia and AKI. Patient discharged home on 1/14/22 with 2L oxygen. Patient was re-admitted again later that day with upper GI bleed (thought to be possibly secondary to NSAID induced gastroduodenal ulcer) and discharged home on 1/16/22.  Patient has been on 2 L oxygen on discharge last admission and was able to be weaned off of oxygen during the 2nd hospitalization.  No complications from COVID-19 infection noted during 2nd hospitalization.
felt lightheaded and a "little off" after doing errands at lunch about 2 hours after taking vaccine. BP was 190/110 while at work and was sent to the ER. BP there was 209/125. Was given Nifedipine CR 30 mg at 17:49. Discharged from ER with primary care follow up on 12/21. BP 4 months prior to vaccination was recorded at 168/110 at office visit.
Pruritus immediately following DTaP/IPV that became increasingly severe, followed by erythema of upper arm and edema over 24 hours.  Cool compresses and benadryl improved swelling and itching, but 72 hours later, arm still erythematous but with less edema.
Fever Chills Joint pain Headache,  injection site (left arm) red, swollen and sore Stomach pain
Vaccine 6/26/07. Body rash for 7 days. Day 7 - fever, nausea, abdominal pain. Day 6 - transient confusion, seen in emergency room.
Child was quite behind on vaccinations after missing several appointments with our office. Came in with mom, VIS statements given and screening checklist completed. Mom denied any illness, client was noted to have rosy cheeks, appearance similar to rosacea, he has fair skin and mom reports as sensitive skin. Child received vaccinations, he did cry pretty hard during the process as one would expect. He was consoled quickly after the injections were complete. Several minutes after the injections checked on client, he was drinking a bottle and interacting appropriately, normal behavior. At that time it was noted he had small petechiae on his face. Noted on forehead, eye lids and cheeks. None noted anywhere else on his body. We questioned if this was related to the crying during the procedure. We watched the child for the full 15 minutes and maybe a bit longer, no change in rash, no signs of other reaction. Mom was instructed to keep an eye on him and to bring to ED if any changes. Once the child had left we discussed case with each other and decided it would be best to let the Immunization program chief and the child's PCP know about the event in case it was a reaction to one of the vaccines. Mother was made aware we would be contacting the PCP, at the time of this call she reports child is behaving normally and no change or worsening of rash. PCP called and he did decide to order bloodwork, CBC. When called mother to let her know about the order she was resistant to bring the child in for bloodwork that night. She was encouraged by this nurse to call the PCP to discuss risk versus benefits of that decision. PCP also called by this nurse and made aware of mother's response, at that point transfer of care to PCP.
Pain and swelling at injection site (left arm), dry mouth, thirst, joint pain, lower back and right leg shooting pain
swelling and pain at location of a previous broken left clavicle the break occurred in 1986, and was healed naturally, no surgery Pain still exists 3 days after vaccine no other reactions
Patient was having shortness of breath and turning blue so parents took him to ER and was admitted to ICU.  11/13/09 DS received for DOS 10/20/09  10/22/09 Final DX: Respiratory viral syndrome.    The Pt was admitted to the hospital on 10/20/09 with a HX of acute life threatening event including cyanosis, shallow breathing, chest pain, neck soreness and headache. Pt received flumist H1N1 vaccine the previous day.  That night Pt had poor appetite, fever and cough. Pt had few bradycardia episodes of 45-50 bpm.  Pt was placed on telemetry and was stable. Rapid DFA test was negative, but sensitivity was ~ 50%, so Tamiflu was started.  Viral culture for influenza was pending.  Pt's physician considered viral illness possibly influenza exacerbating the Pt's underlying cardiopulmonary status. Also, Pt's physician considered that Flumist is a relative contraindication to use in asthma, although Pt did not have any sx of asthma in years. Pt was discharged home in stable condition.