chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOSS OF CONSCIOUSNESS (Loss of consciousness, Loss of consciousness)  HYPOTENSIVE (Hypotensive, Hypotension) This spontaneous report received from a physician concerned a multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced loss of consciousness. On 11-MAR-2021, the subject experienced hypotensive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patients was recovering from loss of consciousness, and hypotensive.  Reporter considered causality between covid-19 vaccine ad26.cov2.s and  loss of consciousness,  and hypotensive as possible.  Company causality between  covid-19 vaccine ad26.cov2.s and  loss of consciousness, and hypotensive considered as possible.  This report was serious (Other Medically Important Condition).
I received a flu shot. When I got the shot, my arm bled. I received a bump and a bruise. Soon after my shot, I received a large dark bruise and a welt. My arm hurt. 12/16/02 Patient saw both her school nurse and a physician. The physician saw the injury 3 days after the shot. His diagnosis was that her arm was infected, but that the antibiotics she was already taking probably helped with the arm infection.
PAINFUL LUMP ON ARMPIT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-APR-2021 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 08-APR-2021, the subject experienced painful lump on armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of painful lump on armpit was not reported. This report was non-serious.
a patient was administered a booster dose of MENACTRA at 15 and half years old. The patient was previously administered the first dose of MENACTRA at 11 years, 8 months and 3 days old with no reported adverse event; Initial information was received on 02-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 years old patient of unknown gender who received a booster dose of meningococcal a-c-y-w135 (d conj) vaccine [menactra], the patient was previously administered the first dose of menactra at 11 years, 8 months and 3 days old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, a patient was administered a booster dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (dose, strength, lot number, route, administration site, expiration date: Unknown) for Immunization (immunisation) at 15 and half years old. the patient was previously administered the first dose of menactra at 11 years, 8 months and 3 days old with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event a patient was administered a booster dose of menactra at 15 and half years old. the patient was previously administered the first dose of menactra at 11 years, 8 months and 3 days old with no reported adverse event  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 the 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.
Left upper arm swelling and pain. Offered oral prednisone to her to help counteract reaction given that it is still swollen but since she feels ROM is improving, prefers to cont with heat and gentle stretches. Stay on ZYRTEC until swelling resolves.
20.5 x 9.5 cm red raised tender swelling around and distal to injection site.
Provider documentation: "Patient is a 76-year-old female vaccinated against COVID with a past medical history of chronic obstructive pulmonary disease/asthma, cirrhosis secondary to NASH, type 2 diabetes mellitus who presents with COVID 19 pneumonia. Initially required 50% FiO2 on 15L with venti mask now on 4-5 L NC (5L with exertion). Negative right lower extremity venous ultrasound and CT PE for pulmonary embolism.  Echo showed grade 1 diastolic dysfunction a small pericardial effusion.   She completed a 5 day course of remdesivir.  Completed 10 day course of Decadron.  She received 4 days of IV Lasix with improvement in her oxygenation.  This was not continued on discharge.  Physical therapy occupational therapy evaluated patient.  SNFversus home with assist and patient/family elected to return home with assistance and home health care."
I should point out that I donated a pint of blood 2 hours before getting my Moderna shot. I thought it would 27 hours before the shot but after donating the pharmacy called and said they had vaccine available if we wanted to move  up getting our shots right then 24 hours before our appointment.  8 hours later,  at 3:00am I got up to go to the bathroom. I immediately started feeling nauseous and light headed. I ended up collapsing and falling flat on my back. I immediately started shivering and shaking along with the nausea. For the next 12 hours I was extremely weak and my joints severely ached. It was very hard to move.   The total experience lasted roughly 18 hours before I started feeling significantly better.  Before donating blood I asked the if getting the Moderna Covid shot 27 hours (I thought 27 hours at that time) after donating would be a problem .  They said no. We asked the pharmacist before getting the shot if donating blood 2 hours earlier would be a problem. She thought naught and said she had no guidance against it.  I?m a very very healthy 67 year old. I rarely get sick and I have no prescriptions.  Complicating my blood donation was that my pulse was 44 beats per minute but my good health allowed them to proceed.  I?m not complaining about anyone or anything. I just thought you should be advised of my experience.
12cm x 7cm area of erythema & induration + pruritis (mild). History of varicella @ 1 mos of age.
Neurological symptoms. These include shaking, jerking, spasms, Each episode lasting minutes to hours. Low grade fever the first night after administration of the vaccine was noted.  Resident is unable to control these movements. It appears to be dystonia vs another movement disorder. Resident is aware these episodes are occurring.  Resident is very distressed over the movements.  Tremors also noted at times.
Patient is a 80 yo M w/ hx of dementia, HLD, GERD, CKD-3, pAflutter, BIBA for syncopal episodes x2. Majority of history from wife as pt is a very poor historian. States that he has been in usual state of health up until earlier today when he was sitting at the table and slumped over while waiting for his lunch. Episode was witnessed by his wife who noted he was making a gurgling sound but did not display any convulsive movements. At that point he regained consciousness and did not display any post-ictal signs. Wife called 911, paramedics checked vitals which were all wnl and pt declined coming to the hospital. He then took a 3h nap which is unusual for him. Upon awakening he had another syncopal episode witnessed by wife and called 911 to bring him to the hospital. Pt states he feels fine but is unable to provide any history about the events that occurred. Wife notes son who lives with them is also COVID+, pt found to be incidentally COVID+ in ED.
Severe muscle pain, arthritis pain, sensitivity to light, sinus pressure, pain around rib cage
Pt had sl fever on 17SEP91 during the day; mom stated pt temp was much higher during night but temp not taken; t104 R  AM 18SEP91; mom stated pt fussy & up all night; Mom instructed to have pt checked by MD; tenderness @ inject site;
pt recv vax 25MAR99 & w/in 12-24hr pt c/o chills, h/a, fever, arthralgia & anorexia;the flu like sx started to resolve but still c/o severe anorexia;29MAR99 liver function tests showed: AST 1529, ALT 1455, alk phos 307, total bilirubin 4.1;
Suspected vaccination failure; Shingles; had 3shots; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: had 3shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that all together he/she had the three shingles shots and he/she had shingles now. The reporter further stated that it might be more severe if he/she did not. 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. The patient had three shingles shots of shingles vaccine, which led to extra dose administered.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 82.46  No concomitant medications were reported. The vial underwent temperature excursion on 07-Jan-2021 with temperature 34 degrees Fahrenheit and the vial was initially moved to the fridge on 05-Jan-2021 and proposed beyond use date was 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
anxiety; dizziness and lightheadedness; dizziness and lightheadedness; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer (patient). A 67-year-old female patient received first dose BNT162B2 of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route, on 26Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously took flu shot for immunization and was sick for 34 days afterwards. The patient experienced anxiety, dizziness and lightheadedness on an unknown date in 2021 after first dose. She was concerned about receiving the second dose because of the side effects. She also asked about the vaccine not being FDA approved and wants to know if it was safe for her to receive it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The individual tested positive for COVID-19 on 6/23 with a PCR test that was done at Medical Center, when the case arrived because he was experiencing nausea and vomiting and there was blood in his vomit. He vomited twice and the first time the blood was lighter, and the second time it was darker, so he decided to seek emergency medical treatment at the hospital. The patient continues to be currently hospitalized (today is 6/25/21). His primary care doctor. And the Hospital Doctor seeing him is a GI specialist.
This spontaneous report as received from a nurse via a company representative refers to a 11 year old female patient. Patient did not specify specific medical history. No drug reactions/allergies were reported. On 12-AUG-2015 patient was vaccinated with GARDASIL 9 (strength, dose, route were unspecified by the reporter). Concomitant therapies included meningococcal vaccine (unspecified). On 12-AUG-2015, patient experienced syncope after receiving treatment with GARDASIL 9. Reporter stated that patient did not receive any treatment for the event syncope. On 12-AUG-2015 patient recovered during the office visit from syncope. There was no product quality complaint involved. Reporter's causality statement was not reported at the time of the report. This is one of the two reports received from the same reporter (MARRS # 1508USA006794). Additional information has been requested.
Developed considerable chills in mid afternoon after the a.m dose, then temperature of 103 by early evening.   103 fever lasted for hours, then late evening, began to drop to 101.  Headache, body aches, light headedness/off balance.  Disoriented.   Awful chills began again throughout the night.    The following morning; (22nd), fever remained at 101 - then late morning, the  fever was gone, though still off balance and somewhat lightheaded.    Body aches remain as well as headache.
Sharp pain in the heart resulting in difficulty breathing deeply. Pain was severe that I could not get out of the bed for 30 minutes. Overall, pain lasted about an hour.
administration of an expired Boostrix dose to a 11 year-old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number J39HG, expiry date 05-JUN-2023) for prophylaxis.   On 07-JUN-2023, the patient received Boostrix. On 07-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Boostrix dose to a 11 year-old female patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-JUN-2023 The health care professional (HCP) asked for recommendations on this situation. The HCP provided this email address for follow up. The reporter consented to follow up. The patient received an expired dose of Boostrix, which led to expired vaccine used
20 minutes after receiving the vaccine I started to feel swelling in my throat and a hot, tingling feeling on the inside surfaces of my mouth and tongue, my arm was also very itchy and had a lump approximately the size of half a golf ball at the injection site. I developed a severe headache as well. 23 minutes after the vaccine, I took 25 mg of Benedryl PO, 38 minutes after the vaccine, I took an additional 25 mg of Benedryl PO and 10 mg Zyrtec PO because my symptoms had not yet resolved. Approximately 1.5 hours after the vaccine administration my symptoms resolved, except for the headache and the lump on my arm.
Patient describes severe fatigue with nausea and vomiting within 24 hours which lasted several days. One week later developed vertigo which continues although does have symptom free periods intermitently
11:39Chest tightness, clients albuterol inhaler- 11:58 feeling the need to "clear throat", dizziness, leg weakness increased heart rate 25mg benadryl. symptoms resolved at 12:42
On the 2nd day after the shot, I had bad body aches, also at the site of injection my right arm had a 2 inch red round circle, a little raised and hot.
Pt is a 56 y.o. male with relapsing/remitting MS (on rituximab, with baseline lower extremity weakness) who presents with fever, cough, and recrudescence of extremity weakness due to COVID-19 infection. He received monoclonal ab therapy on 11/24. His extremity weakness improved and he was d/c to home on 11/26 in stable condition, with home PT services.    The patient is hemodynamically stable and is on room air in no respiratory distress. He is currently minimally symptomatic aside from the weakness. He is immunocompromised due to being on rituximab and there have been concerns from his outpatient doctor about his ability to mount an immune response (note he is fully vaccinated against COVID-19). Patient does not meet criteria for dexamethasone (not requiring supplemental oxygen). His main driver for hospitalization is profound weakness. Applied for emergency compassionate use of monoclonal Abs (casirivimab and imdevimab) for COVID-19 (11/24) - have received approval from the company authorities at the HCF. Monoclonal ab given 11/24.  Remained on RA with minimal respiratory symptoms, simply a mild dry cough. He was d/c to home in stable condition.
Child was administered Pediatric Pfizer 5-11 years.  After the child and his mother left the facility, I realized that I had not diluted the vaccine prior to administering it.  Mom is an HCP and will be keeping a close eye on him.  4/18/22- spoke with mom several times over the last 4 days- states that Friday 4/15/22 patient had chills, fatigue, sore arm but as of 4/18/22 he was back to his normal self.  Mom also spoke to patient's infectious disease physician who "was not concerned at all".
tested positive to COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive to COVID 19) in a male patient of an unknown age 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 23-Jan-2021, the patient experienced COVID-19 (tested positive to COVID 19). At the time of the report, COVID-19 (tested positive to COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that he was scheduled to receive his second shot of MODERNA COVID 19 Vaccine on 11FEB2021, but tested positive to COVID 19 on 23-JAN-2021, and was told to wait for fourteen days. No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.  Company comment: This spontaneous case concerns a male patient of an unknown age with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred within the month after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred within the month after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Pain at injection site with itching, redness and mild inflammation in a 15 cm area. Treated with warm packs to site and injection Depomedrol 40 mg IM times one.
Mom calls clinic & reports area on left thigh the size of orange, hard to touch & warm. Area described as that of immunization.
Information has been received from a consumer concerning her 14 year old daughter who on 28-JUN-2010 was vaccinated with the third dose of GARDASIL (lot number unknown). The consumer reported that on 28-JUN-2010 her daughter had experienced headache, numb sensation in her fingers and twitching after receiving her third dose of GARDASIL. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Information has been received from a physician, for the pregnancy registry for GARDASIL, concerning an 18 year old female with a history of 2 pregnancies, 2 elective terminations, 0 live births and no other medical history who on 27-May-2008 was vaccinated with the second dose of GARDASIL (lot#659964/1978U). There was no concomitant medication. Subsequently, she became pregnant and her LMP was 26-Jul-2008. On 30-Aug-2008, about 5 weeks from her LMP, the patient underwent elective termination. Upon internal review, elective termination was determined to be an other important medical event. Additional information has been requested.
Fever, seizure activity. MR recived for a o/n ER admit for c/o fever and seizure activity. PE: WNL with notation of a painful mass in the right periauricular region with erythema and purulent discharge. Treated with anti-pyretics, Rocephin, and diet. Final DX: Viral illness, Febrile seizure.