chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very light headed; slight pain in my neck.; cold sweat; nauseous; extremely tired; shivering so uncontrolably; started throwing up\thought entire insides were about to come out; headache; trembling; pain in stomach on right side; body felt like it was on fire inside and outside; unreal pain all over the entire body,; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,) and DIZZINESS (very light headed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteo arthritis knees on 01-Jan-2005. Concurrent medical conditions included Allergy and Allergy. Concomitant products included ACETAMINOPHEN from 10-Oct-2005 to an unknown date for Arthritis, LOSARTAN from 10-Oct-2015 to an unknown date for Blood pressure, SIMVASTATIN from 10-Oct-2015 to an unknown date for Cholesterol, COLECALCIFEROL, UBIDECARENONE (COQ10 + D3) from 10-Oct-2015 to an unknown date for Vitamin A.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,), VOMITING (started throwing up\thought entire insides were about to come out) and HEADACHE (headache). On an unknown date, the patient experienced DIZZINESS (very light headed), NECK PAIN (slight pain in my neck.), COLD SWEAT (cold sweat), NAUSEA (nauseous), FATIGUE (extremely tired) and CHILLS (shivering so uncontrolably). At the time of the report, TREMOR (trembling), ABDOMINAL PAIN UPPER (pain in stomach on right side), BURNING SENSATION (body felt like it was on fire inside and outside), PAIN (unreal pain all over the entire body,), DIZZINESS (very light headed), NECK PAIN (slight pain in my neck.), COLD SWEAT (cold sweat), VOMITING (started throwing up\thought entire insides were about to come out), HEADACHE (headache), NAUSEA (nauseous), FATIGUE (extremely tired) and CHILLS (shivering so uncontrolably) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional info received
arm is still very sore; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. In October 2021, less than 2 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had second dose of Bexsero a week ago and his/her arm was still very sore.
24 hoursMalaise; flu like symptoms; This is a spontaneous report from a non-contactable Physician reporting for herself. The case was also reported via Pfizer employee. A 32-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at single dose in the right arm for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 administered on an unspecified date. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive concomitant medications. On 08Jan2021 the patient experienced 24 hours malaise and in Jan2021 flu like symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19. The patient received treatment with paracetamol (TYLENOL) for the event malaise. Malaise resolved on 09Jan2021, while outcome of flu like symptoms was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
patient started feeling weak, dizzy and even blacked out a couple times; patient started feeling weak, dizzy and even blacked out a couple times; patient started feeling weak, dizzy and even blacked out a couple times; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2, via an unspecified route of administration, on 16Dec2020 at 12:00 PM at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 17Dec2020, at around 1:00 in the morning, the patient started feeling weak, dizzy and even blacked out a couple times. The outcome of the events was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events  feeling weak, dizzy and blacked out, there is a reasonable possibility that the events are related to BNT162 vaccine. The case will be reassessed upon receipt of follow up information.
Left arm: swelling, site of injection was elevated and enlarged  -frontal headaches/ eye pain -chills -general body aches
3hr p/vax pt presented w/hives over entire body;was taken to PMD the following day & prescribed DPH-hives lasted for 3 days;
Had left clinic p/receiving MMR, was walking down the hall & became lightheaded, color pale, skin cool & clammy; No LOC;
On November 30 I began to feel in the evening chills and fever.  I then had a sore throat, fatigue and joint aches on the same evening.  The next day, December 1st I tested positive for COVID-19 on a home test.  I visited the clinic and got a PCR that was positive.  I had telehealth visit with my doctor and was prescribed Paxlovid. After I began taking this, I would wake up with a medicinal taste in the back your throat.  As of today, the only symptom I still have is fatigue.
about 4 wks after vaccine started getting large (some 4"} hives over body   Sore and itchy.   Have had multiple blood work ups.  Biopsies done allergy testing.   No reason found for hives.    Also, reacted to first vaccine with large red area on arm 8 days later.  they want to start me on Xolair and see a need for me to carry an epi-pen also taking prednisone, allegra and zyzal
Child started having a rash on the back of her right arm 3 inches x 4 inches, itchy and felt weird on 1-22-13. Mom took her to see Dr. & was diagnosed with shingles. Acyclovir was prescribed for 2 weeks.
Information has been received via a 34 year old female who on an unspecified date was vaccinated with a dose of Pneumovax 23 (manufacturer not specified). Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced redness at vaccine site, swollen at vaccine site, hot reaction at vaccine site, achy and fever during administration. The outcome and causality of the event were not reported. No further information is available.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
p/vax pt screamed intensely & lower extremities developed hives, swollen, hot to touch, bright red rash phenomenon;pt calmed down all sx resolved;pt became dusky in pallor & required amb to take to ER;given epi;adm to hosp;
Extreme headache for 3 days. Started the morning of the next day after the shot. Mild headache for another 2 days. High fever for 3 days. Followed by fever only at night for 4 more days. Soreness in all major joints for 3 days. Extreme fatigue for 4 days.
Patient was fully vaccinated and tested positive for COVID-19 on 08/04/2021.
Orange size, painful, inflammed mass in axilla lymph node following day after receiving vaccination.  Extremely sore entire arm for 2 days following injection- worst in life with vaccinations.  Open and painful sore in roof of mouth also noted within 24 hours of receiving shot
This spontaneous case reported by a consumer, describes the occurrence of intentional product use issue (patient had to reschedule her second dose; second dose will be on day 36) and fatigue (very tired for a day or two) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced intentional product use issue (patient had to reschedule her second dose; second dose will be on day 36) and fatigue (very tired for a day or two). At the time of the report, intentional product use issue (patient had to reschedule her second dose; second dose will be on day 36) and fatigue (very tired for a day or two) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication, treatment information or lab data provided.
Left throat lymph node swollen; Rash on right arm partially on left arm and lower legs); Genital sores; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6Z06), via an unspecified route of administration in the left arm on 11Mar2021 at 14:00 (at the age of 30-years-old), as a single for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 14Mar2021, the patient experienced swollen lymph nodes in left throat, rash on right arm (partially on left arm and lower legs) and genital sores. The patient did not receive any treatments for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events swollen lymph nodes, the rash on legs and arms and the genital pain were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information expected.
Within 24 hours of receiving the second dose of Moderna, I was peeing blood. It started out as a light pink and turned darker throughout the day. I went to the doctors and was given a CBC, Complete Metabolic Panel, and Urinalysis that was sent to the lab. Everything came back normal-no infection, kidney function looked great, etc. The visible signs in my blood lasted three days. I went to the doctor 6 days later and there was still microscopic evidence of blood, but no visible amounts. Since all tests were normal, they told me not to worry about it.
Hour after flu vaccine, patient had loss of sensation: left arm and rest of body. Curled up in fetal position. Went to Hospital ER: had second episode 24 hours later. Went to hospital ER.
Mild redness at injection site.  Nodules under injection site.  Unusual and extreme irritability following infjection
made her go to sleep peacefully/ Had a full nights sleep; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "made her go to sleep peacefully/ Had a full nights sleep".  Additional information: Caller declined to provide phone number as she did not remember since she just recently changed it. Caller stated she was calling to report that everything was fine and her only reaction she had after receiving the first dose of the Pfizer COVID vaccine on 20Apr2021 was that it made her go to sleep peacefully and she had a full nights sleep. Caller stated she did not have a question and just wanted to report that everything was okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after receiving the first dose, I developed a very salty taste in my mouth.  I also noticed a pungent odor to my urine.  My research suggested that I may be dehydrated, and I contacted my PCP, who suggested that I increase my water intake, which I did, and this was back ~20 March.   I have increased my water intake since than, adding ~1-2 liters per day; there has been no change to my symptoms.  I'm thinking I should perhaps go visit him
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 lot # L007560/expiration date- 15-JUN-2017, (incorrect product storage). No adverse event. Excursion temperature was 31 F and timeframe was 152 days (worst case). There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up the morning of 9/25  with trouble breathing. This was ~19 hours after 2nd dose. Held off for a day and checked myself into ER. Cardiologist at ER diagnosed me with acute pericarditis and sent me home without meds since the meds typically used to treat acute pericarditis are not used for pregnant women. On Monday 9/27 I had a 34 week OB-GYN checkup. Doctor saw me and urged me to go to the hospital where she delivers as soon as possible. My husband and I drove to Hospital. Was checked into ER and sent to the Telemetry department. Dr's there did blood work and an echocardiogram and confirm that I have acute pericarditis.   Was advised to deliver baby ASAP so that the appropriate meds can be used to help my symptoms. Was induced and gave birth on 10/1 to a baby 34 weeks and 5 days old.
Could hardly lift my arm; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Could hardly lift my arm), CHILLS (Chills) and VACCINATION SITE PAIN (Arm soreness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Could hardly lift my arm), CHILLS (Chills) and VACCINATION SITE PAIN (Arm soreness). At the time of the report, INJECTED LIMB MOBILITY DECREASED (Could hardly lift my arm), CHILLS (Chills) and VACCINATION SITE PAIN (Arm soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Rash began on neck - spreading on arm and face. Has appropriately 15 papules total. Symptomatic treatment at home.
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 25-OCT-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Vaccine Adverse Event (make sure DOB, age, health conditions/allergies, and current medications coded on front screen). 26 year old female received the 2nd dose of the Pfizer COVID-19 vaccine at the Convention Center on 04/08/2021 @ 08:00. Pt started experiencing a fever on 04/09/2021, highest temp recorded was 102.9F now 98.9F, but temp goes up to 101F in the evening when sleeping. On 04/10/2021 pt started experiencing hives (red, raised, itchy patches) on both sides of the hips and the upper right arm (opposite arm in which the vaccine was administered). Pt is allergic to penicillin and amoxicillin. Pt took cetirizine before calling. Pt takes Metformin 750mg and has polycystic ovary syndrome. Pt was advised to go to the ER in case this could be an allergic hives reaction. SPI was consulted and Dr. was notified.
Information has been received from a nurse via a company representative regarding a patient (gender and age not specified) who in approximately 2004 received the pneumococcal 23v polysaccharide vaccine (Lot# not provided). subsequently, the patient developed localized erythema and painful swelling. The out come was unknown. No further information is available.
Kidney Failure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 at 14:30 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient has no medical history and no known allergies. The patient's concomitant medications were not reported. Facility type vaccine was other. No other vaccine in four weeks. The patient experienced kidney failure on 25Mar2021 at 06:30. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for kidney failure for 7 days. Treatment was received for the adverse event. The patient underwent lab tests and procedures which included Covid test nasal swab: negative on 25Mar2021 and negative on 07Apr2021. The outcome of the event was recovered with lasting effects.  Information about lot/batch number has been requested.
patient forgot she had received her booster already and came in for her another one.  It was not caught until after the patient had went home.  migraine headache, hallucinations
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-APR-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-FEB-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles along with shingles affecting the right eye. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Upon internal review, shingles affecting the right eye was determined to be medically significant. Additional information has been requested.
Dose was given from a potentially expired vial. No signs or symptoms reported. The expired vials were quarantined and separated. The patient was informed.
Last date of menstrual cycle was October 3. Confirmed pregnancy between 4 and 5 weeks. Flu shot was received around 12:00pm, bleeding/miscarriage occurred at 8pm and confirmed in ER the next day.
Since the vaccine I have suffered great gastro-intestinal issues, neurological impairment, loss of cognitive function, inability to work,  chronis sinus issues, dorsal shutdown and damage to vagus nerve, numerous ear infections, numerous lung infections, was diagnosed with fibromyalgia, have been puking up over a cup of  phelgm a day with black specks in it for over a year, urinary issues, reproductive organ issues, issues with my liver and kidneys, prediabetes, precancer, infections in my jaw and a full blown systemic infection I just got out of the hospital for.