chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     Additional Information: GSK receipt date: 27-Apr-2022 Reporter's comment: The case was reported by patient's friend. The patient received a dose of Shingrix and had experienced redness at the injection site. Gave medical disclaimer.  Referred to health care professional.  Spoken as per package insert and content.  Provided medical information phone number for health care professional reference. Did not consent to follow-up. Additional supportive information: The case was linked with case US2022070815, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070815:Same reporter
2 adjuvant alone was mixed; adjuvant only administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number B2C9F, expiry date 11th February 2024) for prophylaxis.   On 14th November 2022, the patient received Shingrix. On 14th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 14 NOV 2022 Reporter's comment: The reporter stated that the patient received 2 Shingrix adjuvant alone was mixed and administered to the one patient. The vaccine administration facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: As the patient received 2 Shingrix adjuvant alone, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Itchy rash developed on chest and upper stomach soon after vaccinated. Mostly gone by morning
shot #1 on 17-Nov-2020 but has not yet received Shingrix shot #2.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix received on 17th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: The reporter was wife of the patient. The age at the vaccination was not applicable for this report. Till now patient didn't receive his second dose which led to incomplete course of vaccination. The reporter reported husband was not there to give consent however wife indicated that she does not think her husband would mind that she gave GlaxoSmithKline his doctor's contact information. Consented to follow up. This case is linked to the case US2021000076, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000076:Same reporter
No additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 17-MAR-2022, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) dose 0.5 milliliter (lot# U029147 verified as valid with expiration date: 16-MAR-2023) (dose number, frequency, route of administration and anatomical location were not provided) for prophylaxis. The aforementioned vaccine underwent a temperature excursion of 9 degrees Fahrenheit for 1 hour and 25 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
two year old male patient was inadvertently administered QUADRACEL, no AE; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two years old male patient who inadvertently received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 09-Feb-2021, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5772AA and expiry date: 17-Sep-2022) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error inappropriate age at vaccine administration (latency on same day).  Reporter relationship: health care professional (HCP) Product used: used  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
syncope likely w/ carpal spasm approx. 10 minutes following administration, 30 seconds duration; r/o seizure
Temperature of 105 per mother's report, following the administration of the DTaP, IPV, Hib, PCV-7, and rotavirus vaccines.  Also had temp of 103 after 2 month vaccinations, but thought to be within normal limits.  Fever resolved in a day per mother.
This spontaneous report as received from a medical assistant via a company representative refers to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately May 2015, (reported as one year ago), the patient was vaccinated with the first dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported). Then, on an unknown date (reported as a couple of months ago), the patient was re-vaccinated with the second dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported). The patient did not report any extraneous symptoms due to revaccination. The patient did not seek medical attention and no treatment was given for the adverse event. Additional information is not expected as the physician did not wish to be contacted.
Chills, sweats, massive headache, no sleep, pain/soreness at injection site
Fever; highest recorded digitally on head 101.1; oral high 100.9.
Has not taken any dose after taking first dose of Vivotif; Spontaneous report received on 13FEB2020.  A physician assistant reported that a male consumer who "has not taken any dose after taking first dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif for immunisation. On 07FEB2020, the consumer took first dose of Vivotif. He took his second dose out of the fridge but fell asleep before taking the dose and did not take his second dose on 09FEB2020. The consumer had discarded his second dose on Monday, 10FEB2020. The reporter stated that the consumer had not taken any doses after his first one. Action taken with Vivoitf with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer has not taken any dose after taking first dose of Vivotif (Missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.; Sender's Comments: A consumer has not taken any dose after taking first dose of Vivotif (Missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.
lymph node swelling left armpit, lymph node swelling left neck/lower jaw area; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: En6205) via an unspecified route of administration administered in left arm on 04Mar2021 at 14:15 as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included high blood pressure, high cholesterol, heart disease, and asthma; all from unspecified date. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced pain at injection site on 05Mar2021 (next day), lymph node swelling left armpit which started 08Mar2021, and lymph node swelling left neck/lower jaw area which started on 13Mar2021, all non-serious. Adverse event treatment included acetaminophen and ice. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
site red, sore & swollen 9.5cm x 5.5cm @ 48hr, 99.4 fever;afeb 11APR96 tenderness dec redness inc to 13.3cm x 6cm;
Patient became hypertensive and was experiencing right scapular pain. Hypertension did not resolve with rest. Patient was sent to emergency room via ambulance for further evaluation
A 47-year-old female patient was  in the observation area after administering her first dose of Pfizer to her left arm. The patient tells to the EMT that if she can verify the pressure because she is hypertensive.
About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She reported "having waves of dizziness" that "made me feel like she was going to pass out but was clearly not" also reported "dizzy spots" in her vision. She had 3 separate episodes, each lasting about 4-5 minutes each. BP @ onset 100/63,  pulse 57, after resolution, 100/62, pulse 62. O2 sat 100%. All symptoms resolved after a total of 30 minutes post vaccination.
Spiked a 100. + fever Sunday night. Fever broke with sweating at about 3:00am.  No fever today, just a bit weaker than usual.
24 hours after receiving the COVID booster (3rd dose), patient experienced chest pain and tightness, shortness of breath, and lightheadedness.
RMA retrieved MMRV instead of MMR out of the Accu Vax machine. Patient received Varicella and MMRV on June 11, 2019 at hiss WCC visit.
Had the vaccine, got a bad case of shingles, Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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-DEC-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The reporter reported that his/her sister-in-law had the vaccine and still got a bad case of shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available. This is 1 of 4 link cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR193098:Same reporter US-GSK-US2022AMR193110:Same reporter US-GSK-US2022AMR193112:Same reporter
03/20/2021: Patient presented and was admitted through the ED for generalized weakness that started 3 days after he received his Covid vaccine. He stated that since 3/10/21 (date of covid vaccine) he has been unable to ambulate.  Although he complained of generalized weakness he admits that his legs cannot care for him and he also has upper extremity weakness.  Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
patient's care giver reports that patient is talking non sense and behaving like panic. no other symptoms reported. Patient is administered vaccine on 05/10/21 and showing symptoms on 05/11/21. Care giver is advised to contact primary care doctor and take Tylenol if any fever or pain.
Pt states she began to experience chills/nausea 3/25 evening which then subsided by the next morning. States that she awoke 3/27/11 with noticeable localized redness, minimal localized swelling and warmth below the injection site. Pt evlauated today- advised to continue with ibuprofen, cool compresses and Benadryl prn. To c/b if symptoms persist, worsen.
Fever 103, decreased feeding, not rolling over; seen in clinic 2/13/17 and had normal exam; fever again overnight and had some clear rhinorrhea and slight throat clearing and seen in clinic 2/14/17 with normal exam other than slight increase in previously noted rash on side of mouth; parent reported fever again 2/15/17 and decreased responsiveness and poor feeding-indicated parent preference to have further evaluation elsewhere.
Patient had high anxiety about getting shot. Received  shot with no problem but was highly anxious after shot and just thinking about the event caused her to have seizure. She was out for only approx. 30 sec. Called 911 and EMTs came. checked vitals all were fine. Decided seizure was from anxiety not from shot itself. Patient had orange juice, waited a while then refused to go to hospital. she left, we checked on her later, she was fine
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history was provided. On an unspecified date in May 2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot # L037560 with expiry date: 29-SEP-2017) and a dose of M-M-R II injection (lot # L027431 with expiry date: 22-JUL-2017; strength, dose, route and site of administration were unspecified for both). The administered vaccine underwent the temperature excursion at 50 degrees Fahrenheit for 3.5 hours. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Recieved 2nd does on 3-13.   Got hives on 3-15 and everyday since then they are getting worse.  Went to my doc and he put me on steroids for 12 days.  This is helping, but I will start weaning down on the Prendisone and will see what happens
fever pain, redness  and swelling at injection site muscle aches nausea. Patient stated symptom stated 3 hours after receiving vaccine and lasted for 3 days Patient stated she took naproxen for fever and pain
Patient reports he received his first FLUMIST vaccine in OCT 2009 while deployed. (Immunization records shows patient received IM flu vaccine in OCT 2009, but patient recalls lining up and getting the FLUMIST). Within hours of vaccine receipt, he developed rhinorrhea, cough, stuffy nose, upper airway congestion, headache (pressure-type pain above and behind eyes), sneezing, watery eyes, fever up to 100+ degrees F, chills, swollen glands in his neck and on the 2nd or 3rd day after vaccine receipt, he developed diarrhea (4-5 watery stools, no blood, no cramping, no N/V). He also reports muscle soreness in his chest and upper abdomen from coughing. He denies any facial swelling, redness of eyes, sore throat, sinus pressure or drainage, rashes, wheezing or dyspnea. Following his initial FLUMIST, patient was admitted to the hospital on bedrest for 2 days. He received IV fluids and he is not sure what other medications he received. (There are no encounters in the system addressing this admission). Although he was discharged from the hospital and RTD, patient reports his symptoms gradually improved over the next 2 weeks. Patient reports a similar reaction following his 2nd FLUMIST vaccine received on 17 OCT 2010. He was not admitted, but he was on bedrest at home x 1 week (48 hours quarters, work supervisor permitted him to stay home an additional 2 days, and then sick over week-end). Again, his symptoms gradually resolved after 2 weeks. He was instructed to take ALEVE and increase his fluid intake. Patient experienced similar symptoms within 24 hours of FLUMIST vaccine receipt again in SEP 2011, but less severe and not requiring time off from work or bed rest. This year, on 14 AUG, patient received the FLUMIST vaccine and developed similar symptoms (no diarrhea) which only lasted about 24-48 hours. However, on 15 AUG, patient was seen in the ER for irritated, red eyes and was diagnosed with severe Dry Eye Syndrome. (Patient reports he has had Dry Eye Syndrome since 2006 after PRK. He denies anything different about symptoms on 15 AUG, other than severity). Patient reports always feeling well on day of vaccinations, prior to vaccine receipt. He denies history of recent infection prior to vaccine receipt. With each reaction, the FLUMIST was the only vaccine received on that day, with no other vaccines received in the past 30 days. He does not recall any potential exposures prior to vaccine receipt. He denies allergies to medications, foods, latex and insect bites/bee stings. He denies a history of seasonal allergies.
Muscle aches, fever, nausea, fatigue, erythema , swelling , pain at injection site.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. Initial information was processed along with the additional information received on 16-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: spondyloarthropathy (seronegative), and allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 042A21 A, and expiry: unknown) dose was not reported, 1 in total was administered on 01-APR-2021 for covid-19 prophylaxis. The patient received additional booster dose non-company suspect vaccine Pfizer BioNtech covid-19 vaccine (tozinameran) (dose number in series 2), (suspension for injection, route of admin not reported, and batch number: 3203080, expiry: unknown) dose was not reported, administered on 25-OCT-2021 for covid-19 prophylaxis. Concomitant medications included ascorbic acid, famotidine, macrogol, melatonin, and omeprazole. The patient was treated with Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 24-MAY-2022 to 28-MAY-2022 for treatment of COVID-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On 31-MAY-2022, the patient experienced a rebound Covid infection after taking Paxlovid, and tested positive again 03-JUN-2022 (confimed covid-19 infection) (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1).  On 03-JUN-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, Pfizer BioNtech covid-19 vaccine (tozinameran) was not applicable and with paxlovid was drug discontinued. The patient recovered from confirmed covid-19 infection on JUN-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000246582.; Sender's Comments: V0: 20220832201-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
pt brought in by mom recvd MMR lt deltoid remained sitting for 1 1/2min got up to the doorway fell (poss passed out) fell to the floor; pt was alert BP 108.74, pulse 90, discharged to home w/mom;
pt recvd vax 31DEC93 & w/in 3 hrs exp recurrence of wheezing, paleness, & difficulty in breathing
This was my Moderna booster shot. It?s hard to read lot number as it was hand written.   I had breast implants put in 4 weeks ago. I got the booster yesterday morning. By 8 pm my breasts became swollen, inflamed, and the right breast had three solid  pink circles. The circles have gone but I still have a lot of pain and inflammation I in my breasts, especially the opposite breast if the injection site. I have not been able to get to a doctor yet.
I was tired the first night. The next day every single muscle and joint in my muscle ached  all night and all the next day. Even my skin hurts. I also have a headache, nausea, and I ran a fever of 101.7° all day. I was shivering in addition to having night sweats
About 3 days later woke up with my neck and upper shoulder feeling intense pain about 8/10 and lack of mobility of my neck to turn to the left
ADMINISTER PFIZER 0.3ML FIRST DOSE VACCINE PER PROTOCOL, AFTER ADMINISTRATION PATIENT EXPERIENCE SHORTNESS OF BREATH, CHEST PAIN, SWELLING IN HER ARMS. ADMINISTER EPIPEN RIGHT AWAY AND CALL 911. EMT ARRIVED AT SCENE TOOK VITALS AND MONITOR PATIENT. EMT STATES PATIENT WAS STABLE ENOUGH TO GO HOME. PATIENT LEFT WITH HUSBAND.
I sat down for 15 min and felt fine for the rest of the day. The hives started about 30 mins after I had dinner. It started on my shoulders and back, so I took a Benadryl, which was expired. So, I went to get some more and took a second dose around midnight. I won't up with none, but they were back around noon. That happened for a few days with it happening around lunch and dinner. On Tues, they started spreading more, so I went to the doctor. There was no swelling of the tongue. They lessened over the next couple of days. As of today, I have a small amount of itching, but nothing bad. I've also been taking Claritin since yesterday. I have not seen any the same size as before, but I notice that they seem to be worse at night. I took my BP a few times and it was high at those times, but it went back to normal the next day. I will be seeing an allergist in the near future.
Narrative: 59 yo male patient reported symptoms starting on 8/5/2021 and includes subjective fevers, chills, fatigue and myalgias, cough productive of sputum, loss of taste, sinus congestion and unsteady gait. Patient tested positive for COVID on 8/11/21 although was previously fully vaccinated with Pfizer on 1/28/21 and 2/18/21. Patient with CRS grade of 1 and continues to remain on room air.