chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gentleman received his 2nd dose Pfzier Covid 19, and 10-15 minutes later complained or trouble breathing. Had him sit down, called 911 and monitored breathing. Said he started feeling better and when EMS showed up they took vitals and suggested the gentleman go to the ER for further evaluation to make sure he was ok.  NO Benadryl/epinephrine was administered.
DEATH; CLOTS; HEART ISSUES; This spontaneous report received from a consumer from company representative via media concerned multiple patients. The patients weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total start therapy date were not reported for covid-19 prophylaxis. 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 patients had clots, heart issues and died. On an unspecified date, the patients died from unknown cause of death. It was unknown whether the autopsy was performed. It was reported that, "What about all the young men who took it and now have clots, heart issues and death." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of clots and heart issues was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20221003651 and 20221005731.; Sender's Comments: V0- 20221003655-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20221003655-covid-19 vaccine ad26.cov2.s-Clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Initially started with tingling sensation in my scalp on the right side, then next day the left side of my forehead were sensitive. Then next day started with shooting pain to my forehead, eyes, ear and throat this continued the following day along with dull headache by Tuesday, I could barely work, Worse headache every and light-sensitivity to left eye. Saw PCP on Wednesday, I thought I was getting Shingles but no rash. He treated be for migraine, which I never had, for my eye was tearing. I woke up Thursday with me left eye swollen and matted, with continuing constant headache with frequent shooting pain. I then went to my eye doctor who started me on Valtrex for possible shingles. It was Friday when the rash first appeared which confirmed I had shingles. Needless to say, I wasn't able to open my eye due to the swelling for about a week, then I had TNTC (too numerous to count) floaters in the same eye. Along with blurred to double vision. I just had my last follow-up with the eye doctor this past Tuesday. (Sept 14, 2021).  I am not 100% but almost, Still having a few floaters and occasional blurred vision if I am tired
This spontaneous report was received from a healthcare worker and refers to a 5 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored PROQUAD (Merck) lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Six hours after receiving my 2nd Moderna vaccine, my blood glucose (BG) levels began rise more than usual. Since I'd just eaten dinner, I did not immediately deliver extra insulin. However, before going to bed, my BG level was even higher, so I delivered a corrective bolus using my Tandem insulin pump. I also use the Dexcom Continuous Glucose Monitoring System. Overnight, every time I woke up & checked my BG level, it was rising & rising, & so I continued to deliver corrective boluses. At 4:30 am this morning, I awoke, checked my BG level, & it was off the top of the graph on my pump; I used a fingerstick glucometer, & found that my level was 449, a dangerously high level. I delivered another corrective bolus, but my BG level would just not go down. I emailed my doctor, who instructed me to change my pump infusion site (I had actually done that about 5 hours following receiving the vaccine, but changed it again), delivered a 5-unit corrective bolus via syringe (shot) & checked my ketone level, finding that my ketones were extremely large, >160. I contacted the doctor's office again, & was instructed to consume a LOT of water, watch my BG level & check my ketones & inject 2- to 3-unit doses every hour. I did this all day today. By noon, my ketones had fallen to "negative" & my BG level had fallen to 169. It has continued to be a MAJOR struggle to keep my ketones in the negative range & my BG level anywhere near where it was prior to the Moderna vaccine. I don't know how long this will last, & I am AFRAID.
Initial report received on 31 July 2009 from a health care professional. A 12-year-old male patient, who had no concurrent illnesses, pre-existing medical conditions, or use of other medications had received on 30 July 2009 an intramuscular left deltoid injection of ADACEL (lot number C2862AA); an intramuscular left deltoid injection of MENACTRA (lot number U2656AA); and an intramuscular right deltoid injection of VARIVAX (manufacturer Merck, lot number 0193Y). Per the reporter, on 30 July 2009 the patient had received the vaccines and became pale, lightheaded, had blurred vision and could not feel his arms and legs. The symptoms lasted four minutes and the patient fully recovered. It was not reported whether the patient required any medical interventions at the time. Documents held by sender: None.
Woke up a few days after having received vaccine, and abduction of right (injected) arm was greatly reduced from the night before. There was also severe pain at the site of injection. Abduction decreasing steadily until date of report. Size of right arm decreasing steadily in comparison to left arm. This condition was absent just prior to being given the vaccine.
CHIEF COMPLAINT  is a 60 y.o. female who presents with dyspnea.    HISTORY OF PRESENT ILLNESS 60-year-old female from  memory unit presents with dyspnea and oxygen desaturations.  She does have advanced COPD and is on chronic oxygen at 3 L. She presents to the emergency room and test positive for COVID.  She did desaturate into the low 80s several times during her evaluation in the emergency department.  For this reason she is being admitted for treatment of COVID pneumonia with hypoxia.  She is on multiple medications for depression and sinus tachycardia.  She does have cognitive impairment.
Caller stated that on 8/19/2020, the patient was administered improperly stored VARlVAX; This spontaneous report was received from a registered nurse, referring to a 4-year-old female patient. The patients' pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 19-AUG-2020, at the age of 4-year-old, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T002848, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022), as prophylaxis (product storage error). As concomitant therapy, a properly stored sterile diluent (MERCK STERILE DILUENT) (lot number S008566, which has been verified to be valid, expiration date reported and validated as 16-NOV-2021) was used to reconstitute the vaccine (medication dilution). The vaccine administered was stored at temperatures that went, from -14 degrees Celsius (C) to -10C (-12.1C) for a time frame of 3 hours, and from -9C to 8C (-7.5C) for 8 hours 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA004106:
Myalgias developed 9/11/02. Increase SOB. Seen 9/23/02 with bilat pneumonia. Rx started Levaquin. Got worse. Admitted to hosp 9/24 with ARD's. No etiol. found despite extensive work-up. Died 10/20/02.
A few hours following vaccines patient developed a diffused urticarial rash/lesions throughout the body. Patient treated with BENADRYL and referred to an allergist.
I63.511 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 4/22/2023 DYSARTHRIA, LATE EFFECT OF ISCHEMIC STROKE I63.9 REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 4/27/2023 DYSARTHRIA, LATE EFFECT OF ISCHEMIC STROKE I63.511 ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 4/22/2023 ANEMIA DUE TO CKD I63.9 REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 4/27/2023 ANEMIA DUE TO CKD
Trouble regulating body temperature.  Vaccine created low blood pressure. Needs to check blood pressure 6x time a day. Stay extremely hot, drink excessive amounts of water.
devel coryza, sore throat, fever, chills on 9/8/99;fever, chills resolved on 9/11/99;devel a sl itchy red maculopapular rash on face which spread over body, limbs sparing palms, soles;seen by MD 9/13/99;
This spontaneous report as received from a Registered Nurse refers to a 10 year old male patient with allergy to amoxicillin. There was no pertinent medical history. On 20-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular in the left arm) for history of hereditary spherocytosis. On 20-JAN-2014 the patient's left arm swelled up, was really red, hot to the touch, and had pain from mid deltoid down to the wrist. There was no treatment given for the events. No lab diagnostics studies performed. The patient sought medical attention by an office visit. The outcome of the events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
I had my vaccination on 09/08/2022. In 09/2022 I had increased abdominal pain. I had to have Endoscopic retrograde cholangiopancreatograph done to clear out the sludge in the biliary tract.
3 miscarriages; Hashimoto; several swollen lymph nodes; My arms and legs are burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "3 miscarriages"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "several swollen lymph nodes"; BURNING SENSATION (non-serious), outcome "unknown", described as "My arms and legs are burning". The pregnancy resulted in spontaneous abortion.  Clinical course: Since receiving 2 Covid 19 Pfizer vaccines and a booster, her health has taken a dive. She have several swollen lymph nodes that hurt & haven't gone away for over a year and more are appearing. Her arms and legs are burning, she have had 3 miscarriages, and she have been diagnosed with Hashimoto's. Is there a way to flush my body of the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201087034 similar report from same reporter;US-PFIZER INC-202201087035 similar report from same reporter;
Patient completed immunizations on schedule. Was found positive for Bordetella Pertussis around 3/28/03. Had three DTaP doses prior to illness. DTaP vaccine failure.
Low grade fever, (99.0 to 99,6), slight head ache, lethargic.  Symptoms gone in 12  to 18 hours.
I have been taking flu shot for the last three years even though I am allergic to eggs. I had no allergy problem after taking flu shot. But, this year, I took flu shot in the end of September and on 10/18/2010 had severe stomach ache and nausea which are the symptoms I get after eating egg. I don't know why I am having these adverse reactions this time. I am constantly having nausea and stomach ache. I got every thing checked but doctors have not found anything. I don't know what to do. Any suggestions?
red swelling rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red swelling rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red swelling rash). At the time of the report, RASH ERYTHEMATOUS (red swelling rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment information included after bite cream.
Initial information received from an office manager on 17 October 2014; the case is not considered to be medically confirmed. A twenty-nine year old female patient was vaccinated with an intradermal injection of Influenza Intradermal, batch and site not reported on 15 October 2014. The patient's medical history was not reported. On 17 October 2014, two days post vaccination, the patient was "claiming cellulitis". It was unknown by the reporter if the cellulitis was physician diagnosed or if it was diagnosed by the patient herself. The patient was not seen by a physician at the reporter's facility. Laboratory tests were not reported. No further details were available at the time of this report. The patient outcome is unknown. Documents held by sender: None.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HLD" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "inflamm arthritis" (unspecified if ongoing); "MDD" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Dulcolax, reaction(s): "known allergies: dulcolax", notes: known allergies: dulcolax, ceclor, dilaudid, novacaine; Ceclor, reaction(s): "known allergies: ceclor"; Dilaudid, reaction(s): "known allergies:dilaudid"; Novacaine, reaction(s): "known allergies: novacaine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative shortly after (21Nov, and 22Nov); (unspecified date) Positive, notes: rested positive for covid this am (all home tests); (13Nov2022) Positive, notes: pt tested positive on 13Nov started paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient tested positive on 13Nov treated with Paxlovid, treatment start date=13Nov2022, treatment stop date=17Nov2022, finished course; no complications; tested negative shortly after (21Nov, and 22Nov); then symptoms restarted on 22Nov pm and rested positive for covid this am (all home tests).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Later same day as shot (4-19-2021)  had bad left hip pain and backache. Next day Tuesday ( 4-20-21) every joint and muscle hurt bad with temp of 100.1F. Today Wenesday (4-21-21) feel drained,  temp back to normal.
PATIENT REPORTED NAUSEA, DIARRHEA, DIZZINESS. PHARMACIST RECOMMENDED PEDIALYTE, PEPTO-BISMAL, BENADRYL, HYDRATION, AND STAY AT HOME. PATIENT WAS RESTING AT HOME AT LAST PHONE CONVERSATION 7/31/21.
Patient was vaccinated at 9:21 am on 1/5/2021 after review of consent forms and questions answered. Patient was asked if she had any adverse reactions to vaccine or products containing polyethylene glycol ( bowel preps/ cosmetics/ lotions). Patient denied any allergies except to Penicillin. Patient consented to receive vaccine. Pfizer Covid vaccine administered at 9:21 am. No immediate reaction. Patient denied any pain at injection site. Patient escorted to observation area. At 9:30 am the patient complained of nausea and proceeded with dry heaves. Patient did state she had eaten in the morning. Patient with good radial pulses at rate of 88. Patient then stated she felt dizzy and patient was assisted to the floor and placed in a recovery position. The patient DID NOT have change in mental status or decrease in mental status. Initial BP 162/102 - HR 88. Patient continued with nausea, dry heaves and dizziness. 911 was called. Patient maintained a BP of 160-172 systolic and pulse rate of 120, RR 40. Patient WITHOUT rash, swelling, wheezing, SOB or change in LOC. Benadryl was administered at 0945. Medics arrived at 9:47. Patient was transported to local hospital. No change in patient status upon departure. Patient remained nauseated, with dry heaves and dizziness.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006541: US-009507513-1712USA006543: US-009507513-1712USA006544: US-009507513-1712USA006545.
22-month-old patient was given QUADRACEL vaccine formulated for a 46-year-old with no reported adverse event; Initial information was received on 14-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 22 months old male patient was given diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) (quadracel) vaccine formulated for a 4 to 6-year-old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine; and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13).  On 12-Jul-2023, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine(Suspension for injection) (strength was unknown) lot U7564AA, Expiry date : 08-Nov-2024) via intramuscular route in the right thigh for Imunization.  On 12-Jul-2023 the patient developed a non-serious event of 22-month-old patient was given quadracel vaccine formulated for a 4 to 6-year-old with no reported adverse event (wrong product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS and ipv VACCINE (Quadracel) was not applicable.  At time of reporting, the outcome was Unknown for the event 22-month-old patient was given quadracel vaccine formulated for a 4 to 6-year-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 guidelines. 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.
This case was reported by a consumer and described the occurrence of worn out in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (In August 2018). On 30th January 2019 09:00, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced worn out, injection site pain, injection site erythema and injection site lump. On 30th January 2019, the patient experienced shivering and general body pain. On 30th January 2019 16:00, the patient experienced cramps calf. On 31st January 2019, the patient experienced muscle pain. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the worn out, injection site pain, cramps calf, shivering, general body pain and injection site erythema were unknown and the outcome of the injection site lump was not recovered/not resolved and the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the worn out, injection site pain, cramps calf, shivering, general body pain, injection site erythema, injection site lump and muscle pain to be related to SHINGRIX. Rerun. Additional details were reported as follows: The patient received SHINGRIX on left arm early the previous week before the day of reporting and was in bed for 2 to 3 days feeling wiped out and a very sore injection site on her arm. The patient stated she had mentioned her reaction to the SHINGRIX received on Wednesday. The patient had shingles in August and wanted to know if this could be why she had the reactions to SHINGRIX. At 4:00 pm 7 hours after vaccination, she started to experience a cramp in her left calf that went up through her back to her neck. The patient went to bed after dinner and began shivering from inside herself and her body started to hurt. The patient took one TYLENOL and one ibuprofen which seemed to calm down her shivers after a couple of hours. The patient experienced body and muscle aches the entire next day and was not able to go to work. These symptoms were better by Friday morning but it felt as if someone punched her in her left arm and she had a large red lump at the site of the injection. By Sunday, the lump was larger than a half dollar coin, still red and a little tender. This continued to improve but she could still feel a small lump at the site of the injection on the day of reporting.