chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Headache; Fatigue; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0175) via an unspecified route of administration in the right arm on 28Apr2021 at 12:30 PM (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0150) in the right arm on 02Apr2021 at 11:00 AM (at the age of 41-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Apr2021 at 07:30, the patient experienced chills, headache, fatigue and soreness at injection site. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events chills, headache, fatigue and soreness at injection site was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 23-year-old, adult, female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse event after the vaccination. This case (201805342) was cross-linked to the original case 201805327 reported by the same reporter. The reporter assessed this case as non-serious. Follow-up received from the nurse on 28-Nov-2018: Age of the patient was added in the patient tab. Route of administration and anatomical location was added in the product tab. It was reported that the patient had not experienced any adverse event after the vaccination. Narrative and case comment were amended accordingly.
Woke up with large, painful swelling of outer right thigh from injection site to knee.  Child limping and complaining of pain. Right thigh measured 29.5cm and left thigh measured 27.75cm on 10/27/15.
Customer is only 63 years old not 65. Called customer when noticed error at 5pm same day. Pt. reports no problem, side effects, or any uncomfort
Patient fainted in reception waiting to go home. She hit her head on the floor and had to be taken to ER for evaluation.
On 9-7-07 pt. received DTAP (LL via IM),IPV LL via SQ),MMR(RL via SQ),and Var.(RL via SQ). Noted redness at LL on 9-7-07.  On 9-8-07 LL noted redness, warmth to touch, and rash.  Went to Hospital on 9-8-07 and ER ordered Keflex.  Rash improved on 9-9-07; however redness and warmth to touch increase. Throughout the above dates; pt's activity remained WNL.  On      9-10-07 pt. returned to our office for re-assessment; rash, redness and warmth to touch  remained to improve. PCP order Keflex 250mg for seven more days.  Pt. to f/u on 9-12-07.  DX. Immunologic Reaction vs. Cellulitis.
PAIN IN BACK AND FRONT OF HEAD RADIATING DOWN THE NECK; TROUBLE SLEEPING; This spontaneous report received from a consumer concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 01-JUL-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced pain in back and front of head radiating down the neck. On 12-JUN-2021, the subject experienced trouble sleeping. Laboratory data included: Blood test (NR: not provided) no problem found, Computerised tomogram (NR: not provided) normal, and Magnetic resonance imaging (NR: not provided) no problem found. Treatment medications included: morphine. Additional treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in back and front of head radiating down the neck, and trouble sleeping. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Patient developed diarrhea and sore throat about 15 days after vaccination. This turned into severe anxiety, chronic fatigue and then depression with weight loss. He missed a lot of school. He is still very anxious and has trouble with daily activities.
3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21:  10:30 pm nausea 3/14/21:  11:00 pm vomiting every hour - 7 hours and off and on the next 48 hours 3/15/21:  10:00 am extreme joint pain  48 hours 3/15/21:  10:00 am  headache off and on 72 hours 3/16/21:  3:00 am 102.4 temperature (couple of hours?)16 3/16/21:   12:00 pm sore throat 24 hours 3/16/21:   Fatigue Continues 3/16/21:   Very dizzy 3/17/21:  3:00 pm injection side tenderness and slight swelling 48 hours 3/18/21:  3:00 pm first time able to get out of bead and shower - slight light headedness
pt woke mom making an awful noise when breathing;taken to ER;pt had audible stridor, SOB/resp distress & fever-T104;dx croup;pt also exp tachycardia about 200;pt given med for tx;Annual follow-up received on 12/11/00 states the child has recovered and can resume vaccinations.
Muscle pain; Joint soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and ARTHRALGIA (Joint soreness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (Muscle pain) and ARTHRALGIA (Joint soreness). At the time of the report, MYALGIA (Muscle pain) and ARTHRALGIA (Joint soreness) outcome was unknown. Not Provided          Concomitant Product use was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to events was not applicable.
This case was reported by a pharmacist via call center representative and described the occurrence of hard of hearing in a 72-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date January 2020). Previously administered products included CRESTOR (received generic CRESTOR a year before the reporting date). On 22nd March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 2 days after receiving SHINGRIX, the patient experienced hard of hearing. On an unknown date, the outcome of the hard of hearing was unknown. It was unknown if the reporter considered the hard of hearing to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in his left arm, and 2 to 3 days later experienced difficulty hearing in his right ear. The reporter stated that the patient was not sure if the condition had worsened, and was not certain of causality in relation to SHINGRIX. This case has been linked with case US2018063434 reported by same reporter.
now he is dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (now he is dizzy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced DIZZINESS (now he is dizzy). At the time of the report, DIZZINESS (now he is dizzy) had not resolved.            No concomitant medications were mentioned. No treatment details were reported. Upon reading the FAQ on side effects and advising to call their HCP or go the nearest hospital, caller disconnected the call. No other details were provided.
Vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ocrelizumab (Ocrevus) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information document received on 28-APR-2021 Contains updated concomitant medications.
This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the PNEUMOVAX 23 was of 19 °C for a time frame of 11 hours. Previous temperature excursion occurred; however, the temperature information was unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of five reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA008598: US-009507513-1705USA008600: US-009507513-1705USA008602: US-009507513-1705USA008605.
Pt received HPV9 and within 1 min of vaccine administration complained of dizziness. Pt was seated in a recumbent position chair. Pt. experienced a vasovagal response lasting less than 5 seconds. Pt's regained consciousness, was A&O x4 with stable vitals.
GAVE CHILD AN ADULT DOSE VACCINE (1ML) RATHER THAN A CHILD DOSE (0.5ML). PER CONVERSATION W/PARENT THAT SAME DAY, CHILD DID NOT HAVE PROBLEMS. PARENT HAS NOT REPORTED PROBLEMS UP TO THIS DATE.
5 minutes after first vaccine, pt had rapid heart rate, Chest "heavyness", started Bilat. tremors, feeling faint, reported difficulty breathing; ambulance summoned, Pulse ox 98 , heartrate 115-125
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as: M024678 with expiration date: 08-MAY-201, lot # reported as: M000997 with expiration date: 07-JAN-2018, lot # reported as: L044524 with expiration date: 09-NOV-2017 and lot # reported as: L043622 with expiration date: 03-NOV-2017 (doses and routes of administration were not reported). There were no adverse effects reported. The administered doses of vaccine experienced a temperature excursion of maximum 15.2 Fahrenheit for 2 hours and 8 minutes. Data logger was involved and there was no previous temperature excursion reported. There was any Product Quality Complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a RN concerning a 6 month old female who was vaccinated with Comvax. The pt was also vaccinated with the second dose of Prevnar and ACEL-IMUNE on the same day. Four days post immunization, the pt developed a fever greater than 102.2 F and rash. No further details were provided. Additional information has been requested.
02aug90 pt vax hepta b. 24hrs aft vax pt devel numbness and tingling of rt leg. 48hrs aft vax pt unable to move rt leg and ex no sensation from hip to knee. sx subsided w/i 8 hrs, but continued to ex paresthesia of upper rt leg.
Itchy, red, flat red rash, runny nose second day after flu vaccine. Questionable if Viral exanthum.
This case was reported by a nurse via sales rep and described the occurrence of hives in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that hives appeared within 3 days of vaccination with indeterminate length of symptoms. The reporter agreed to be followed up.
The client contracted COVID-19 even after receiving both doses in a series of the vaccine. The client experienced a cough, muscle aches, loss of taste and smell, nasal congestion, headache and fatigue.
Back Pain; did not have the mental capacity to get water; Excessive sweating; Severe fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gout. Concurrent medical conditions included Hyperlipidemia. Concomitant products included ATENOLOL for Hypertension.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC) for Fever, at an unspecified dose and frequency. On 14-Jun-2021, BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved.            The patient has used hydration and blankets to try and counteract the symptoms. He stopped taking cholesterol injection but will resume taking on 16-JUL-2021   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: FU received, updated patient medical history
RN administered the shot but only injected 0.1 ml because of difficulty with unfamiliar syringe.  Then she administered the remaining 0.2 ml to complete the dose approximately 10 minutes later.
No reaction to the vaccine. On 11/06/2022 I started to not feel well with symptoms of stuffy nose, slight cough, slight muscle aches, no fever and no shortness of breath. I tested positive for COVID-19 with a home test and later with a PCR on 11/14/2022. I called my doctor and prescribed amoxicillin, MUCINEX and prednisone which helped with my symptoms.
Immediately felt like I could feel it in my upper stomach area,  started not feeling well. Then mouth felt weird and a little itchy, took a teaspoon of Benadryl and it stopped. Started feeling extremely weak and head hurt severely so the nurse took blood pressure and it was 160/96 way higher than normal for me (usually 120/74). Then pain in jaw for only about 60 seconds, nurse sent me to ER.  By the time I got there blood pressure was back to normal so went home slept the rest of the day and night, by morning was back to normal but stomach hurt for a couple of days, no pain in arm.
Developed sore throat 24 hours after vaccines exudative tonsillitis with neg strep, CBC nl. Past hx mono and rash developed day 6. Day 7 rash -> urticarial, throat clearing.
Pain localized to thigh, developed swelling, edema and later erythema. Pain to walk. Treated with local ice pack, gave Benadryl every 6 hours for next 48 hours and Tylenol for pain. Monitor at home and via phone call.
patient presented to the pharmacy on 6/4 and reported she had a severe reaction to her Shingrix vaccine she was given on 5/16. she described the reaction as severe sweating, fatigue, an increased heart rate, and she even blacked out. she received the vaccine around 10:00am on 5/16 and she reported that these events happened later that day around 7:00pm. she had the first does with only mild reaction (fatigue, soreness), so she was concerned when this happened with the second dose. i asked if she sought any medical attention at the ime of or after the adverse event occured and she said no. she said the next day she felt fine. but she wanted us to know her reaction so it could potentially help other patients in the future who may suffer the same adverse effects after getting the vaccine
This spontaneous report was received from a Medical Assistant referring to a 31 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 24-APR-2017, the patient inadvertently received an expired dose of VARIVAX for prophylaxis, lot # L013826 with expiration date of 21-APR-2017 (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored doses of the ROTATEQ (dose, lot# and expiry date were not reported) was administered orally to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
03/04/22 presents to ED for "Vomiting, Chest Pain". PMHx of "HFrEF s/p AICD, HTN, HLD, PE on eliquis, CKD"
Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 195/110 ) leg pain, muscle aches
Patient received the Pfizer vaccine on 4/21/2021 - Pfizer EW0169.  The patient was then administered a Moderna vaccine rather than the Pfizer for their second dose.
Narrative: Patient recieved vaccines in Jan(11, 2021) and Feb from a pharmacy. Patient hospitalized with covid/sepsis on 11/8. reported per EUA
On Saturday AM 7/13/02, patient complained of itching under both arm pits and across chest. Spot also on back above right buttocks. Mom applied Triancinolone/Acetonide and oral Benadryl. Better that night. Sunday, itching all over/more spots (red under skin) on back, chest, underarms/arms. benadryl and cream applied. Monday better so went to camp. Tuesday, elevated rash, elevated  itching, blisters standing/forming all over body. Wednesday AM, saw doctor camp uses for emergencies. Lab test done. Put on E. Mycin and Benadryl.
Pt called from a pharmacy - states she received Gardasil vaccine this AM at our office - she is now experiencing nausea, stomach cramps, headache and generalized malaise - advised to call parent to take her home from mall - Benadryl 25mg - if SOB, chest pain or other severe symptoms, pt to go to ER.
On May 31,2021 I began to suffer with headache by June2,2021 at 1 in the morning I couldnt take it anymore and had sept most of the 3 days...then I began to have neck stiffness to the point I could not move...My son called 911 they took me to the hospital where they did ct scan and found i was bleeding by my brain, then I was life flighted to another hospital and addmitted to neurological icu unit and told i suffered subarachnoid hemorrhage and a stroke...I was discharged on June 8,2021
Swelling (size of softball), redness, warm, hard to the touch. Patient was put on 7 day course of cephalexin 500 mg 1 capsule 4 times daily.
She got her vaccine and woke up at 2:35 AM with the urge to use the restroom and before she could get up she found out that her head was hurting real bad.  She used the wheelchair and when she came back she fell down and was on the floor.  They called and they put her in the bed and thought she was scooting into the middle of the bed and she scooted to the end of the bed and fell to the floor again.  They called again and they put her back in the bed.   She still had the excruciating headache, took some Tylenol and it relieved her pain.  Her legs seemed weak but is unable to stand for long.  She does use a wheelchair on a regular basis as she cannot walk.
Sudden acute hearing loss in left ear approximately 28 hours post-vaccination. Assessment at urgent care including  visual inspection of ears and both air and bone conduction hearing test. 10-day course of 60 mg po prednisone started approx 20 hours after hearing loss onset. Extensive audiology exam showing 4k notch hearing loss of greater significance in left ear.
First 6-8 hrs the Left Arm was Sore 2-3/10  on Pain scale.  After 8 hours, unable to move arm away from body related to the Pain, now a 10/10.  This Pain level last for about 24hours.