chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was just I was going to see my GP for a well check in June 2022. My blood pressure had been sort of high the last few times I went to see the doctor but this time it was very high at like 181/128. Dr. then prescribed another medication. I'm scheduled for an echocardiogram on Thursday. She diagnosed me with high blood pressure.
Developed break down in hives in different part of body.Describes hives in back area which crawl back to chin area. Itching in armpit; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed break down in hives in different part of body.Describes hives in back area which crawl back to chin area.) and PRURITUS (Itching in armpit) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Developed break down in hives in different part of body.Describes hives in back area which crawl back to chin area.) and PRURITUS (Itching in armpit). At the time of the report, URTICARIA (Developed break down in hives in different part of body.Describes hives in back area which crawl back to chin area.) and PRURITUS (Itching in armpit) had not resolved.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-439650, MOD-2022-439506 (Patient Link).
Developed headache and fever, temp max 103.8 the evening after having been vaccinated in the am. Temp down to 100 by the next am, headache resolved. No long-term effect. Temperature just seems high for a vaccine reaction.
Patient came to ED with worsening shortness of breath.  Patient was admitted to the hospital with acute exacerbation of COPD, pneumonia, and Covid.  Patient treated with remdesivir.
HCP reports the patient did not experience any side effects.; HCP called in to report that a 6 month old infant was administered GARDASIL 9 on 08/15/2022.; This spontaneous report as received from a registered nurse refers to a 6-month-old male patient.  Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 15-AUG-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe for prophylaxis (lot number: U032681, expiration date: 26-OCT-2023; dose, anatomical location, and route of administration not provided) (product administered to patient of inappropriate age). The patient did not experience any side effects (no adverse event).
I do not know if the vaccine had any effect on what occurred, but thought it was worth reporting.  I got vaccinated (first dose) a week after my period. I got pregnant that cycle-my first pregnancy. My due date would have been November 13, 2021. At week 5, shortly after I discovered I was pregnant, I began bleeding slightly. At the hospital, after taking an ultrasound they diagnosed me with an angular pregnancy--in other words, the embryo had implanted on the very edge of the uterus. I was advised that this put me at high risk of early miscarriage. I didn't miscarry, and the pregnancy seemed to be going normally for some weeks. At week 15, however, an early anatomy scan revealed severe IUGR-the baby was measuring two weeks behind. Further investigation revealed that the cause was a placenta that seemed never to have formed correctly. By week 25, we were told that the baby was dying, would not survive delivery at that birth weight, and that continuing the pregnancy  was putting me at high risk of complications. Based on this, we chose a medical abortion at 26 weeks. I delivered stillborn; the baby weighed 380 grams, a weight appropriate to 21 weeks.  Doctors do not know exactly what caused the IUGR. But as I tested negative for blood clotting disorders, they said the likeliest culprit is the angular pregnancy. I was also scanned to see if there were any anomalies in my uterine shape to make me more prone to poor embryo implantation, and the test came back normal. Given that I was vaccinated only a week or two before implantation would have occurred, I thought it was at least worth considering if there was a connection.  I was vaccinated in another country. I only received one dose of the vaccine, as I had recovered from  COVID in March 2020 (I had a mild case, with no lingering symptoms). Per the country's vaccination policy, people who have recovered only receive a single dose.
Seven days post vax, pt broke out with a light case of varicella, confirmed at clinic visit 4/17/2000.
Pt reports on evening of 1/22/20 he developed a rash and warm feeling on Right upper arm. Pt said this was noticed when doing triceps exercise at the gym. Pt covered area with band-aide approximately 3 cm diameter. Pt returned to Health Department for PPD reading L  fore arm  (which was negative). Reddened warm to touch skin noted about the diameter of the entire right posterior arm. Redness most deep in area of band-aide. No c/o pain. C/) slight itch.
right thumb is numb; soreness in the injection stie; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (right thumb is numb) and VACCINATION SITE PAIN (soreness in the injection stie) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN (DIOVAN), AMLODIPINE and EPLERENONE for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HYPOAESTHESIA (right thumb is numb) and VACCINATION SITE PAIN (soreness in the injection stie). At the time of the report, HYPOAESTHESIA (right thumb is numb) and VACCINATION SITE PAIN (soreness in the injection stie) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Scleral hemorrhaging of the right eye. Bleeding covered about 1/3 of visible sclera. This occurred after the first Moderna vaccination as well as the 2nd.
Third covid booster; Third covid booster; COVID-19; COVID-19; Vaccination site swelling; Vaccination site induration; Vaccination site pruritus; This is a solicited report from a contactable consumer (patient), via the non Pfizer-sponsored program, and based on the information received by Pfizer. (MFR. Control no. 21K-163-4076974-00).  Solicited report from a consumer of a 62-year-old male with events of non-serious COVID and patient had swelling, hardness and itchiness around injection site after third COVID booster with adalimumab (HUMIRA). There was no reported medical history. In 2021, the patient experienced patient had swelling, hardness and itchiness around injection site after third COVID booster. In Aug2021, the patient experienced COVID. In 2021, the COVID and patient had swelling, hardness and itchiness around injection site after third COVID booster resolved. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 28Dec2020, patient received first dose COVID-19 vaccine manufactured by Pfizer. On 19Jan2021, patient received second dose COVID-19 vaccine manufactured by Pfizer.  Causality for adalimumab (HUMIRA) The reporter's causality for the event(s) of COVID with adalimumab (HUMIRA) was no reasonable possibility. The reporter's causality for the event(s) of patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021, patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021 and patient had swelling, hardness and itchiness around injection site after third covid booster onset in 2021 was not provided.  Change History: On 11Oct2021, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "patient had swelling, hardness and itchiness around injection site after third covid booster" was added.  The reporter's assessment of the causal relationship of the reported events with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - COVID-19, vaccination failure, vaccination site swelling, vaccination site induration, vaccination site induration, immunization, off label use and the suspect drug "BNT162B2" cannot be completely excluded.
8 days after vaccine right arm is still very sore with swelling and there is a defined red area that is 4cm diameter that is warm to touch
This spontaneous report as received from a healthcare worker via a company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with doses of GARDASIL (dose, dose number, route, lot # not reported). On an unknown date the unspecified number of patients came into the office approximately one year later to continue their GARDASIL series. No adverse symptoms reported. The outcome of event was unknown. Additional information has been requested.
not reconstituted with the supplied diluent / possibly reconstituted with sterile water; patient received a dose of Hiberix that was not reconstituted with the supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 4925E, expiry date 24th October 2021) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that an unknown patient received a dose of Hiberix that was not reconstituted with the supplied diluent on unknown date, which led to wrong solution used in drug reconstitution and administration of inappropriate dose of vaccine. The incorrect dose was possibly reconstituted with sterile water. The reporter stated that they have narrowed it down to 4 patients but they were unsure which one patient received the incorrectly reconstituted dose. No further information reported. The reporter consented to follow up. This is 1 of the 4 linked cases, reported by same reporter. Note: All the linked cases were conservatively kept valid as the reporter was unsure which patient received the incorrectly reconstituted dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073596:same reporter US-GLAXOSMITHKLINE-US2021073386:same reporter US-GLAXOSMITHKLINE-US2021AMR073597:same reporter
Presented to ED complaining of increased weakness for 5 days; Workup in the ED show he is positive for Covid 19; tx w/abx, steroids, zinc; dc'd home w/HHC.
The day of the shot My entire arm was very sore and hot, it was very intense, the next day it was better. Though upper arm does hurt sometimes still. I have shoulder pain every since the vaccine and it comes and goes.
Adacel which expired on 21JUL2019 and was given today, 02AUG2019 to an 11 year old female; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old female patient who received 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5729AA and Exp. Date 21-Jul-2019) via unknown route in unknown administration site, on 02-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was reported that Adacel which expired on 21-Jul-2019 and was given today, 02-Aug-2019 to an 11 year old female.   It was unknown whether the patients had any adverse reactions.  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.  List of documents held by sender: none.
Awoken the next morning with bilateral eyes edema and right blurred vision.  Improved over the course of 90min.  Blurred vision resolved within 90 min.  Bilateral periorbital edema persists at 11:30AM but improving.  Prescribed Medrol dose pack.  Suggested cold compress and benadryl.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced unspecified injection site reactions after an injection of SHINGRIX. The patient had denied permission to contact their physician. The pharmacist did not wish to participate in the safety report. This pharmacist said that her patient reported it via a Vaccine Adverse Event Reporting System (VAERS) but did not provide any further details and did not wish to be contacted. The patient wanted to be answered by Medical Information (MI). This case was not previously reported to anyone.
Headache, Myalgia & Fever Narrative: As reported by Employee 6/24/2021: ***************************************** "12/23/20 I received 1st dose I had very bad headache, Body ache and slight fever for a day"
Persistent headaches following  first dose of Moderna COVID-19 Vaccine, with no relief.
fever 106 x 1/2 hr dec temp 104 p/2 hrs;
Approx 5-10 mins after vaccine, pt c/o of weakness, lightheaded, pounding headache, color pale, hands trembling, BP 128/80, 134/94, 160//80.  Benadryl given, 911 called. Developed rash and hives at hospital, tx for allergic react to vax.
Mother calls stating child's arm is red and swollen from shoulder to elbow and states MD informed her immunization has administrated inaccurately.  Resulting in infection to area for which he prescribed antibiotics.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 80 hours (Lowest recorded temperature was 30 F (-1.111111111 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); 168 hours (Highest 49 F (9.444444444 Celsius); 24 hours (Highest recorded temperature was 48 F (8.888888889 Celsius), 416 hours (Highest recorded temperature was 47 F (8.333333333 Celsius) and 336 hours (Highest recorded temperature was 59 F (15 Celsius). No product quality complaint was involved. Additional information has been requested.
After I received the vaccine, during my 15 wait period, I started to sweat and feel like I was going to pass out about 3-5 min after getting the shot. I called for help and the pharmacist called EMTs who checked me out. After about 45 minutes, I felt better and requested to leave and NOT be transported to a local hospital.
Half an hour after I was vaccinated my right arm was very sore and I develop a bump near the injection site. After I went home about 2 hours after the injection I had these bumps going down my arms on both arms. I was tired so I went to sleep. When I woke up I had more of those red bumps on my arms. I took Ibuprofen. About 3 days later that started to clear out and about a week later it was fully gone. About the first week of February, I woke up with red rash all over my body, chest, belly button, belly, neck etc. and my legs only have those red bumps and they have developed more and more. I went to an APPT and my doctor said it was an yeast infection. Its started to get itchy and my doctor prescribed an ointment (CLOTRIMAZOLE CREAM USP 1%) to put on the rash. It looks like the ointment is started to work, I have to recovered from the rash but the ointment is working slowly.
Patient experienced fatigue, muscle aches, nausea, erythema and swelling at LT deltoid. At office visit to address reaction, doctor advised cold compress to area of swelling, ondansetron as needed for nausea, Ibuprofen 600mg every 8 hours as needed.
Patient came in 10/4/19 along w/ her husband for a yearly fLu shot. All immunization protocols were followed by pharmacist - patient was fine when she left. Sat afternoon patient came in to show me her arm where shot was given - it was ReD, Warm to touch (per patient) a bit swollen and the rash radiated from injection site down past her elbow. patient stated she had applied ice to the area to minimize the reaction. She was going to pick up some Benadry and try a low dose of Ibuprofen to calm the adverse reaction. I instructed her to check back in with me Monday to see how she feels and to Assess the reaction. (1) Spoke to patient on 10/10/19 (finally heard back) and she said reaction has calMeD Down - barely noticeable in (L) arM and she is feeling just fine.
BLOOD CLOT IN LEG; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received ibrutinib (tablet, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, 1 in total 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 an unspecified date, the patient experienced blood clot in leg, and was hospitalized (date unspecified) for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibrutinib was not reported. The outcome of blood clot in leg was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0. 20210507935-covid-19 vaccine ad26.cov2.s -blood clot in leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The patient presented to the ER after having the vaccine several hours earlier in the day complaining of chills, shortness of breath, chest tightness, abnormal jaw movements and twitching of his eyelids with uncontrollable movements of his eyes as well.
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.; Total duration of the excursion refrigerated temps for max of 4 hrs.; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. It was reported that total duration of the excursion refrigerated temperature for maximum of 4 hour. On 01-Dec-2021 Vial was moved to fridge. State of the vaccine at the time of excursion was partially thawed/liquid.   This case was linked to MOD-2022-496015 (Patient Link).
Redness and swelling around injection site. Some hardness & pain. Resolved in ~3 days
Patient  received the first dose of Pfizer BioNTech Covid 19 Vaccine (LOT# EW0162, exp. 7/2021) at 1327. At 1335, patient reported needing to vomit to EMT.  MT gave patient emesis bag. Patient vomited in emesis bag and immediately stated she vomited due to anxiety. Patient reported stated she felt completely fine after vomiting. Patient refused assessment and treatment. EMT gave patient water and and an extra emesis bag. Patient advised to wait for further observation. Patient waited for 10 minutes. At 1445, patient stated she wanted to leave. At approximately 1446, patient was accompanied by her mother and left facility with unlabored breathing and steady gait.
I have eye inflammation; both eyes. The optometrist prescribed Lotemax 4 times a day for the inflammation. I have my second shot in a week and would like to know if it's safe to get it.
patient received approximately .3 of bivalent moderna instead of the correct dose of 0.5 ml dose.