chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 10:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 10:33 AM, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   Age of patient was reported as 32.31.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021, 13-Feb-2021,14-Feb-2021, 17-Feb-2021 with temperature 20, 35, 32 degrees Fahrenheit from 08:00 AM to 03:00PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 03-Mar-2021, 10-Mar-2021. Product moved to clinic on 13-Jan-2021, 12-Feb-2021, 17-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period 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 brand traceable temperature monitor at every hour.  No treatment medications were reported. No concomitant medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Menstrual cycle is no longer consistent. I was always 28 days; however, now it is 30+ days up to 38 days. My periods have become very heavy, large clots and last over a week and then another week  sporadic of spotting. My cycle is inconsistent and no longer normal from what I am used to.  My periods have increased in pain and I will have surges of pain in my ovaries.
2nd dose of Moderna Vaccination (Lot Number:020B21A) given at 23 days after first dose administered. First dose given 04/01/2021. Second Dose Given 04/23/2021
pt was lightheaded, itchy throat, sts same occured w first dose.  BP 125/89 , SPO2 100. 1200;  experienced vertigo .  RN called driver  vitals repeated at 1226 135/92, SPO2 100 , resp 100 rapid response called at 1226
inability to concentrate; Injection site soreness; sore shoulder; sore finger knuckles; insomnia; nausea; vomiting; confusion; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration on 15Feb2021 at 11:00 (at the age of 46-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included known allergies to sulfa medications. Concomitant medications in two weeks were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ16850), via an unspecified route of administration on 21Jan2021 at 11:00 AM (at the age of 46-year-old), as single dose in left arm for COVID-19 immunization. Patient did not receive any other vaccine in four weeks after COVID vaccine. On 15Feb2021 at 22:00, 11 hours after second dose of vaccine, the patient experienced injection site soreness, sore shoulder, sore finger knuckles, insomnia, nausea, vomiting, confusion, and inability to concentrate. Patient did not receive treatment for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was resolving.    Follow-up attempts completed. No further information expected.
dizzy; foggy; diaphoretic; blurred vision; nausea; had one episode of vomiting; This is a spontaneous report from a contactable pharmacist. A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN5318/expiration date: not provided), via intramuscular route of administration, on 23Jan2021 12:00 (at the age of 32 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient did not have any known allergies. On 23Jan2021 at 12:00 immediately after the injection, the patient felt dizzy, foggy, diaphoretic, had blurred vision, nausea and had one episode of vomiting. The patient did not receive any treatment for these events. After the patient had emesis episode, the patient immediately returned to baseline and felt better. The patient stated that he normally had some type of reactions after injections. The patient was observed for a full 30 minutes and given water. 1225 patient check on and a this time had made a complete return to baseline. Patient discharge home after his full 30minute observation period ended at 1230. The outcome of the events dizzy, foggy, diaphoretic, had blurred vision, nausea and had one episode of vomiting was recovered 23Jan2021 at 12:30.
Approximately 3 weeks after the second vaccine, I developed a bruise (yellow/black/orange) on the right inner thigh.  After one week later, the bruise covered the entire right inner thigh.  At the same time, the left inner thigh developed a bruise.  After one week later, the bruise covered  about half of the left inner thigh.  By the end of approximately three weeks from the initial bruising, all bruises were subsiding, and by the fourth week, all bruises disappeared. From this time onwards, I experience nose bleeds, after from coming out from the shower.  These occur about once monthly.
She received one dose of the Pfizer COVID-19 vaccine and died ten days later; This is a literature report.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "major neurocognitive disorder" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "home hospice" (unspecified if ongoing); "significantly deteriorated" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), 10 days after the suspect product(s) administration, outcome "fatal", described as "She received one dose of the Pfizer COVID-19 vaccine and died ten days later". The patient date of death was unknown. Reported cause of death: "She received one dose of the Pfizer COVID-19 vaccine and died ten days later". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Death cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: She received one dose of the Pfizer COVID-19 vaccine and died ten days later
Sore arm several hours after shot lasting 2 days. Nausea and Headache daily since injection.
Did not have any energy/Low energy; Felt hot; Sweaty; Fatigue; Felt feverish; This spontaneous case was received on 03-Sep-2020 from other non-health professional via agency (reference number: SEQW20-01208) with an additional document received on 08-Sep-2020 (being processed together) and concerned a 73-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 25-Aug-2020, patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 mg (as reported), anatomical location: reported as left, route od administration: not reported) for an influenza prophylaxis.   The batch number was not reported.  On 26-Aug-2020, one day after receiving Fluad Quad, the patient experienced fatigue, she had no energy, felt hot and sweaty. She checked her temperature and did not have a temperature but felt feverish. The patient called her health care professional (HCP) and the pharmacy and took acetaminophen.   At the time of initial reporting on 03-Sep-2020, the patient was recovering from the events. She was some better, but not completely.   The reporter did not provide a causality assessment.  Company comment: Asthenia, feeling hot, hyperhidrosis, fatigue and pyrexia were associated with the use of the suspect product Fluad Quad. The events occurred one day after receiving the product. Chronology seems plausible. The patient started recovering from the events with corrective treatment. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events (except for fatigue for which causality was assessed as unlikely due to reported asthenia/ low energy) considering temporal association and lack of confounders. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: Asthenia, feeling hot, hyperhidrosis, fatigue and pyrexia were associated with the use of the suspect product Fluad Quad. The events occurred one day after receiving the product. Chronology seems plausible. The patient started recovering from the events with corrective treatment. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events (except for fatigue for which causality was assessed as unlikely due to reported asthenia/ low energy) considering temporal association and lack of confounders. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)
This was the COVID Pfizer booster.   I normally take 35 units of Toujeo to control diabetes.  The morning after my booster 9/28 , my Fasting Glucose was 82 , the following morning 9/29 it was 68 and the following morning 9/30 it was 45.  That evening I did not take my Toujeo and my fasting was 69 on 10/1.  That evening of 10/1,  I took 24 units of Toujeo.  My fasting sugar on 10/2 was 95, on 10/3 it was 113 and I returned to my regular dosage of Toujeo and my sugars are running about 100 to 120.   I had a wellness exam today and the doctor encouraged me to do this report
This spontaneous report as received from a 63 year old consumer of unknown gender refers to himself/herself (weight 160 unit not provided). On 14-OCT-2013 the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expiration date unknown). Approximately in October 2013 the patient had red circle around where the injection was given, like and orange size. The patient didn't have fever and it didn't bother him/her, but it was just red. The outcome of the event was unknown. Additional information is not expected.
p/inject BP 160/90 not taken in past yr; 30APR asymptomatic; 1MAY  weird sensation, sl blurry vision; BP 204/104; P 114, 110;
2 days of flu symptom including extreme fatigue, aches, chills, requiring sleeping during the day, 3rd day very tired,  days 4-10 sore throat, headache, swollen glands still continuing but beginning to improve on day 9
bruise @ inject site & chest pressure are reported in a pt receiving 1 dose of fluogen given on 4NOV93; pt exp chest pressure the following day which only lasted a few minutes; pt also exp burise @ inject site which abated the next day;
Uncharacteristic menstrual bleeding. No menstruation for 12 years due to IUD.
jittery (local to upper body); fast heartbeat; tightness in chest; lightheaded; swelling of tongue; over all general discomfort; swelling of throat; A spontaneous report () was received from a consumer  concerning a 72 years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced jittery (local to upper body) (feeling jittery), fast heartbeat (tachycardia), light headed (dizziness), swelling tongue (swollen tongue), swelling throat (pharyngeal swelling), tightness in chest (chest discomfort) and overall discomfort (discomfort).   The patient's medical history include allergic to Compazine as she experienced similar reactions 40 years back with Compazine.. The relevant concomitant medications were also not provided.  On 09 Feb 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:012M20A ) through intramuscular route of administration in the left arm for prophylaxis of COVID-19 infection.     On 09 Feb 2021, approximately at 6pm patient experienced jittery (local to the upper body) , fast heartbeat, tightness in chest, lightheaded, swelling of throat and sides of tongue, over all general discomfort. No laboratory data was provided.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events  jittery (local to the upper body) , fast heartbeat, tightness in chest, lightheaded, swelling of throat and sides of tongue, over all general discomfort were now subsided not completely by considerably(recovering).
8 days after receiving the first dose of Moderna, the arm where the injection was given is now inflamed and itchy.
25 y.o. female contact with military vaccinee (her boyfriend) shoulder from 2/14 - 2/17/03 Presented w/3 vesicular lesion proximal lateral aspect of right forearm. Assessment: 1) Probable Inadvertent inoculation (limited) in an unvax'd military contact. 2) Probable contact dermatitis to the right wrist.
Fever; Headache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Jul2021 at 18:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date. The patient had no known allergies reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of the COVID vaccine. On 06Jul2021 at 08:00, the patient experienced fever, headache, nausea and fatigue that lasted for 3 days. The events resulted in doctor or other healthcare professional office/clinic visit.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, headache, nausea and fatigue were resolved on 09Jul2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Moderate-severe urticarial rash - occurred few hours after (first) flu shot. No respiratory symptoms noted. Improved with oral steroids, but more so with oral antihistamines (BENADRYL & ATARAX).
Started with strong chills and shivering,  sudden body pain,  and diarrheas.  In the following hours symptoms incremented and started experimenting shortness of breath and chest pressure.  On April 30th, my MD ordered Respiratory Therapy   . Eventually visited a Cardiologist and a Neumologist due to the symptoms continued to worsened.
1st dose 8/21/2021, 2nd dose 9/21/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9727R, expiry date 27th January 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 21st September 2021, the patient received the 2nd dose of Shingrix. On 21st September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The case was reported by the registered pharmacist. On 21st August 2021, the patient received 1st dose of Shingrix. The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The Healthcare professional confirmed that, the patient was immunocompetent. The reporter consented to follow up.
Swelling of supraclavicular lymph nodes, cervical lymph nodes, axillary lymph nodes, and inguinal lymph nodes. Larve and very painful.
When I got the shot, nothing happened. My blood pressure was normal. The next day when I woke up, my heart problems had worsened and my blood pressure was high. Through out the day my blood pressure stayed high. Days later I spoke with a doctor and decided to go to urgent care. They triaged me there. They did vital signs and got me into a clinic examination room. They noticed my heart rate was fluctuating from 93 to 49 BPM. My heart rate had been dipping into the 40s. I didn't take the medicine I was given because of my already low heart rate. I was concerned that the medicine was going to make my heart rate drop even more. When I spoke to my cardiologist he said it may of been the vaccine that caused inflammation and problems with my heart rate. June 14th I went to the ER because my heart beats were severe. At the ER they agreed that it could've been the vaccine that caused the problems. The doctor said it may be inflammation that would resolve in time. It was an unusual heart beat pattern. The ER doctor told me to request an echocardiogram. The echocardiogram said I had atrial premature complex and left ventricular hypertrophy. After the 1st dose my high blood pressure went up but intensified after the 2nd dose.
high blood pressure; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and PAIN IN EXTREMITY (sore arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 30-Apr-2021, the patient experienced HYPERTENSION (high blood pressure). At the time of the report, HYPERTENSION (high blood pressure) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I had pain at injection site sourness, muscle joint aches. Fatigue, chills. I had a fever of 103.3 that lasted for 3 or 4 days. I went to see the doctor a few days after the symptoms began. I was out of work for about 5 days. I was advised to treat with Tylenol and drink lots of fluid. I was also advised to go to the emergency room if the symptoms got worse. The symptoms subsided after about 5 days. I have made a full recovery.
Atrial fibrillation that evolved to bradycardia and junctional rhythm, unlike previous episodes of AF. Lasted for 8 days and then normalized spontaneously.  Went to ER on 7/6 where EKG was done and referred to cardiologist who said this was most likely due to the vaccine as he has seen this type reaction before.
I had a telehealth appointment with the patient 3/29/21. She tells me she had right shoulder and arm pain after her first dose. Received second dose in left arm without issues. She continues to have shoulder pain and is unclear if this is related to vaccine or not.
Patient had redness, swelling and pain at the injection site, with pain in the arm pit as well; Lymphadenopathy noted on the left arm.