chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt said the following day she felt the side of her face was tingling
Severe burning sensation in feet near toes, pain in knees, pain in hip, pain in shoulders. Could not walk. Symptoms were nearly gone one day later.
The day following the vax the patient's temperature was 101F. The patient was treated with Tylenol. When taken to day care taker, it was noted the patient's eyes were rolling back in his head. 911 was called an arrived within 2 minutes. The seizure lasted less than 30 seconds. There was no seizure activity when the ambulance arrived. Upon examination at the ER the patient was alert and had no further seizures. On 11/27/2001 the patient had a temperature of 102.5-103F. There was no seizure activity. The patient was given a dose of amoxicillin and discharged.
Lt thigh has approx 4cm hard induration, non-tender to palpation or movement; T95.6ax; observe & recheck 23SEP91
Information has been received concerning a pt who on the same day of vaccination developed localized significant redness, swelling, and warmth of the third outer aspect of his upper arm. The pt also developed a fever of 103 and experienced malaise. The pt received unspecified over the counter medications for the fever. The pt recovered in 4 to 5 days.
He is feeling warm right now (today); The area of injection site started getting sore.; On same day after receiving 2nd dose, at night he started with chills.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (He is feeling warm right now (today)), VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.). On 29-Sep-2021, the patient experienced FEELING HOT (He is feeling warm right now (today)). At the time of the report, FEELING HOT (He is feeling warm right now (today)), VACCINATION SITE PAIN (The area of injection site started getting sore.) and CHILLS (On same day after receiving 2nd dose, at night he started with chills.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Pt last seen at 1200 by nurse for ID band check. No visible signs of distress noted. Pt states "I just want to be left alone". 1230 nurse was called to pt room. Pt was noted unresponsive, no pulse and respiration noted. CPR started immediately, at 1239 first shock given. 1245 EMT took over, at 1319 EMT called time of death
11 week old female patient received a first dose of Acthib, and first dose of Daptacel.  The routes of administration were not reported.  As per the reporter, it was not known which leg the vaccines were given in.  3 days later, the patient experienced crying, sleepiness, and swelling in the left and right legs.  The patient was seen by a physician and recovered from the events.
Extreme itchiness in feet and hands the next day.  Rash onset initially  bilaterally in armpit region on day 2.  Rash spread and severity has increased since then until day 4 (today).  The rash is quite red, sensitive to touch, raised and flat-topped. It's spread downward from  armpit to 6-8 inches below armpit on torso and upwards to the underside of the biceps region. By day 3, it also appeared on the inner thighs in the groin area, but not as intensely as the first appearance in the armpit area.  Very slight rash on the palm of left hand.  Itchiness in hands is still present, although not in feet.
Severe stiffness and pain in shoulder around injection site. Persisted for 36 hours before lessening in intensity for an additional 12 hours after which the area returned to normal.
Mom states: Stiffness for about 10 sec. Sent to ED for eval.
Ringing in the ears; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 05Mar2021 at 20:30 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included Cholesterol medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 15Mar2021 at 12:00, the patient experienced ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the ringing in ears was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
White Blood Cell count was low; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (White Blood Cell count was low) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORAZEPAM and COLECALCIFEROL (VITAMIN D3) for an unknown indication, VITAMIN C [ASCORBIC ACID] and EMERGEN C.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT DECREASED (White Blood Cell count was low). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (White Blood Cell count was low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported by patient.
Vesicles on face, abdomen and right thigh (at injection site). Diarrhea (beginning on 12/31/06).
Fever 105.3 documented @ 315PM 19FEB (felt warm prior to that); 3 episodes of vomiting @ 4AM 19FEB; macular rash on abdomen recvd APAP in ER w/ dec of fever to 102.3;
fever of 100.4.; bad pain in legs and feet; lost all colour in her hands and her fingernails were gray; severe joint and muscle aches in legs; severe joint and muscle aches in legs; Loss of appetite.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the third dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07Oct2021 14:00 (02:00 PM) (Lot Number: 30145BA) as DOSE 3 (BOOSTER), SINGLE (received at the age of 67-years-old) for COVID-19 immunisation. The vaccine was administered at a Public Health Clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, high blood pressure, high cholesterol, and known allergy to sulfa drugs. The patient was not pregnant at the time of vaccination and adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6200) as DOSE 1 SINGLE; second dose, via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6208) as DOSE 2 SINGLE for COVID-19 immunisation. The patient previously took tramadol and experienced allergy. On 08Oct2021 04:30 AM, the patient experienced severe joint and muscle aches in legs, and loss of appetite. By 6:00 PM of the same date, she had a fever of 100.4, bad pain in legs and feet, lost all colour in her hands and her fingernails were gray. She spent the rest of evening and night in bed. The patient took Tylenol to break the fever, but she did not receive any corrective treatment for the other reported events. By the next day (09Oct2021), she was much better, just a little run down. Outcome of the events was recovered on an unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.
Approximately 2 weeks post-first shot I developed an outbreak of hives on both hands (clear raised red circles, itchy). I have never had hives of any sort before. The hives lasted approximately 2 days, then disappeared.
102 fever for two full days. Uncontrollable shaking in my body, intense headache, body aches, ringing in left ear, twitching in left hand, poor eyesight. .  Extreme fatigue for 1 week after the shot.
patient had allergic reaction with hives  5 minutes after vaccination. Then patient tongue got thicker a few moment later.
This spontaneous report as received from a physician via a field representative refers to an adolescent male patient who is currently 16 years old. On an unknown date the patient was vaccinated with first dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that there was no adverse event experienced after the first dose. On an unknown date the patient was vaccinated with second dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). On an unknown date (also reported as one day after the second dose was administered) the patient experienced Hives (urticaria) and throat closing (throat tightness). The action taken with the therapy with GARDASIL was unknown. The outcome of urticaria and throat tightness was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
Worsening fatigue, brain fog, shortness of breath, ,numbness and tingling in feet and legs, burning, stinging in feet and legs. Involuntary muscle movements in legs and occasionally the right arm, right hand shaking, occasional double vision, abdominal tingling, dizzyness
Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-357255 (Patient Link).
Vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) in a 38-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Ectopic pregnancy in January 2018, Live birth (Live, full term, birth) on 07-May-2019 and Alcohol use (1-2 drinks/week) from 2004 to May 2020. Concurrent medical conditions included Hypothyroidism since August 2018. Concomitant products included LEVOTHYROXINE for Hypothyroidism, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pregnancy.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-May-2020 and the estimated date of delivery was 15-Feb-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccinated while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 30-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccinated while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Glucose tolerance test: negative (Negative) Negative. On an unknown date, Ultrasound foetal: normal (normal) every monday.     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.   Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Burning pain similar to shingles outbreak to right upper quadrant of abdomen/under right breast.
Mild sore arm, headache, nausea, body aches- all in middle of night, approximately 12 hours after injection
Immediate pain, bruising, huge swelling in arm covering approx 4" circle, raised welt, edema, joint pain in same arm, hard to lift arm. Headache about 3 hrs after for 2+ days, with stiff neck and major eye sensitivity to light for 2+ days.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-AUG-2015, the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. The physician stated that the person who administered the dose of GARDASIL to the patient "was not aware that the patient should be monitored for 15 minutes" and the patient stood up immediately after receiving the dose of GARDASIL and then lost consciousness immediately after standing. When the patient recovered consciousness, the patient was observed to experience an unspecified type of "seizure," and the patient was monitored for an unspecified period of time. The physician reported that the patient was ambulatory when left his office. The outcome of seizure was unknown. The causality was not reported. A product quality issue was not involved. Upon internal review seizure was considered as other important medical event. Additional information is not expected since no permission for further contact was given.
within 10 days I developed Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (within 10 days I developed Covid) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ZINC, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM, ATORVASTATIN, EZETIMIBE (ZETIA), TIZANIDINE HYDROCHLORIDE (ZANAFLEX), FISH OIL, ESCITALOPRAM and LEVOTHYROXINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (within 10 days I developed Covid). The patient was treated with IBUPROFEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. At the time of the report, COVID-19 (within 10 days I developed Covid) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
ringing in the ear when lay down it's when I lay down; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (ringing in the ear when lay down it's when I lay down) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077021D, 010A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ringing in ears.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in the ear when lay down it's when I lay down). At the time of the report, TINNITUS (ringing in the ear when lay down it's when I lay down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Elevated temp of 105 on 07/16/10, 07/17/10, 07/18/10, 07/19/10 and 07/20/10.
SEEN IN ER 9/3/21 FOR COVID pna.  did not get admitted. SEEN AGAIN 9/26/21 for  Shortness of breath in the setting of recent PE/DVT a few weeks ago and more recently COVID 19 pneumonia.  However, ischemic underlying coronary artery disease cannot be ruled out.  It would be reasonable to proceed with stress test using Lexiscan study.   new onset chf. admitted 1 day
Day 0 of shot (4/5): mild headache, began ~6 hour post shot, continued into Day 1 of shot, tapering off on Day 2 Day 1 of shot (4/6): mild fatigue, brain "fog" - tapering off by ~6:00pm
3/29/21 2pm: Headache with progressing level of nausea.    4 pm:  Muscle at injection site beginning to ache,  Extreme migraine-like headache (1-10 pain scale, 8), with nausea and beginning of chills.  5 pm: Took to bed with shivering chills and headache and full body muscle aches.  9 pm-4 am: raking chills, headache and muscle aches (even the tips of my fingers hurt).    3/30/21  8 am: Headache, nausea, and muscle aches ( difficulty moving).  12 pm: Minor reduction in pain levels (1-10 pain scale, reduction from 8 to 7).  6 pm: Major muscle aches and headache and nausea reducing (1-10 pain scale, 7-5).  10 pm: Headache, nausea, and headache reduction (1-10 pain scale, 5-3)
This spontaneous report was received from a medical assistant and refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. No adverse reactions were reported. On an unknown dates, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # reported as M023649 with an expiration date of 11-NOV-2018, and lot # M010212 with an expiration date of 21-JAN-2019 for prophylaxis (strength, dose, route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004019: US-009507513-1701USA005953: US-009507513-1701USA005955: US-009507513-1701USA005956.
Lt thigh red swollen 9" x 6" (DTA area) was given BENADRYL (12.5 mg) 1-6 hrs - 6oz on 4/22/11 2:30pm.
A spontaneous consumer report received via regulatory authority concerns a 3 year old male patient. The patient's medical history and concomitant medications were not reported. On 16-Aug-2013, the patient received nasal FLUMIST quadrivalent (intranasal). Patient had leg pain on 25-Aug-2013 and knee pain on 27-Aug-2013. Patient had lethargy and facial droop on 02-Sep-2013. Patient diagnosed with Guillain-Barre syndrome on 03-Sep-2013 and Patient also had VIIth nerve paralysis. The outcome of the events of VIIth nerve paralysis and Guillain-Barre syndrome were unknown. Reporter assessed the Guillain-Barre syndrome to be serious as hospitalization. The event of VIIth nerve paralysis have been identified by the company physician from the source documents and added as serious adverse events as important medical event.
Pt states Rt arm (+) pain (+) swelling (+) redness. 24 hrs. since vac. now "much better" 14 x 14 cm (+) erythema (+) induration (+) swelling, no pruritus. Pt states night of vac "couldn't stand" but took "alot of meds -> lorazepam, NYQUIL, sleeping pill".
Flu like symptoms; Pain; Chills; Muscle pain/muscle ache; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle pain/muscle ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and VITAMINS NOS for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (Headaches). On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), CHILLS (Chills), MYALGIA (Muscle pain/muscle ache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and SUMATRIPTAN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (Muscle pain/muscle ache) and PYREXIA (Fever) had not resolved.            Treatment information included paracetamol and sumatriptan. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-076192 (Patient Link).