chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an expired dose of Daptacel; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a physician by phone.   This case involves a 24 months old patient (gender not reported) who was vaccinated with an expired 0.5 ml fourth dose of  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5169AA and expiry date: 16-Mar-2019) in the left thigh on 09-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
mom states child woke next am after recieving vaccine with sore leg and redness at site. states gradually got bigger. about the size half dollar. advised to alternate warm and cold compress and to tx with advil or motrin and benadryl as needed. if worsens to seek md care.
sore muscles in both arms; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) and MYALGIA (sore muscles in both arms) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm) and MYALGIA (sore muscles in both arms). At the time of the report, VACCINATION SITE REACTION (Covid arm) had resolved and MYALGIA (sore muscles in both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-365147 (Patient Link).
Patient woke up the next day with raised, itchy rash all over body except on face, chest and upper trunk.  Took OTC medicines and rash lasted 3 weeks.  Reported to PMD and called today 6/2/09 for Lot number and Manufacturer.  Patient has history of allergic reactions to many things but she attributes the rash to Influenza Vaccine received on 12/9/08.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
UTI; bladder infection; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient reported that she may have a UTI or bladder infection. She wanted to know if she can take nystatin. She got the first shot and will be getting the second shot and she doesn't want to mess it up. She also wanted to know if she can get the antibiotic after the 2nd shot. She stated she also read about immunosuppressants. The outcome of the events was unknown.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Fever; Chills; Muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (Dose 1), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.   On 31-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Oct-2022, received fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 06-May-2023, received sixth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient started with the 4th Covid-19 dose the patient switched to Moderna Covid-19 vaccine because her doctor thought that it was better and with less side effects. The patient had a reaction of a fever, chills, muscle aches, and fatigue for 48 hours. After second Moderna Covid-19 vaccine had a reaction of a fever, chills, muscle aches, and fatigue for 48 hours. After third Moderna Covid-19 vaccine the patient had a reaction of a fever, chills, muscle aches, and fatigue for 48 hours.   This case was linked to US-MODERNATX, INC.-MOD-2023-747054.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747054:Same Patient (SPIKEVAX 2023-2024 case)
NO AE REPORTED, HOWEVER WAS ADMINISTERED IM INSTEAD OF SQ. PER BAVARIAN NORDIC, NO REPEAT DOSE IS REQUIRED
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 27-JAN-2016, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-AUG-2016, the patient was treated at an eye center facility for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. (It was not reported if the patient was treated by the ophthalmologist or another health care professional at the eye center facility.) As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
1/4 inch welt pt noticed below skin 1/2 inch under tattoo on her left deltoid arm.
Immediate pain at injection site when med was pushed in. Fever, sever muscle and joint pain, congestion, fatigue, stomach ache.
about a week after the injection, a raised red area developed just below the injection site, first about 2 inches in diameter. About 4 days later, it grew down the arm towards the elbow totally about 4.5 inches wide and 7 inches in length
Severe arm pain, still cannot lift/use arm at all. Lethargic on Saturday, day after injection. Nausea on Monday
At 2pm felt arm was hurting a lot at injection site. Pain worsen to the point that couldn't move the arm. It was hurting like if someone had hit the arm with a baseball bat; he couldn't pick up anything. Patient called after-hours nurse who instructed use of ice and TYLENOL. Treatment helped a little bit. The next day, still felt pain but not as severe; could bend arm again. Patient felt very dizzy, weak, and had heart palpitationslike if he was coming down with something. Patient did not take any other medication and he not have a fever. Called nurse who recommended to continue to move arm even if it hurts--up and downand continue with ice and TYELNOL as needed. By night the level of pain was tolerable, area of injection was sore at touch, felt weak and dizzy so it hard to get on wheelchair. Today arm feels a lot better, it is sore at injection site, has more motion, no pain when moving arm, still feels tired and dizzy. Patient did not take medication today, but continues to use ice packs. At the beginning the pain level was 10/10 and now at 0/10 or 8/10 when touched. Nurse comes daily to home for foot ulcer care.
Feverish arm; Arm started being sore; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm started being sore/ pain in extremity, feverish/ feeling hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events arm started being sore, feverish.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm started being sore, feverish was not resolved.
Seizures within hours after receiving immunizations lasting 10-40 seconds each. Associated with being lifted or moved from one position to another. Patient stiffens and eyes roll back. Per 60 day follow up: pt has not recovered. Pt is having these seizures every 3-4 weeks and they last 4 days. i know it is caused from the vaccine. This definately needs to be reported. All test are coming back normal so it all points to injection thats causing these episodes.
Swelling of right right leg from below the knee to my toes caused me to go to the doctor which concluded that I had a DVT in my right leg
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 23-SEP-2014. Demographic details for each patient were provided. This report referred to a 6-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 14-JAN-2014 after noon (also reported as 27-FEB-2014). It was reported that this dose was spoiled since the refrigerator was too cold. The parents of the patient were going to talk with physician and declined to repeat the dose. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Took vaccine, still got shingles/suspected vaccination failure; shingles/Took vaccine, still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that she personally knew 4 other people who took vaccine and still got shingles. The reporter stated that the vaccine was expensive and did not work. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:Same reporter US-GLAXOSMITHKLINE-US2022AMR105921:Same reporter US-GSK-US2022AMR111697:Same reporter US-GSK-US2022AMR111696:Same reporter US-GSK-US2022AMR111699:Same reporter US-GSK-US2022AMR111700:Same reporter
Dizziness, Headache, Myalgia, Fever, sore left arm Narrative:
I got vaccinated on April 8 at approximately 9:00 am. After 12 hours strong body pain began, headache, fever, chills, nausea, diarrhea, fatigue... also the area of the vaccine today April 12 still red, inflamed and a little hot.
On 11/21/21 facial swelling and redness started to appear. Was more noticeable on right side of face. No trouble breathing was noted. Benadryl was given and swelling decreased, but did not completely go away. On 11/22/21 my daughter woke up to have her whole face swollen, but again was more swollen in the right side. Her right eye was  almost completely shut. No breathing issues were noted.  Again benadryl was given and pediatrician was contacted. During clinic visit it was recommended to continue benadryl  every 6 hours for 24 hours and  monitor, and if breathing issues developed we were encouraged to seek emergency care. After return from doctors visit, small rash was noted to right inner forearm area.
Itching, pain, swollen, redness on injections area. Pt. taking ibuprofen and applying ice to affected area. Pt. had a fever yesterday.
Pharmacy tech who was given a dose of MMR due to recent Mumps outbreak.  She reports no previous history of adverse reactions to the vaccine but about 40 minutes after the vaccine she started itching in the palms.  She reports being itchy and having blotchy skin and feeling warm.  She started to drive and then she started having shortness of breath and feeling tight in the throat.  She also reports some stomach cramps and reported to the allergy clinic.  No recent ingestion of foods.  No other medications.
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the regulatory authority and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
During the administration of the Fluarix vaccine, the needle was faulty and the vaccine spilled out of the syringe where the needle attached to the syringe. Not sure if patient received any of the dose. Vaccine was the readministered with a new Fluarix vaccine with no issues.
p/vax pt fell, hit back of head, exp sz, LOC, combative, taken to hosp;sustained skull fx, cerebral hematoma, contrecoups injury, cardiac arrest, rt craniotomy;cond improved, d/c from hosp in early OCT;trouble walking, vision & hearing prob
Prolonged seizures with fever less than 24 hours after administration of Dtap, MMR, Varicella, Hepatits A and Pneumococcal conjugate vaccines. Required multiple anticonvulsants and endotracheal intubation with transfer to PICU for further care.  03/20/2008 MR received including WCC of 3/5/08 and ER visit 3/6/08 and subsequent F/U. Child transported to ER in status epilepticus x 35 minutes.  Temp 102.0 on arrival, actively seizing with mucus at mouth, (+) pallor, rhonchorous respirations.  Pt intubated and txd with phenobarbital, ativan, and fosphenytoin.  Transfered to higher level of care. 5/20/2008 D/C Summary received for DOS 3/6-14/2008 with D/C DX:  Atypical Febrile Seizures.  Extubated on 3/8/08 with post-extubation stridor and sx of bronchiolitis with respiratory distress.  Improvement noted with pulmonary tx and solumedrol. Seen in ER again 3/15/08 and 3/16/08 for fever, emesis and diarrhea. DX: AGE. Follow-up: Doing well at follow-up on new seizure medication.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose# 01/07/2021.pfizer Lot#EL3248 2nd dose:.01/28/2021 pfizerLot#EL9262 Diagnosed covid positive: 03/03/2021 Exposure: Community Symptoms: Asymptomatic
Akathisia; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 10Apr2021 at 09:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had known allergies to penicillin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 20Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Apr2021 at 00:00, the patient experienced akathisia. No therapeutic measures were taken as a result of reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event akathisia was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Global urticaria, still ongoing to this date, the rash will come and go on all parts of my body, it is painful and itchy
feeling hot; flu-like symptoms; weight gain; tiredness; glaucoma; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GLAUCOMA (glaucoma) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. In February 2021, the patient experienced GLAUCOMA (glaucoma) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING HOT (feeling hot), INFLUENZA LIKE ILLNESS (flu-like symptoms), WEIGHT INCREASED (weight gain) and FATIGUE (tiredness). At the time of the report, GLAUCOMA (glaucoma), FEELING HOT (feeling hot) and WEIGHT INCREASED (weight gain) was resolving and INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In Feb 2021 patient was diagnosed with glaucoma. She was feeling flu like symptoms and tired. In the last few months as of 19 Mar 2021 she had been feeling very hot and gained some weight. It was unknown if she was enrolled in a COVID 19 vaccine trial. Patient received 1st dose COVID 19 vaccine manufactured by Moderna.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was vaccinated with the high dose flu vaccine when she was supposed to receive the regular dose vaccine.  Pt was vaccinated by a licensed APRN. Patient was immediately made aware of the vaccine administration error. Pt verbalized understanding.
Itching and swelling of mouth, throat, and injection site. Runny most. Tightness in chest. Heat, swelling, itching, redness (large wheal) at injection site, about 4-5 inches in diameter that persisted about 10 days.
Patient currently hospitalized at (12) days admission. This is a 23 y/o female with a PMH of morbid obesity BMI 57, OSA, asthma, hx of extreme premature birth with tracheostomy x 1 year as newborn who presents with a CC of shortness of breath. On interview, pt is wearing bipap. Bipap was removed and pt was placed on 3L O2. pt has significant stridor and wheeze on exam. She is able to answer all questions but is a limited historian. She is reporting associated cough. She denies fever, chills, productive cough, diarrhea, or trouble swallowing.  She is joined at bedside by her mother who states the pt has had stridor like symptoms mostly while latying flat for the last few months. She states she has been seen by her PCP and urgent care a few times over the last month and treated with steroids, antibiotics, duonebs and inhalers with short but temporary improvement. She confirms the pt is fully vaccinated and boosted with covid 19 vaccine. In the ER the pt was found to be afebrile with HR 130, RR 29, BP 143/82, and was placed on bipap. CBC with WBC 15.9, Hgb 11.3, otherwise WNL. VBG with pH 7.46. , procal WNL. CMP with glucose 120, ALP 137, otherwise WNL. viral CPR positive for covid 19. CXR showed new low lung volumes with bibasilar airspace opacities suspicios for atelectasis vs PNA vs aspiration. Hcg negative. The pt was given solumedrol, albuterol, duoneb, racemic epinephrine and admitted for workup.
I was really Tired My arms swell up; and I also broke out in hives for two days. I  took Benadryl and rested until the symptoms when away. Did call and talk too a nurse.