chrisvoncsefalvay/vaers-outcomes huggingface dataset:
booster; Developed edema in her ankles and legs; Skin flushing; Feeling off balance; Developed rash over whole body; Seemed to develop rapid heartbeat 10-30 minutes after injection; illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021US003088.  A 77 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 77 years as dose number unknown (booster), single for covid-19 immunisation; abaloparatide (TYMLOS), subcutaneous since 18Jun2021 (ongoing) (Batch/Lot number: unknown) at 80 ug daily for senile osteoporosis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (2nd dose, Unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; OEDEMA PERIPHERAL (non-serious) with onset May2021, outcome "unknown", described as "Developed edema in her ankles and legs"; FLUSHING (non-serious) with onset May2021, outcome "unknown", described as "Skin flushing"; BALANCE DISORDER (non-serious) with onset May2021, outcome "unknown", described as "Feeling off balance"; RASH (non-serious) with onset May2021, outcome "unknown", described as "Developed rash over whole body"; HEART RATE INCREASED (non-serious) with onset May2021, outcome "unknown", described as "Seemed to develop rapid heartbeat 10-30 minutes after injection"; ILLNESS (non-serious) with onset May2021, outcome "unknown", described as "illness". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for abaloparatide was dosage not changed. Additional Information: The patient experienced rash (start date first month, duration two weeks); heart rate increase (start date first month ,duration 30 minutes); oedema peripheral (start date second month); flushing and balance disorder. Treatment information was not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Dizziness and vomit a few times but only mucus. BP was 140 and drop down to 102 the next day
Received a 3rd dose; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient recently received a 3rd dose of the vaccine by accident, which led to extra dose administered.  The reporter asked if there was any information on 3 doses. Follow-up would not be possible as no contact details available.
p/vax mom noted rash on childs face, trunk, & back;child seen & noted to have generalized maculopapular eruption to cheeks, trunk & back;no tx given;
The pt experienced left arm redness, swelling 48 hours post vax. Treated with cool compresses, Advil and Benadryl.
Tremors/weakness x3 wks. Dizziness x2 wks.
Diarrhea, headache, fatigue, violent chills, insomnia, high fever, weakness
Patient stated the arm became red and very sore the day after injection. She came in 2 days later to show me and it was red and warm to the touch about the size of a golf ball. Patient is taking ibuprofen and icing this seems to have  helped with the symptoms. If they persist or does not get better she will go to her PCP.
Extreme difficulty breathing, high blood pressure, bronchial congestion treatments include prednisone, VENTOLIN HFA.
got the shot then got the shingles / Suspected Vaccination Failure; shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shingles shot and ended up getting the shingles a few months later. The porter asked so much for that shot and requested no more shots of any kind for him or her. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
On 12-23-2020, I developed symptoms of  sinus congestion along with a cough, fever, body aches and a tightness sensation in my chest. I got tested for Covid on 12-27-2020 and was positive. I also had diarrhea and nausea.  I did telemedicine with my primary healthcare doctor and I discussed with him that I felt tightness with pressure sensation to my chest and he said that it was cause of my asthma and he told me to take prednisone medication.
8/24/21  The patient called the pharmacy. She indicated that she had a red streak on top of her shoulder going towards her armpit. She also had some pain extending towards her her shoulder blade and part of her neck. I advised her to seek medical attention from a physician that day. She said she informed the physician that she recalls that I sanitized the injection area very well before administering the injection. On 8/24/21 at 8:37pm an electronic prescription for Cephalexin 500mg was received at the pharmacy. I called and informed the patient. The patient arrived 8/24/21 around 8:55pm and picked up the prescription. She said the physician asked her to purchase Benadryl over the counter.  8/26/21 the patient said she was feeling better.
COVID-19 BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative via social media (Facebook) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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, 1 total, administered on 22-Mar-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 breakthrough infection and had suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 breakthrough infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210910687-covid-19 vaccine ad26.cov2.s-Covid-19 breakthrough infection. 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). 20210910687-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
sick; nausea; vomiting; inflammation; have not been able to work; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, on an unspecified date in 2021, the patient was sick with nausea, vomiting and inflammation uncontrolled to the point patient had not been able to work. Patient's doctors could not find anything in the tests they had ran, and they were saying it was from the vaccine. They was reporting several patients with the same symptoms that appeared after getting the 2nd dose. Outcome of all events were unknown.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Following day fever (102.7) chills, exhaustion, weakness, achy, body pain soreness, head ache, redness swelling extending 4 in diameter aroung injection site
On the night of the shot, I had a low fever and moderate fatigue. Since the day of the shot, I have had pain in my right shoulder, radiating to my neck, side of the face , around the right eye socket and some blurring of vision to the right eye.  Three days after the shot, I had numbness in my upper legs for a couple of days. I could walk but not feel them. I still have reoccurring pain in my right shoulder and eye,
Patient was administered with vaccine that had undergone temperature excursion.; No adverse event; Patient was administered with vaccine that had undergone temperature excursion. This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion.) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis. No Medical History information was reported. On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that had undergone temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that had undergone temperature excursion.). Concomitant medications were not provided by the reporter. It was reported that, the duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were still frozen after the excursion.  No symptoms were reported after the administration of the vaccines. Vials were unpunctured at the time of excursion.  Lot numbers affected were  AS1412B and AR5186C with expiry date of 10-Feb-2023 and 17-Nov-2022. It was determined even though there was a temperature excursion one time that the vaccines were still viable and can be used until the end of the day on 17-Aug-2022. Treatment information was not provided. This case was linked to MODERNATX, INC.-MOD-2022-628685 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2022: Significant follow up received included patient information, dosage information and narrative updated. Sender's Comments:  MODERNATX, INC.-MOD-2022-628685:Master case.
syncopal episode following injection - return to baseline after laying down with feet up and having juice/snack.
Initial information has been received through the Merck Pregnancy Registry for GARDASIL from a registered nurse concerning a 20 year old female with a penicillin allergy and attention deficit/hypersensitivity disorder who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL (LOT# 660387/1967U). There was no concomitant therapy. Subsequently, she became pregnant. On 06-AUG-2008, an ultrasound was performed with the result "looks okay". The date of her last menstrual period was 01-MAY-2008 and the estimated delivery date is 14-FEB-2009. The patient's outcome was unknown. The patient called the physician's office. Follow-up information has been received from a registered nurse to report the pregnancy outcome. On 15-JAN-2009 the patient delivered a normal, healthy male baby weighing 6 pounds 13 ounces. The baby's length was 19.5 inches and head circumference was 13.5 inches with unsure apgar score. There were no congenital anomalies. The baby wouldn't suck. He was placed in neonatal intensive care unit (NICU) and received tube feeding for 8 days. During pregnancy, there was no complication, infection and illness for the patient. The patient took prenatal vitamins daily. There was also no complication during labor/delivery. Additional information is not expected.
red rash, about 2 inches circular at injection site started about 10 days after injection.  almost gone after 5 days.
Information has been received from a consumer concerning her daughter, a 14 year old female who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL, 0.5 mL, intramuscular, The caller stated that when her daughter received the first dose of vaccination she was 2 months pregnant. On 14-OCT-2008, the patient received the second dose of GARDASIL. Caller did not mention any adverse event. It was unknown if the patient sought medical attention. Additional information has been received from a consumer concerning her daughter, who "delivered really early and the baby died after it was born." The consumer stated her daughter was almost five and a half to six months pregnant and she started having pains in her side, went to the doctor and was told everything was ok and went home. The next week her pains started again and then felt like contractions, and when she went to the doctor she was already dilated around four or more centimeters and they couldn't stop her contractions. The consumer reported that the baby was born and then died (No further details provided). It was reported that the consumer's daughter had good days and bad days. The baby's experience is reported in WAES 0810USA02499B1. Upon internal review, preterm delivery was determined to be an other important medical event. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA  Site pain, nausea, fatigue, feeling unwell, headache
pt recvd vax & 1 hrs later exp warmth, nausea, & chills; 3 hrs p/vax exp a fever of 103, vomiting, diarrhea, lightheadedness, inc HR 120 per min, BP 92/46, SOB;
arm is sore/The muscle at the shots site felt worse; The muscle at the shots site felt worse; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th July 2022, the patient received Shingles vaccine. On 6th July 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and injection site muscle pain. On an unknown date, the outcome of the pain in arm and injection site muscle pain were unknown.   It was unknown if the reporter considered the pain in arm and injection site muscle pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-July-2022 Reporter's Comment: The patient got his/her shot the day before reporting actually and by the nighttime the muscle at the shots site felt worse than the Covid shot. Same arm too lol but they really stick you lol. The patient's arm was sore. Additional supportive information: This case has been linked to the case US2022AMR105380 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105380:tag at post
Patient stated that she is not allergic to any vaccines and drugs in the past and that this vaccine is just a booster shot. After she received the vaccine she slowly fainted and then cease for a few seconds. We tried to lay her on the ground, as soon as we got her to the ground she regain her consciousness and then she was okay.
This spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who received flu vaccine. This case deals with tenth report out of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 20-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number: 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case-correction received on 10-Aug-2017: The narrative and case comment were corrected.
Pt given expired vaccine. GSK was called and there is no data with any adverse reactions. CDC recommends revaccination.
For the first 2 days after the immunizations, pt had fever and lethargy.  After that resolved pt had 3 post-prandial episodes (the first 2 within the week after immunization administration) where she was falling asleep and then started rhythmic unsuppressible upper extremity shaking with unresponsiveness and fluttering eyelids lasting 30 seconds each.  After these episodes the pt would fall asleep.  The 3rd episode was on 8/9 and the pt was admitted to rule out seizures.  During these episodes she did not have any cyanosis, apnea, eye deviation, fevers during these episodes and was otherwise well.
Fever, no itching of the site, pain with lifting, no trouble breathing, wheezing or throat tightness.
Area of redness and swelling diameter ~ 4 1/2" L anterior thigh - no heat or tenderness.
Pain (Rt) shoulder/arm - Hep B injection 10/31/08.
Crying a lot, fever 102.3, on thighs where shots were given area of redness and induration. F/u 1 week use warm soaks & massage.
Itching, swelling and large rash at vaccination site.   Very warm to the touch. Under arm pain. Shortness of breath. Mild occasional headaches.
pt recv vax 6SEP95 & 26OCT96 pt had a negative titer;
Headache, Myalgia,  h/a, fatigue, body aches, diarrhea, Narrative:
Filing pression on my chest; My hearth I was filing like was bigger; He hearth rate I was feeling slow; I started filing short of breath; This is a spontaneous report from a contactable consumer. This 55-year-old female (Non-pregnant) consumer (patient) reported that himself received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date not reported), via an unspecified route of administration in Left arm on 06Apr2021 at 09:00 AM (Age at Vaccination 55-year-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date not reported), via an unspecified route of administration in Left arm on 27Apr2021 at 09:15 AM, (Age at Vaccination 55-year-old) as a dose 2, single for covid-19 immunisation. Patient had no Known allergies. On 13Apr2021 8 days after patient had her first vaccine doses, patient started filing pression on my chest, and my heart she was filing like was bigger and the hearth rate she was feeling slow. The feeling was bothering all day, until she started filing short of breath. when to the hospital that day, but I wait too long and I decided to leave, two days later I went to my primary doctor, they did an EKG and told me was normal, the I went to a Cardiologist and he told me that was probably my muscle, but that I was fine. The outcome of the events recovered.  Follow up (12Jul2021): This is a follow up-spontaneous report from a contactable nurse. This nurse reported for the patient in response to HCP letter [sent to other HCP] via follow-up letter which included   Information on lot/batch number has been requested.
Intense muscle aches, nausea, site swelling 4 inches x 2 inches, hives neck/chest.
Received Pfizer first dose at 7:52am.  While in Observation area of Vaccination Clinic (with a recommended 30 min observation time), within 15 min patient complained of "Itchy arms".  I noticed red, blotchy rash on her chest.  She stated her breathing was fine/no issues with breathing.  Elevated her feet. BP= 123/85, O2Sats= 98%.  Patient said she had pre-medicated with Benadryl and had an Albuterol inhaler and Epi Pen she had brought with her to her Vaccination appointment.  She then started clearing her throat.  Epi pen recommended for her to take-> she declined, stating her breathing was fine, and its too painful to take and bruises her skin and wasn't having trouble breathing.  Patient brought to Emergency room within hospital.