chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse events: Acute pericarditis, right bundle branch block. Diagnosed: after hospitalization at Medical Center emergency department on 11/18/2021. Treatment: 600mg Ibuprofen 3x/day, 0.6mg colchicine 1x/day, metoprolol 1x/day, cardiologist supervision. Outcomes: not yet resolved
Pain, warmth @ inject site, fever, muscle aches, joint pain, malaise, ha/, nausea & diarrhea;
Patient experienced itchy throat and felt slightly wheezy. Patient assisted to ambulance for assessment with normal vitals. Patient felt better and did not need any further intervention.
Patient reports difficulty sleeping that night due to discomfort. Friday afternoon the patient showed her husband the rash which was red and warm to the touch. Friday evening the patient sought medical care at urgent care and was prescribed an antibiotic and MEDROL dose pack. Upon presenting to the pharmacy, the patient showed the pharmacist her upper arm which had a 4-5 inch diameter red, rashy area.
VOMITING; CHILLS; HORRIBLE HEADACHE; NAUSEA; TEMPERATURE 98.9 F; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced horrible headache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced temperature 98.9 f. Laboratory data included: Body temperature (NR: not provided) 98.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, horrible headache, chills, temperature 98.9 f, and vomiting. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
1st dose on 12Dec2022, 2nd will be given on 22Mar2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (On 12th December 2022, received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 12Dec2022, 2nd will be given on 22Mar2023). The outcome of the incomplete course of vaccination 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:22-Mar-2023. No reactions was reported. It was reported that, the 2nd dose was not given prior to the reporting. The reporter did not consent to follow up. Till the time of reporting, patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Delayed onset (approx. 36 hrs) of edema at injection site (approx 6cm diameter) and axillary lymphadenopathy.
Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EWO171) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. The patient didn't received other vaccine in four weeks. The patient didn't received other medications in two weeks. Vaccination history included: BNT162b2 (dose 1, single, lot number: EWO153, vaccine location: Left arm), administration date: 29Apr2021, when the patient was 28-year-old, for Covid-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset Oct2021, outcome "recovering", described as "Bells Palsy". The event "bells palsy" required physician office visit and emergency room visit. Therapeutic measures (Steroids medication) were taken as a result of bell's palsy. The patient visited the urgent care in Oct2021 following sudden loss of feeling/ drooping of right side of face. The patient got diagnosed with Bells Palsy on 09Oct2021 and was still dealing with the fallout/ effects of healing from it. The patient didn't test Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. The patient received the first dose of GARDASIL (lot#, expiration date and dose not reported, intramuscular) on 19-DEC-2014 and administered the second dose of it (lot#, expiration date and dose not reported, intramuscular) on 21-MAY-2015 (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information has been requested.
Systemic: Bell's Palsy-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: wife came to the pharmacy and explained that after the shot the patient had one side weakness went to er and the er stated that the covid shot was the cause of bells palsy severe headaches, and visual changes. she states that it isnt resolving and they are going for more doctors visits
Immunized on 10/17/16. Redness and swelling that evening with discomfort. Progress to lump under skin with the swelling. Warm soaks and TYLENOL for comfort. 10/21 - still complains of itching, cont. to have lump under skin - redness improving.
Left deltoid with erythema, warmth, and pruritus. Treated with Claritin, Topicort cream, and cool compresses.
Client received the 1st dose of Pfizer COVID vaccine lot # EW0179 and expiration date 5/10/21 at 2:39pm.  Client reports to EMT that he feels nauseous and sat down at 2:30pm. Client reports having a history of sinus problems. Client denied getting vitals taken and any interventions offered, ie. crackers & water.  Client left facility unassisted with a steady gait at 3pm.
When returning for next "set" of vaccines, mother, refuses further ROTATEQ, as she believes he had a reaction to the first one. She reports tongue swelling, drooling, and severe abdominal pain with constipation for "a few" days, which then became diarrhea. She denies seeking medical attention for the baby at that time.
Patient screamed high pitched screams for almost 48 hours. There were small breaks where she would pass out from crying but she'd wake back up screaming and crying uncontrollably.
lt arm still swollen w/ 1/2" bump; c/o lt arm itching, has 1" x 1/2" welt next to inject site;
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient received an improperly stored dose of PEDVAXHIB injection (lot # N003536 with expiration date at 02-NOV-2019; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 35.4 degrees Fahrenheit (F) for 12 minutes. There was no previous temperature excursion. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004004.
Wrong vaccine given.  Gave .2mls of undiluted Pfizer Bivalent 5-11 yrs  instead of Moderna 6mos-5yrs
Early in then, I developed a horrible migraine and then experienced uncontrollable vomiting.  I couldn't keep anything down, even water, and became dehydrated.  I was stranded due to a massive ice storm so I spoke to my healthcare professional by phone,  we decided to wait until the 48-hour mark, and then if my symptoms were not improved, I would head to the ER for fluids.  Please note, due to other circumstances, I have never had another vaccine other than the tetanus shot.
It was reported that an anonymous pt was vaccinated "several years ago" with Tetanus and/or Diptheria vaccine. The pt "lost consciousness and developed trouble breathing post vaccination." Medical attention was sought for the experience.
Initial report received from a health care provider on 25-OCT-2005. A cluster of approximately 270 patients experienced a "black dot" at the injection site after receiving intramuscular deltoid injections of FLUZONE from either lot number U1753AA or lot number U1746AA. Attempts to "wipe the black dot off" were not successful. Per the reporter, alcohol swabs are used to prep the vials, and they use BD Precision Glide syringe / needles and regular BD non-safety syringe needles. Approximately 300 doses were administered, now change the needle after drawing up the dose, and the black dot no longer appears at the injectino site. Per the reporter, the status of the event was unknown. Follow-up information received on 16-JUN-2006. Per the reporter, the BD PRecision Glide needles were used to administer other products at the site adn the same result of a "black dot" was observed. Because of th is, the BD Precision Glide needles were changed to another type of needle, and the site no longer saw the black dots. Per the reporter, the event of "black dot" was definitely thought to be associated with the BD Precision Glide needles and not the FLUZONE vaccine. The events of "black dot" were reported as temporary and disappeared later on.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
anaphylaxis to egg; autoimmune disease / never recovered /spiraled; allergic to all the top 8 allergens; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylactic shock due to eggs in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced anaphylactic shock due to eggs (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant) and allergy. On an unknown date, the outcome of the anaphylactic shock due to eggs was unknown and the outcome of the autoimmune disorder and allergy were not recovered/not resolved.   The reporter considered the anaphylactic shock due to eggs, autoimmune disorder and allergy to be possibly related to Flu vaccine.     Additional Information: GSK receipt date: 24-Jan-2023  Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that it did not work for everyone. The patient had received it and autoimmune disease was birth from that moment. The patient also experienced anaphylaxis to egg in the flu shot. The patient immune system never recovered and spiraled. The patient became allergic to all the top eight allergens. The people said how do you know. The patient got shot and went straight to the emergency room. The patient said could no longer get any vaccines.  The reporter think that the event might have been related to the product and device. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Shoulder pain, loss of range of motion almost immediately on administration. Pain disrupting sleep. Better with NSAIDS and rest.
Onset of symptoms started about 15 hours after vaccine administered. Symptoms include fever of 103.5, muscle/joint pain, and headache.
one hour post administer patient reported chills, myalgia, headache, and returned next day with a fever f 100.4 F , fatigue, light sensitivity, chills, sweats, full body myalgia and marked tendernes on site of administeration though no noticeable erythama or swelling on site.
2 weeks after vaccine, patient came back to pharmacy c/o soreness in left arm. He stated he has been unable to left his (L) arm w/o assistance from (R) arm. I called pt a week later to F/U - he said there was some improvement but very minimal. He refused to see an MD.
Patient received second dose in less than 25 days after first dose; Vaccine had been in the refrigerator 33 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose in less than 25 days after first dose) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine had been in the refrigerator 33 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine had been in the refrigerator 33 days). On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose in less than 25 days after first dose). On 21-May-2021, POOR QUALITY PRODUCT ADMINISTERED (Vaccine had been in the refrigerator 33 days) had resolved. On 21-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose in less than 25 days after first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided. No concomitant medications information was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Diarrhea; This is a spontaneous report from a non-contactable healthcare professional (patient).  A 62-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm on 30Dec2020 08:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included asthma, psoriasis, arthritis, overactive bladder, and obesity. The patient also had allergies with penicillin and many non-steroidal anti-inflammatory drugs (NSAIDS). Concomitant medications included etodolac (LODINE), zinc (ZINC), mirabegron (MYRBETRIQ), colecalciferol (VIT D3), ascorbic acid (VIT C), and famotidine (PEPCID). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 30Dec2020 18:00, the patient experienced diarrhea. The patient received bismuth subsalicylate (PEPTO-BISMOL) and loperamide as treatment. The patient was recovering from the event.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Information has been received from a physician concerning an 8 year old male who on 23-JAN-2001 was vaccinated with the first dose of VARIVAX (Merck) (lot # 632366/1458J). On 07-SEP-2008 (also reported as Saturday) the patient started with spots and vesicles appeared. On 08-SEP-2008 the specimen of the patient's lesion hand was sent for culture of varicella. Varicella zoster virus culture results showed that there was no virus isolated. At the time of this report, the outcome was unknown. Additional information is not expected.
While waiting for 15 minutes after the first covid vaccine, patient slumped down the chair but did not hit his head to the floor. Patient was awake the whole time and reported lightheaded as well as dizzy. Pharmacy called 911 and provided a bottle of water while monitoring patient closely. No signs and symptoms of allergic reactions. EMS arrived and checked patient's vitals which were all normal and released patient home with parents.
About a week and a half after my first shot I developed a red rash around my injection site. It was circular and painless, about the size of a quarter. I have had no other issues, but wanted to report this because I was not asked about it on my latest v-safe check in. The rash is disappearing and it was never itchy or painful.
101-102 fever. Severe aches.  Arm red and swollen. Horrible aches fever for 2-1/2 days. Swelling and tired for 8 days.
patient got sick; Initial information was received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient (age unspecified) who got sick (illness), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route  at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (non-serious event) immediately following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.     It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later in the day it seemed as though I had COVID again. Winded very easily, no strength, body aches.
Started with fatigue around 4 hrs after the vaccination. Next was moderate kidney pain which was rapidly followed by all over extreme, intense body aches and joint pain ,fevers and chills, headache and dizziness  all night long. Kidneys continued to hurt for the next 24 hours. Pain at the injection site was SEVERE spreading to the entire shoulder and through my armpit. I could not lift nor move this arm. Sore throat, runny nose, continued fatigue, sore injection site, dizziness and headaches for the 48 hours following the vaccine.
The pt experienced palpitations, irregular heartbeat on 10/13 and 10/14. Seen in ER on 10/13 but symptoms subsided during that time and reoccurred approximately 2 hours later.
Around 3 the following morning. I woke up to an extreme headache and muscle aches in my hips. I tried to go to work that morning but ended up going home due to felling weak like I could pass out. The muscle pain lasted all weekend. The worse pain is the shot location, hips, and knees. I would have hot and cold flashes. Extreme sweating.
On 4-26-08 Patient states that her right upper arm was swollen,red,itchy and warm at the injection site. Area about 3" in diameter. Treated the site with ice and Motrin per patient. The reddened area increased to 7" and she went to the ER on 4-27-08. There she was treated with hydrocortisone cream and Atarax. Went to PCP on 4-28-08 and per patient was given "steroid shot in the hip". Telephone call to patient on 05-07-08. She states that the injection site only has occasional itching, but the swelling is gone. Also said she is having complications to the steroids she received and is still having follow-up with her doctors.
had both shots / shingles /suspected vaccination failure; shingles; pain over my head; pain in right ear; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, headache and ear pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the headache and ear pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, headache and ear pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had both shots and got the shingles really bad. Been almost 2 years ago and still had a lot of pain all over head and right ear. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Hospitalized (9.25.21 - present);  COVID-19 positive (9.16.21);  fully vaccinated  From Admission note:  HISTORY OF PRESENT ILLNESS: Patient is a 73 y.o. female who presents today with CC of dyspnea. Patient states that she and her husband tested positive foir COVID on 9/16. Both are fully vaccinated. Patients husband was very SOB today and EMS was called. EMS found both the husband and the patient were hypoxic and both were transported to hospital.  Other than dyspnea, patient only complaint is fatigue and cough.. PROGRESS NOTE FROM 10/5/21:  Date of admission: 9/25/2021 Date of encounter: 10/05/2021 COVID 19 Pneumonia Acute hypoxic respiratory failure secondary                Patient is vaccinated                Continue dexamethasone to complete 10 days                Completed 5 days of Remdesivir                                Encourage acapella, IS and Proning                Monitor CMP, CRP, D-dimer                Continue to wean oxygen as tolerated                PT/OT Disposition Pending improvement of respiratory status Anticipating pulmonary rehab evaluation or home oxygen need Possible DC in the next 24-48 hours  SUBJECTIVE:  Patient improving slowly however she is very emotional as her husband is now intubated in intensive care unit due to COVID-19
Injectiom sight became sore as the day progressed. Injection sight was extremely sore and sensitive 24 hours later. At 48 hrs the pain had mostly subsided. Awoke the next day (after injection, 1/8)  with a fever of 101° and a headache.  Fever lasted until the evening with some slight body aches. Patient took tylenol and it helped slightly.  Lethargic and took two naps during the day. Day 3 (1/9) all symptoms were gone.